adenine has been researched along with Atrial Fibrillation in 60 studies
Atrial Fibrillation: Abnormal cardiac rhythm that is characterized by rapid, uncoordinated firing of electrical impulses in the upper chambers of the heart (HEART ATRIA). In such case, blood cannot be effectively pumped into the lower chambers of the heart (HEART VENTRICLES). It is caused by abnormal impulse generation.
Excerpt | Relevance | Reference |
---|---|---|
"In patients with atrial fibrillation, beta-fibrinogen 455 G/A gene polymorphism is associated with the presence of left atrial thrombus and severe SEC." | 7.76 | The association of beta-fibrinogen 455 G/A gene polymorphism with left atrial thrombus and severe spontaneous echo contrast in atrial fibrillation. ( Akdeniz, B; Aslan, A; Badak, O; Bariş, N; Bozdemir, V; Güneri, S; Kala, V; Kirimli, O; Ozel, E; Senarslan, O; Ulgenalp, A, 2010) |
" Ibrutinib use, age, hypertension, and previous use of ACE inhibitors, angiotensin receptor blocker use, β blocker use, and aspirin use were independently associated with incident arrhythmias." | 3.91 | Rates and Risk of Atrial Arrhythmias in Patients Treated With Ibrutinib Compared With Cytotoxic Chemotherapy. ( Armanious, M; Chavez, JC; Emole, J; Fradley, MG; Gliksman, M; Lee, DH; McLeod, H; Pinilla-Ibarz, J; Rhea, I; Schabath, MB; Shah, B; Viganego, F; Walko, C; Welter-Frost, A, 2019) |
"In patients with atrial fibrillation, beta-fibrinogen 455 G/A gene polymorphism is associated with the presence of left atrial thrombus and severe SEC." | 3.76 | The association of beta-fibrinogen 455 G/A gene polymorphism with left atrial thrombus and severe spontaneous echo contrast in atrial fibrillation. ( Akdeniz, B; Aslan, A; Badak, O; Bariş, N; Bozdemir, V; Güneri, S; Kala, V; Kirimli, O; Ozel, E; Senarslan, O; Ulgenalp, A, 2010) |
"Ibrutinib has superior progression-free survival compared with bendamustine plus rituximab (BR) in older CLL patients, however, differences in treatment duration, six monthly BR cycles versus continuous ibrutinib, complicate adverse event (AE) comparisons." | 3.01 | Adverse event burden in older patients with CLL receiving bendamustine plus rituximab or ibrutinib regimens: Alliance A041202. ( Abramson, JS; Bartlett, NL; Booth, AM; Brander, DM; Brown, JR; Byrd, JC; Coutre, S; Ding, W; Erba, H; Kuzma, CS; Larson, RA; Little, RF; Litzow, M; Mandrekar, SJ; Nattam, S; Owen, C; Ruppert, AS; Smith, SE; Stone, RM; Woyach, JA, 2021) |
" In the integrated analysis (ibrutinib treatment up to 43 months), the most common adverse events (AEs) were primarily grade 1/2; diarrhea (n = 173, 52% any-grade; n = 15, 5% grade 3) and fatigue (n = 119, 36% any-grade; n = 10, 3% grade 3)." | 2.90 | Long-term safety of single-agent ibrutinib in patients with chronic lymphocytic leukemia in 3 pivotal studies. ( Barr, PM; Barrientos, JC; Burger, JA; Byrd, JC; Chang, S; Coutre, SE; Dean, JP; Devereux, S; Furman, RR; Ghia, P; Hillmen, P; James, DF; Kipps, TJ; Moreno, C; O'Brien, SM; O'Dwyer, M; Robak, T; Schuh, A; Valentino, R, 2019) |
"Among patients with Waldenström's macroglobulinemia, the use of ibrutinib-rituximab resulted in significantly higher rates of progression-free survival than the use of placebo-rituximab, both among those who had received no previous treatment and among those with disease recurrence." | 2.87 | Phase 3 Trial of Ibrutinib plus Rituximab in Waldenström's Macroglobulinemia. ( Buske, C; Dimopoulos, MA; García-Sanz, R; Graef, T; Herbaux, C; Kastritis, E; Leblond, V; Li, J; Macdonald, D; Mahe, B; Matous, JV; Orsucci, L; Palomba, ML; Salman, Z; Shustik, C; Tam, C; Tedeschi, A; Treon, SP; Trotman, J, 2018) |
"Ibrutinib combined with rituximab is active and well tolerated in patients with relapsed or refractory mantle cell lymphoma." | 2.82 | Ibrutinib in combination with rituximab in relapsed or refractory mantle cell lymphoma: a single-centre, open-label, phase 2 trial. ( Addison, A; Badillo, M; Champlin, R; Chen, W; Chuang, H; DeLa Rosa, M; Fayad, L; Hagemeister, F; Lam, L; Lee, H; Li, S; Medeiros, LJ; Nomie, K; Oki, Y; Romaguera, J; Samaniego, F; Santos, D; Turturro, F; Wagner-Bartak, N; Wang, ML; Westin, J; Young, KH; Zhang, H; Zhang, L; Zhao, D, 2016) |
"Between Sept 19, 2012, and Jan 21, 2014, 578 eligible patients were randomly assigned to ibrutinib or placebo in combination with bendamustine plus rituximab (289 in each group)." | 2.82 | Ibrutinib combined with bendamustine and rituximab compared with placebo, bendamustine, and rituximab for previously treated chronic lymphocytic leukaemia or small lymphocytic lymphoma (HELIOS): a randomised, double-blind, phase 3 study. ( Avigdor, A; Balasubramanian, S; Bartlett, NL; Chanan-Khan, A; Cramer, P; Demirkan, F; Dilhuydy, MS; Fraser, G; Goy, A; Grosicki, S; Hallek, M; Howes, A; Janssens, A; Karlsson, C; Loscertales, J; Mahler, M; Mato, A; Mayer, J; Panagiotidis, P; Pavlovsky, MA; Phelps, C; Pristupa, A; Pylypenko, H; Rule, S; Salman, M; Samoilova, O; Silva, RS; Sun, S; Villa, D, 2016) |
"Advances in the molecular biology of chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) and development of molecularly targeted therapies have resulted in treatment innovations." | 2.66 | Evolution in the management of chronic lymphocytic leukemia in Japan: should MRD negativity be the goal? ( Suzumiya, J; Takizawa, J, 2020) |
" Here side effects of ibrutinib have been summarized and important considerations in the management of these adverse events have been reviewed." | 2.61 | Management of adverse effects/toxicity of ibrutinib. ( Paydas, S, 2019) |
"Overall, AF and bleeding are manageable clinical events in patients receiving IB, not requiring drug interruption in most cases." | 2.58 | Practical management of ibrutinib in the real life: Focus on atrial fibrillation and bleeding. ( Boriani, G; Corradini, P; Cuneo, A; Falanga, A; Foà, R; Gaidano, G; Ghia, PP; Marasca, R; Martelli, M; Massaia, M; Mauro, FR; Minotti, G; Molica, S; Montillo, M; Pinto, A; Tedeschi, A; Vitolo, U; Zinzani, PL, 2018) |
"Results from several recent studies in chronic lymphocytic leukemia (CLL) have demonstrated an association between ibrutinib exposure and the development of atrial fibrillation, estimated incidence of 11% with long-term follow up." | 1.48 | Left atrial abnormality (LAA) as a predictor of ibrutinib-associated atrial fibrillation in patients with chronic lymphocytic leukemia. ( Ali, N; Carver, J; Clasen, S; Gashonia, L; Hughes, M; Mato, AR; Nabhan, C; Pickens, P; Rhodes, J; Schuster, S; Svoboda, J, 2018) |
" There was no inducibility difference after chronic dosing with washout." | 1.48 | Increased Susceptibility for Atrial and Ventricular Cardiac Arrhythmias in Mice Treated With a Single High Dose of Ibrutinib. ( Jones, DL; Tuomi, JM; Xenocostas, A, 2018) |
"We investigated the genetic predisposition in IL-6 response to coronary revascularization and studied the association between the G-174C polymorphism, IL-6 levels, and clinical outcomes of surgery." | 1.33 | Interleukin 6 G-174C polymorphism influences outcome following coronary revascularization surgery. ( Barnard, J; Bittar, MN; Carey, JA; Fildes, JE; Hutchinson, IV; Pravica, V; Yonan, N, 2005) |
Timeframe | Studies, this research(%) | All Research% |
---|---|---|
pre-1990 | 0 (0.00) | 18.7374 |
1990's | 0 (0.00) | 18.2507 |
2000's | 1 (1.67) | 29.6817 |
2010's | 41 (68.33) | 24.3611 |
2020's | 18 (30.00) | 2.80 |
Authors | Studies |
---|---|
Tuomi, JM | 2 |
Bohne, LJ | 1 |
Dorey, TW | 1 |
Jansen, HJ | 1 |
Liu, Y | 1 |
Jones, DL | 2 |
Rose, RA | 1 |
Onitilo, AA | 1 |
Piwuna, TO | 1 |
Islam, N | 1 |
Furuya-Kanamori, L | 1 |
Kumar, S | 1 |
Doi, SAR | 1 |
Stühlinger, MC | 1 |
Weltermann, A | 1 |
Staber, P | 1 |
Heintel, D | 1 |
Nösslinger, T | 1 |
Steurer, M | 1 |
Yang, X | 1 |
An, N | 1 |
Zhong, C | 1 |
Guan, M | 1 |
Jiang, Y | 1 |
Li, X | 1 |
Zhang, H | 2 |
Wang, L | 1 |
Ruan, Y | 2 |
Gao, Y | 1 |
Liu, N | 2 |
Shang, H | 1 |
Xing, Y | 2 |
Koehler, A | 1 |
Lewicka, E | 1 |
Daniluk, P | 1 |
Lasocka, Z | 1 |
Zarzycka, E | 1 |
Dąbrowska-Kugacka, A | 1 |
Nabiałek-Trojanowska, I | 1 |
Zaucha, JM | 1 |
Suzumiya, J | 1 |
Takizawa, J | 1 |
Archibald, WJ | 1 |
Rabe, KG | 1 |
Kabat, BF | 1 |
Herrmann, J | 1 |
Ding, W | 3 |
Kay, NE | 2 |
Kenderian, SS | 1 |
Muchtar, E | 1 |
Leis, JF | 2 |
Wang, Y | 1 |
Chanan-Khan, AA | 2 |
Schwager, SM | 2 |
Koehler, AB | 1 |
Fonder, AL | 1 |
Slager, SL | 2 |
Shanafelt, TD | 2 |
Call, TG | 2 |
Parikh, SA | 2 |
Xiao, L | 1 |
Salem, JE | 1 |
Clauss, S | 1 |
Hanley, A | 1 |
Bapat, A | 1 |
Hulsmans, M | 1 |
Iwamoto, Y | 1 |
Wojtkiewicz, G | 1 |
Cetinbas, M | 1 |
Schloss, MJ | 1 |
Tedeschi, J | 1 |
Lebrun-Vignes, B | 1 |
Lundby, A | 1 |
Sadreyev, RI | 1 |
Moslehi, J | 1 |
Nahrendorf, M | 1 |
Ellinor, PT | 1 |
Milan, DJ | 1 |
Şener, YZ | 1 |
Santoro, RC | 1 |
Falbo, M | 1 |
Levato, L | 1 |
Iannaccaro, P | 1 |
Prejanò, S | 1 |
Lim, KJC | 1 |
Tam, CS | 4 |
Awan, FT | 1 |
Tong, D | 1 |
Zaha, VG | 1 |
Pellegrini, L | 1 |
Novak, U | 1 |
Andres, M | 1 |
Suter, T | 1 |
Nagler, M | 1 |
Singh, A | 1 |
El Hangouche, N | 1 |
McGee, K | 1 |
Gong, FF | 1 |
Lentz, R | 2 |
Feinglass, J | 2 |
Akhter, N | 2 |
Ciuculete, DC | 1 |
Popescu, RA | 1 |
Dan, GA | 1 |
Ruppert, AS | 1 |
Booth, AM | 1 |
Bartlett, NL | 2 |
Brander, DM | 1 |
Coutre, S | 1 |
Brown, JR | 3 |
Nattam, S | 1 |
Larson, RA | 1 |
Erba, H | 1 |
Litzow, M | 1 |
Owen, C | 1 |
Kuzma, CS | 1 |
Abramson, JS | 1 |
Little, RF | 1 |
Smith, SE | 1 |
Stone, RM | 1 |
Byrd, JC | 3 |
Mandrekar, SJ | 1 |
Woyach, JA | 1 |
Sestier, M | 1 |
Hillis, C | 2 |
Fraser, G | 3 |
Leong, D | 1 |
Wasserstrum, Y | 1 |
Raanani, P | 1 |
Kornowski, R | 1 |
Iakobishvili, Z | 1 |
Chai, KL | 1 |
Rowan, G | 1 |
Seymour, JF | 2 |
Burbury, K | 1 |
Carney, D | 1 |
Aw, A | 1 |
Thorp, BC | 1 |
Badoux, X | 1 |
Ali, N | 2 |
Malik, F | 1 |
Jafri, SIM | 1 |
Naglak, M | 1 |
Sundermeyer, M | 1 |
Pickens, PV | 1 |
Tang, CPS | 1 |
McMullen, J | 1 |
Tam, C | 2 |
Mato, AR | 1 |
Clasen, S | 1 |
Pickens, P | 1 |
Gashonia, L | 1 |
Rhodes, J | 2 |
Svoboda, J | 1 |
Hughes, M | 1 |
Nabhan, C | 1 |
Schuster, S | 1 |
Carver, J | 1 |
Gribben, JG | 1 |
Bosch, F | 1 |
Cymbalista, F | 2 |
Geisler, CH | 1 |
Ghia, P | 2 |
Hillmen, P | 2 |
Moreno, C | 2 |
Stilgenbauer, S | 1 |
Xenocostas, A | 1 |
Boriani, G | 1 |
Corradini, P | 1 |
Cuneo, A | 1 |
Falanga, A | 1 |
Foà, R | 1 |
Gaidano, G | 1 |
Ghia, PP | 1 |
Martelli, M | 1 |
Marasca, R | 1 |
Massaia, M | 1 |
Mauro, FR | 1 |
Minotti, G | 1 |
Molica, S | 1 |
Montillo, M | 1 |
Pinto, A | 1 |
Tedeschi, A | 2 |
Vitolo, U | 1 |
Zinzani, PL | 1 |
Mato, A | 2 |
Sharman, JP | 1 |
Dimopoulos, MA | 1 |
Trotman, J | 1 |
García-Sanz, R | 1 |
Macdonald, D | 1 |
Leblond, V | 1 |
Mahe, B | 1 |
Herbaux, C | 1 |
Orsucci, L | 1 |
Palomba, ML | 1 |
Matous, JV | 1 |
Shustik, C | 1 |
Kastritis, E | 1 |
Treon, SP | 2 |
Li, J | 1 |
Salman, Z | 1 |
Graef, T | 1 |
Buske, C | 1 |
Reda, G | 1 |
Fattizzo, B | 1 |
Cassin, R | 1 |
Mattiello, V | 1 |
Tonella, T | 1 |
Giannarelli, D | 1 |
Massari, F | 1 |
Cortelezzi, A | 1 |
Kapelios, CJ | 1 |
Bonou, MS | 1 |
Diamantopoulos, P | 1 |
Angelopoulou, MK | 1 |
Masoura, C | 1 |
Barbetseas, J | 1 |
Viniou, NA | 1 |
Visentin, A | 1 |
Campello, E | 1 |
Scomazzon, E | 1 |
Spiezia, L | 1 |
Imbergamo, S | 1 |
Pravato, S | 1 |
Piazza, F | 1 |
Semenzato, G | 1 |
Simioni, P | 1 |
Trentin, L | 1 |
Ganatra, S | 1 |
Sharma, A | 1 |
Shah, S | 1 |
Chaudhry, GM | 1 |
Martin, DT | 1 |
Neilan, TG | 1 |
Mahmood, SS | 1 |
Barac, A | 1 |
Groarke, JD | 1 |
Hayek, SS | 1 |
Dani, S | 1 |
Venesy, D | 1 |
Patten, R | 1 |
Nohria, A | 1 |
Stephens, DM | 2 |
Ma, S | 1 |
Caldeira, D | 1 |
Alves, D | 1 |
Costa, J | 1 |
Ferreira, JJ | 1 |
Pinto, FJ | 1 |
Paydas, S | 1 |
Jiang, L | 1 |
Li, L | 1 |
Zuo, S | 1 |
Wu, X | 1 |
Zhao, Q | 1 |
Zhao, X | 1 |
Xia, S | 1 |
Bai, R | 1 |
Du, X | 1 |
Ma, CS | 1 |
Shafaattalab, S | 1 |
Lin, E | 1 |
Christidi, E | 1 |
Huang, H | 1 |
Nartiss, Y | 1 |
Garcia, A | 1 |
Lee, J | 1 |
Protze, S | 1 |
Keller, G | 1 |
Brunham, L | 1 |
Tibbits, GF | 1 |
Laksman, Z | 1 |
Jain, N | 1 |
Keating, M | 1 |
Thompson, P | 1 |
Ferrajoli, A | 1 |
Burger, J | 1 |
Borthakur, G | 1 |
Takahashi, K | 1 |
Estrov, Z | 1 |
Fowler, N | 1 |
Kadia, T | 1 |
Konopleva, M | 1 |
Alvarado, Y | 1 |
Yilmaz, M | 1 |
DiNardo, C | 1 |
Bose, P | 1 |
Ohanian, M | 1 |
Pemmaraju, N | 1 |
Jabbour, E | 1 |
Sasaki, K | 1 |
Kanagal-Shamanna, R | 1 |
Patel, K | 1 |
Jorgensen, J | 1 |
Garg, N | 1 |
Wang, X | 1 |
Sondermann, K | 1 |
Cruz, N | 1 |
Wei, C | 1 |
Ayala, A | 1 |
Plunkett, W | 1 |
Kantarjian, H | 1 |
Gandhi, V | 1 |
Wierda, W | 1 |
Coutre, SE | 1 |
Barrientos, JC | 1 |
Barr, PM | 1 |
Devereux, S | 1 |
Robak, T | 1 |
Kipps, TJ | 1 |
Schuh, A | 1 |
Furman, RR | 1 |
Burger, JA | 1 |
O'Dwyer, M | 1 |
Valentino, R | 1 |
Chang, S | 1 |
Dean, JP | 1 |
James, DF | 1 |
O'Brien, SM | 1 |
Fradley, MG | 1 |
Gliksman, M | 1 |
Emole, J | 1 |
Viganego, F | 1 |
Rhea, I | 1 |
Welter-Frost, A | 1 |
Armanious, M | 1 |
Lee, DH | 1 |
Walko, C | 1 |
Shah, B | 1 |
Chavez, JC | 1 |
McLeod, H | 1 |
Pinilla-Ibarz, J | 1 |
Schabath, MB | 1 |
Ezad, S | 1 |
Khan, AA | 1 |
Cheema, H | 1 |
Ashraf, A | 1 |
Ngo, DTM | 1 |
Sverdlov, AL | 1 |
Collins, NJ | 1 |
McMullen, JR | 1 |
Boey, EJ | 1 |
Ooi, JY | 1 |
Keating, MJ | 2 |
Berglöf, A | 1 |
Hamasy, A | 1 |
Meinke, S | 1 |
Palma, M | 1 |
Krstic, A | 1 |
Månsson, R | 1 |
Kimby, E | 1 |
Österborg, A | 1 |
Smith, CI | 1 |
Wang, ML | 1 |
Lee, H | 1 |
Chuang, H | 1 |
Wagner-Bartak, N | 1 |
Hagemeister, F | 1 |
Westin, J | 1 |
Fayad, L | 1 |
Samaniego, F | 1 |
Turturro, F | 1 |
Oki, Y | 1 |
Chen, W | 1 |
Badillo, M | 1 |
Nomie, K | 1 |
DeLa Rosa, M | 1 |
Zhao, D | 1 |
Lam, L | 1 |
Addison, A | 1 |
Young, KH | 1 |
Li, S | 1 |
Santos, D | 1 |
Medeiros, LJ | 1 |
Champlin, R | 1 |
Romaguera, J | 1 |
Zhang, L | 1 |
Chanan-Khan, A | 1 |
Cramer, P | 1 |
Demirkan, F | 1 |
Silva, RS | 1 |
Grosicki, S | 1 |
Pristupa, A | 1 |
Janssens, A | 1 |
Mayer, J | 1 |
Dilhuydy, MS | 2 |
Pylypenko, H | 1 |
Loscertales, J | 1 |
Avigdor, A | 1 |
Rule, S | 1 |
Villa, D | 1 |
Samoilova, O | 1 |
Panagiotidis, P | 1 |
Goy, A | 1 |
Pavlovsky, MA | 1 |
Karlsson, C | 1 |
Mahler, M | 1 |
Salman, M | 1 |
Sun, S | 1 |
Phelps, C | 1 |
Balasubramanian, S | 1 |
Howes, A | 1 |
Hallek, M | 2 |
Gustine, JN | 1 |
Meid, K | 1 |
Dubeau, TE | 1 |
Castillo, JJ | 1 |
Lee, HJ | 1 |
Chihara, D | 1 |
Wang, M | 1 |
Mouhayar, E | 1 |
Kim, P | 1 |
Leong, DP | 1 |
Caron, F | 1 |
Duan, A | 1 |
Healey, JS | 1 |
Siegal, D | 1 |
Mulligan, SP | 1 |
Ward, CM | 1 |
Whalley, D | 1 |
Hilmer, SN | 1 |
Thompson, PA | 1 |
Lévy, V | 1 |
Al Nawakil, C | 1 |
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Quinquenel, A | 1 |
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Jeyakumar, D | 1 |
O'Brien, S | 1 |
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Acharya, U | 1 |
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Trial | Phase | Enrollment | Study Type | Start Date | Status | ||
---|---|---|---|---|---|---|---|
Evaluation of Reporting of Cardio-vascular Adverse Events With Antineoplastic and Immunomodulating Agents (EROCA)[NCT03530215] | 500,000 participants (Actual) | Observational | 2018-05-02 | Completed | |||
A Randomized Phase III Study of Bendamustine Plus Rituximab Versus Ibrutinib Plus Rituximab Versus Ibrutinib Alone in Untreated Older Patients (>/= 65 Years of Age) With Chronic Lymphocytic Leukemia (CLL)[NCT01886872] | Phase 3 | 547 participants (Actual) | Interventional | 2013-12-09 | Active, not recruiting | ||
Long-term Effect of Chronic Ibrutinib Therapy on Left Atrial Function[NCT03751410] | 40 participants (Actual) | Observational [Patient Registry] | 2018-12-01 | Completed | |||
Phase II Clinical Study of Zanubrutinib Combined With Bendamustine and Rituximab (ZBR) for Time-limited Treatment of Waldenstrom Macroglobulinemia[NCT05914662] | Phase 2 | 30 participants (Anticipated) | Interventional | 2023-02-15 | Recruiting | ||
iNNOVATE Study: A Randomized, Double-Blind, Placebo- Controlled, Phase 3 Study of Ibrutinib or Placebo in Combination With Rituximab in Subjects With Waldenström's Macroglobulinemia[NCT02165397] | Phase 3 | 181 participants (Actual) | Interventional | 2014-07-07 | Completed | ||
Implanted Loop Recorders (ILR) for the Detection and Management of Arrhythmia in Patients Treated With Bruton Tyrosine Kinase (BTK) Inhibitors[NCT05643235] | 50 participants (Anticipated) | Interventional | 2022-11-01 | Recruiting | |||
A Phase II Study of Venetoclax and Ibrutinib in Patients With Chronic Lymphocytic Leukemia (CLL)[NCT02756897] | Phase 2 | 234 participants (Actual) | Interventional | 2016-07-07 | Active, not recruiting | ||
A Long-term Safety Study of Bruton's Tyrosine Kinase (Btk) Inhibitor PCI-32765 in B Cell Lymphoma and Chronic Lymphocytic Leukemia[NCT01109069] | Phase 2 | 199 participants (Actual) | Interventional | 2010-06-30 | Completed | ||
A Phase 1b/2 Fixed-dose Study of Bruton's Tyrosine Kinase (Btk) Inhibitor, PCI-32765, in Chronic Lymphocytic Leukemia[NCT01105247] | Phase 1/Phase 2 | 133 participants (Actual) | Interventional | 2010-05-31 | Completed | ||
A Randomized, Multicenter, Open-label, Phase 3 Study of the Bruton's Tyrosine Kinase (BTK) Inhibitor Ibrutinib (PCI-32765) Versus Ofatumumab in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma[NCT01578707] | Phase 3 | 391 participants (Actual) | Interventional | 2012-06-30 | Completed | ||
An Open-label Extension Study in Patients 65 Years or Older With Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) Who Participated in Study PCYC-1115-CA (Ibrutinib Versus Chlorambucil)[NCT01724346] | Phase 3 | 232 participants (Actual) | Interventional | 2012-08-28 | Completed | ||
Randomized, Multicenter, Open-label, Phase 3 Study of the Bruton's Tyrosine Kinase Inhibitor Ibrutinib Versus Chlorambucil in Patients 65 Years or Older With Treatment-naive Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma[NCT01722487] | Phase 3 | 269 participants (Actual) | Interventional | 2013-03-31 | Completed | ||
A Phase II Study of Ibrutinib Plus Rituximab in Patients With Relapsed/Refractory Mantle Cell Lymphoma or Elderly Patients With Newly Diagnosed MCL[NCT01880567] | Phase 2 | 113 participants (Actual) | Interventional | 2013-07-15 | Active, not recruiting | ||
Randomized, Double-blind, Placebo-controlled Phase 3 Study of Ibrutinib, a Bruton's Tyrosine Kinase (BTK) Inhibitor, in Combination With Bendamustine and Rituximab (BR) in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic[NCT01611090] | Phase 3 | 578 participants (Actual) | Interventional | 2012-09-19 | Completed | ||
Treatment Patterns, Outcomes, and Patient-Reported Health-Related Quality of Life: A Prospective Disease Registry of Patients With Mantle Cell Lymphoma Treated With Novel Agents[NCT03816683] | 229 participants (Actual) | Observational | 2019-04-01 | Active, not recruiting | |||
[information is prepared from clinicaltrials.gov, extracted Sep-2024] |
The Kaplan-Meier method will be used to estimate median DOR. DOR is the time from first objective status to progression or death. CR requires all of the following: absence of lymphadenopathy > 1.5 cm on physical exam/CT scan, no hepatomegaly/splenomegaly on physical exam, no clonal B-cells in the blood, Normal CBC, bone marrow aspirate & biopsy must be normocellular for age. PR requires >= 50% decrease in peripheral lymphocyte count from pre-treatment value, >= 50% reduction in lymphadenopathy, and/or ≥ 50% reduction in splenomegaly/hepatomegaly. CR with exception of having bone marrow lymphoid CLL nodules will be considered a nodular PR (nPR). CR with exception of not having a bone marrow biopsy performed will be considered a clinical CR (CCR). PR with the exception of having less than a 50% reduction in peripheral lymphocyte count will be considered a PR except persistent lymphocytosis (PRL). (NCT01886872)
Timeframe: From the date of first response until progression or death, performed at 2.5 years after the last patient enrolled; up to 4 years.
Intervention | months (Median) |
---|---|
Arm A (Rituximab, Bendamustine Hydrochloride) | 50 |
Arm B (Ibrutinib) | NA |
Arm C (Ibrutinib, Rituximab) | NA |
The Kaplan-Meier method will be used to estimate the rate of overall survival at 2 years in each treatment arm. OS will be measured from the date of registration to the date of the event (i.e., death) or the date of last follow-up to evaluate that event. Patients who are event-free at their last follow-up evaluation will be censored at that time point. (NCT01886872)
Timeframe: From the date of registration to the date of death, assessed up to 2 years
Intervention | percentage of patients (Number) |
---|---|
Arm A (Rituximab, Bendamustine Hydrochloride) | 95 |
Arm B (Ibrutinib) | 90 |
Arm C (Ibrutinib, Rituximab) | 94 |
Complete response (CR) requires all of the following: absence of lymphadenopathy > 1.5 cm on physical exam/CT scan, no hepatomegaly or splenomegaly on physical exam, no clonal B-cells in the blood, Normal CBC, bone marrow aspirate and biopsy must be normocellular for age. Complete response rate and corresponding exact binomial 95% confidence intervals provided. (NCT01886872)
Timeframe: Performed at 2.5 years after the last patient enrolled; up to 4 years.
Intervention | percentage of patients (Number) |
---|---|
Arm A (Rituximab, Bendamustine Hydrochloride) | 26 |
Arm B (Ibrutinib) | 7 |
Arm C (Ibrutinib, Rituximab) | 12 |
Complete response (CR) requires all of the following: absence of lymphadenopathy >1.5 cm on physical exam/CT scan, no hepatomegaly/splenomegaly on physical exam, no clonal B-cells in the blood, Normal CBC, bone marrow aspirate & biopsy must be normocellular for age. Partial response (PR) requires >= 50% decrease in peripheral lymphocyte count from pre-treatment value, >= 50% reduction in lymphadenopathy, and/or ≥ 50% reduction in splenomegaly/hepatomegaly. CR with exception of having bone marrow lymphoid CLL nodules will be considered a nodular PR (nPR). CR with exception of not having a bone marrow biopsy performed will be considered a clinical CR (CCR). PR with the exception of having less than a 50% reduction in peripheral lymphocyte count will be considered a PR except persistent lymphocytosis (PRL).Overall response rate and corresponding exact binomial 95% CI provided. (NCT01886872)
Timeframe: Performed at 2.5 years after the last patient enrolled;up to 4 years.
Intervention | percentage of patients (Number) |
---|---|
Arm A (Rituximab, Bendamustine Hydrochloride) | 75 |
Arm B (Ibrutinib) | 93 |
Arm C (Ibrutinib, Rituximab) | 94 |
Complete response (CR) requires all of the following: absence of lymphadenopathy > 1.5 cm on physical exam/CT scan, no hepatomegaly or splenomegaly on physical exam, no clonal B-cells in the blood, Normal CBC, bone marrow aspirate and biopsy must be normocellular for age. CR with exception of having bone marrow lymphoid CLL nodules will be considered a nodular PR (nPR). CR with exception of not having a bone marrow biopsy performed will be considered a clinical CR (CCR). Response rate and corresponding exact binomial 95% confidence intervals provided. (NCT01886872)
Timeframe: Performed at 2.5 years after the last patient enrolled; up to 4 years.
Intervention | percentage of patients (Number) |
---|---|
Arm A (Rituximab, Bendamustine Hydrochloride) | 33 |
Arm B (Ibrutinib) | 10 |
Arm C (Ibrutinib, Rituximab) | 23 |
Estimated using the number of patients who achieve minimal residual disease divided by the total number randomized to that treatment arm. Corresponding exact binomial 95% confidence intervals for MRD rates will be calculated. (NCT01886872)
Timeframe: Cycle 9 Day 1 Evaluation
Intervention | percentage of patients (Number) |
---|---|
Arm A (Rituximab, Bendamustine Hydrochloride) | 8 |
Arm B (Ibrutinib) | 1 |
Arm C (Ibrutinib, Rituximab) | 4 |
The Kaplan-Meier method will be used to estimate the progression free survival distributions for each arm, with median estimates provided. Progression is defined as any one of the following: an increase in number of blood lymphocytes by >= 50% with >= 5000 B lymphocytes/mL in patients on Arm A or those on Arms 2 or 3 no longer receiving ibrutinib, >= 50% increase in the products of at least 2 lymph nodes on 2 consecutive determination 2 weeks apart, >= 50% increase in the size of the liver/spleen, transformation to a more aggressive histology, progression of any cytopenia (i.e. decrease of Hb levels > 2g/dL). Progression free survival time will be the time to either progression or death whichever occurs first. (NCT01886872)
Timeframe: Time from study entry to the time of documented disease progression or death. The analysis was event driven, performed at 2.5 years after the last patient enrolled;up to 4 years.
Intervention | months (Median) |
---|---|
Arm A (Rituximab, Bendamustine Hydrochloride) | 43 |
Arm B (Ibrutinib) | NA |
Arm C (Ibrutinib, Rituximab) | NA |
The Kaplan-Meier method will be used to estimate the rate of progression free survival at 2 years in each treatment arm. Progression is defined as any one of the following: an increase in number of blood lymphocytes by >= 50%, >= 50% increase in the products of at least 2 lymph nodes on 2 consecutive determination 2 weeks apart, >= 50% increase in the size of the liver/spleen, transformation to a more aggressive histology, progression of any cytopenia (i.e. decrease of Hb levels > 2g/dL). Progression free survival time will be the time to either progression or death whichever occurs first. (NCT01886872)
Timeframe: Time from study entry to the time of documented disease progression or death, assessed up to 2 years
Intervention | percentage of patients (Number) |
---|---|
Arm A (Rituximab, Bendamustine Hydrochloride) | 74 |
Arm B (Ibrutinib) | 87 |
Arm C (Ibrutinib, Rituximab) | 88 |
The rate of grade 3, 4, or 5 treatment-related non-hematologic adverse events (toxicities) by arm; excludes adverse events occurring post-crossover for patients in Arm A (NCT01886872)
Timeframe: Performed at 2.5 years after the last patient enrolled; up to 4 years.
Intervention | percentage of patients (Number) |
---|---|
Arm A (Rituximab, Bendamustine Hydrochloride) | 41 |
Arm B (Ibrutinib) | 48 |
Arm C (Ibrutinib, Rituximab) | 39 |
ORR, defined as the percentage of participants achieving a best overall response of protocol-specified complete response (CR), very good partial response (VGPR), or partial response (PR) per the IRC assessment at or prior to initiation of subsequent antineoplastic therapy and confirmed by 2 consecutive assessments. IRC assessment of response was conducted according to the modified VIth IWWM (NCCN 2014) criteria and incorporated assessments from the central radiology review. CR required complete resolution of lymphadenopathy/splenomegaly if present at baseline. VGPR and PR required reduction in lymphadenopathy/splenomegaly if present at baseline.. Kaplan-Meier estimate. (NCT02165397)
Timeframe: Median time on study: 49.7 months (Ibr+R and Pbo+R) and 57.9 months (Open-Label Ibr)
Intervention | percentage of participants (Number) |
---|---|
Ibrutinib + Rituximab | 76.0 |
Placebo + Rituximab | 30.7 |
Open-Label Substudy: Ibrutinib | 77.4 |
"OS, defined as the time from the date of randomization to the date of death from any cause. All deaths observed as the time of the analysis were considered as events. For participants who were not known to have died at the time of the analysis, OS data were censored at the date last known alive.~As the median OS was not reached in any treatment arm at the time of the analysis, Kaplan Meier point estimates of the OS rate (that is, the estimated percentage of participants still surviving at Month 54) are presented." (NCT02165397)
Timeframe: Month 54 (median time on study: 49.7 months [Ibr+R and Pbo+R] and 57.9 months [Open-Label Ibr])
Intervention | percentage of participants (Number) |
---|---|
Ibrutinib + Rituximab | 86.4 |
Placebo + Rituximab | 84.2 |
Open-Label Substudy: Ibrutinib | 73.4 |
Percentage of participants with ≥ 3 points increase from baseline by Week 25 in the FACIT-Fatigue subscale score.The FACIT-Fatigue is a 13-item questionnaire that assesses participant reported fatigue and its impact upon daily activities and function over the past 7 days. Each of the 13 items of the FACIT-Fatigue Scale ranges from 0-4, with a range of possible total scores from 0 (extreme fatigue) to 52 (no fatigue). Scores below 30 indicate severe fatigue. (NCT02165397)
Timeframe: Baseline, 25 weeks
Intervention | percentage of participants (Number) |
---|---|
Ibrutinib + Rituximab | 68.0 |
Placebo + Rituximab | 54.7 |
Open-Label Substudy: Ibrutinib | 87.1 |
Percentage of participants achieving a sustained improvement in Hgb at or prior to initiation of subsequent antineoplastic therapy. Hgb improvement is defined as an increase of ≥ 2 g/dL over baseline regardless of baseline value, or an increase to >11 g/dL with a ≥0.5 g/dL improvement if baseline is ≤ 11 g/dL. Sustained Hgb improvement is defined as improvement that is sustained continuously for ≥ 56 days (8 weeks) without blood transfusion or growth factors, which includes hemoglobin > 110 g/L with at least a 5 g/L improvement if baseline ≤110 g/L or increase ≥20 g/L over baseline. (NCT02165397)
Timeframe: Median time on study: 49.7 months (Ibr+R and Pbo+R) and 57.9 months (Open-Label Ibr)
Intervention | percentage of participants (Number) |
---|---|
Ibrutinib + Rituximab | 77.3 |
Placebo + Rituximab | 42.7 |
Open-Label Substudy: Ibrutinib | 71.0 |
"PFS was defined as the time from date randomization to date of first IRC-confirmed disease progression (PD) assessed according to the modified VIth International Workshop on Waldenström's Macroglobulinemia (IWWM) criteria (National Comprehensive Cancer Network [NCCN] 2014) or death due to any cause, whichever occurs first, regardless of the use of subsequent antineoplastic therapy prior to documented PD or death.~As the median PFS was not reached in the Ibrutinib + Rituximab arm at the time of the analysis, Kaplan Meier landmark estimate of the PFS rate at 54 months (that is, the estimated percentage of participants with PFS at Month 54) is presented." (NCT02165397)
Timeframe: Month 54 (median time on study: 49.7 months [Ibr+R and Pbo+R] and 57.9 months [Open-Label Ibr])
Intervention | percentage of participants (Number) |
---|---|
Ibrutinib + Rituximab | 68.0 |
Placebo + Rituximab | 25.3 |
Open-Label Substudy: Ibrutinib | 39.7 |
"TTnT was measured from the date of randomization to the start date of any subsequent WM treatment. Participants without subsequent treatment were censored at the date of the last study visit.~As the median TTnT was not reached in the Ibrutinib + Rituximab arm and the Open-Label Substudy arm at the time of the analysis, Kaplan Meier landmark estimate of the TTnT rate at 54 months (that is, the estimated percentage of participants not receiving subsequent WM treatment at Month 54) are presented." (NCT02165397)
Timeframe: Month 54 (median time on study: 49.7 months [Ibr+R and Pbo+R] and 57.9 months [Open-Label Ibr])
Intervention | percentage of participants (Number) |
---|---|
Ibrutinib + Rituximab | 87.4 |
Placebo + Rituximab | 29.4 |
Open-Label Substudy: Ibrutinib | 64.6 |
All death events are due to AE, progressive disease, and other reasons. (NCT01109069)
Timeframe: 30 days after last dose of study drug
Intervention | Participants (Count of Participants) |
---|---|
IBRUTINIB/PCI-32765 | 42 |
Subjects were to receive ibrutinib once daily at the dose level the subject was receiving in the parent study until disease progression or unacceptable toxicity. The study included Screening, Treatment (from the first dose until study drug discontinuation), and Follow-up Phases. (NCT01109069)
Timeframe: 30 days after last dose of study drug, continue up to 6 months
Intervention | Participants (Count of Participants) |
---|---|
A LONG-TERM SAFETY STUDY OF BRUTON'S TYROSINE KINASE (BTK) INH | 199 |
A progressive disease confirmed by a CT scan. (NCT01109069)
Timeframe: 30 days after last dose of study drug, continue up to 6 months
Intervention | Participants (Count of Participants) |
---|---|
IBRUTINIB/PCI-32765 | 70 |
Geometric mean ratio (Fed/Fasted) for PCI-32765 AUClast. The data were collected at 0, 0.5, 1, 2, 4, 6, 24 h post-dose. The AUClast was calculated from 0 up to 24 hours post-dose. (NCT01105247)
Timeframe: Fed was assessed on either Day 8 or Day 15 and Fasted was assessed on the remaining day as cross-over design.
Intervention | (Number) |
---|---|
Food Effect Cohort | 1.65 |
Number of participants who had experienced at least one treatment emergent AEs. (NCT01105247)
Timeframe: From first dose to within 30 days of last dose of PCI-32765
Intervention | Participants (Number) |
---|---|
PCI-32765 | 116 |
Food Effect | 11 |
Response criteria are as outlined in the IWCLL 2008 criteria (Hallek 2008) and as assessed by investigator, e.g. response requires 50% reduction in lymph node size. (NCT01105247)
Timeframe: The median follow-up time for all treated patients are 21 month, range (0.7 month, 29 months).
Intervention | Percentage of Participants (Number) |
---|---|
Treatment Naive | 71 |
Relapsed/ Refractory | 75.3 |
Food Effect | 56.3 |
Criteria for progression are as outlined in the IWCLL 2008 criteria (Hallek 2008) and as assessed by investigator, e.g. progression defined as a 50% increase in lymph node size. (NCT01105247)
Timeframe: The median follow-up time for all treated patients are 21 month, range (0.7 month, 29 months).
Intervention | Percentage of Participants (Number) |
---|---|
Treatment Naive | 96.3 |
Relapsed/ Refractory | 73.6 |
Food- Effect | NA |
OS analysis was conducted at the time of study closure, with no adjustment for crossover from the ofatumumab arm to the ibrutinib arm (NCT01578707)
Timeframe: OS analysis was conducted at the time of study closure, including up to 6 years of study follow-up
Intervention | months (Median) |
---|---|
Ofatumumab (Arm A) | 65.1 |
Ibrutinib (Arm B) | 67.7 |
Overall Response Rate per the IWCLL 2008 criteria as assessed by IRC, limited to the time of primary analysis 06 November 2013 (NCT01578707)
Timeframe: About 18 months after the first subject was enrolled
Intervention | percentage of participants (Number) |
---|---|
Ofatumumab (Arm A) | 4.1 |
Ibrutinib (Arm B) | 42.6 |
Overall response per the IWCLL 2008 criteria as assessed by Investigator with up to 6 years of study follow-up (NCT01578707)
Timeframe: From study initiation to study closure, including up to 6 years of study follow-up
Intervention | percentage of participants (Number) |
---|---|
Ofatumumab (Arm A) | 22.4 |
Ibrutinib (Arm B) | 87.7 |
The primary objective of this study was to evaluate the efficacy of ibrutinib compared to ofatumumab based on independent review committee (IRC) assessment of progression-free survival (PFS) according to 2008 IWCLL guidelines. (NCT01578707)
Timeframe: Analysis was conducted after observing approximately 117 PFS events, which occurred about 18 months after the first subject was enrolled.
Intervention | months (Median) |
---|---|
Ofatumumab (Arm A) | 8.1 |
Ibrutinib (Arm B) | NA |
Long-Term Progression Free Survival as assessed by the investigator with up to 6 years of study follow-up (NCT01578707)
Timeframe: From study initiation to study closure, including up to 6 years of study follow-up
Intervention | months (Median) |
---|---|
Ofatumumab (Arm A) | 8.1 |
Ibrutinib (Arm B) | 44.1 |
Proportion of subjects with hemoglobin (HgB) increase >=20 g/L and platelet (PLT) increase >=50% over baseline continuously for >=56 days without blood transfusions or growth factors. (NCT01578707)
Timeframe: From study initiation to study closure, including up to 6 years of study follow-up
Intervention | percentage of participants (Number) | |
---|---|---|
Hgb Improvement in patient with baseline anemia | Platelet improvement in baseline thrombocytopenia | |
Ibrutinib (Arm B) | 69.7 | 78.4 |
Ofatumumab (Arm A) | 32.6 | 9.4 |
ORR is defined as the proportion of subjects who achieved complete response (CR), complete response with incomplete marrow recovery (CRi), nodule partial response (nPR) or PR per IRC assessment. Response criteria are as outlined in the International Workshop on CLL (iwCLL) 2008 criteria with the 2012 iwCLL modification stating that treatment-related lymphocytosis in the setting of improvement in other parameters was not considered as PD and the 2013 iwCLL clarification of criteria for a partial response to therapy. (NCT01722487)
Timeframe: Analysis was conducted when 15 months had elapsed after the last subject was randomized with the cutoff date of 4 May 2015. The median follow-up time is 18 month.
Intervention | percentage of participants (Number) |
---|---|
Ibrutinib | 82.4 |
Chlorambucil | 35.3 |
OS is calculated for all randomized subjects as the duration of time from the date of randomization to the date of death due to any cause or the date last known alive for subjects who were not known to have died at study closure. (NCT01722487)
Timeframe: Analysis was conducted when 15 months had elapsed after the last subject was randomized with the cutoff date of 4 May 2015. The median follow-up time is 18 month.
Intervention | Months (Median) |
---|---|
Ibrutinib | NA |
Chlorambucil | NA |
"The primary objective of this study was to evaluate the efficacy of Ibrutinib compared with Chlorambucil based on the independent review committee (IRC) assessment of PFS~Progressive disease according to 2008 IWCLL guidelines was defined as:~Group A~Lymphadenopathy, increase ≥50%~Hepatomegaly, increase ≥50%~Splenomegaly, increase ≥50%~Blood lymphocytes, increase ≥ 50% over baseline~Group B~Platelets counts, decrease of ≥ 50% from baseline secondary to CLL~Hemoglobin, decrease of > 2 g/dL from baseline secondary to CLL" (NCT01722487)
Timeframe: Analysis was conducted when 15 months had elapsed after the last subject was randomized with the cutoff date of 4 May 2015. The median follow-up time is 18 month.
Intervention | Months (Median) |
---|---|
Ibrutinib | NA |
Chlorambucil | 18.9 |
The proportion of subjects who achieved Hemoglobin >11 g/dL or increase ≥ 2 g/dL over baseline and persisted continuously for ≥56 days (8 weeks) without blood transfusion or growth factors. (NCT01722487)
Timeframe: Analysis was conducted when 15 months had elapsed after the last subject was randomized with the cutoff date of 4 May 2015. The median follow-up time is 18 month.
Intervention | Percentage of Participants (Number) |
---|---|
Ibrutinib | 45.6 |
Chlorambucil | 20.3 |
In randomized subjects with baseline hemoglobin ≤ 11 g/dL, the proportion of subjects who achieved Hemoglobin >11 g/dL or increase ≥ 2 g/dL over baseline persisted continuously for ≥56 days (8 weeks) without blood transfusion or growth factors. (NCT01722487)
Timeframe: Analysis was conducted when 15 months had elapsed after the last subject was randomized with the cutoff date of 4 May 2015. The median follow-up time is 18 month.
Intervention | Percentage of Participants (Number) |
---|---|
Ibrutinib | 84.3 |
Chlorambucil | 45.5 |
The proportion of subjects who achieved platelet >100 x 10^9/L or increase ≥50% over baseline and persisted continuously for ≥56 days (8 weeks) without blood transfusion or growth factors. (NCT01722487)
Timeframe: Analysis was conducted when 15 months had elapsed after the last subject was randomized with the cutoff date of 4 May 2015. The median follow-up time is 18 month.
Intervention | Percentage of Participants (Number) |
---|---|
Ibrutinib | 27.2 |
Chlorambucil | 11.3 |
In randomized subjects with baseline platelet ≤ 100 x 10^9/L, the proportion of subjects who achieved platelet >100 x 10^9/L or increase ≥50% over baseline persisted continuously for ≥56 days (8 wee without blood transfusion or growth factors. (NCT01722487)
Timeframe: Analysis was conducted when 15 months had elapsed after the last subject was randomized with cutoff date of 4 May 2015. The median follow-up time is 18 month.
Intervention | Percentage of Participants (Number) |
---|---|
Ibrutinib | 77.1 |
Chlorambucil | 42.9 |
Change from baseline in beta2 microglobulin at end of treatment at time of primary analysis was reported. (NCT01611090)
Timeframe: Baseline to EOT (Up to 2 years)
Intervention | milligram per liter (mg/L) (Mean) |
---|---|
Ibrutinib+BR | -0.46 |
Placebo+BR | -0.23 |
"EORTC QLQ-C30 Physical Functioning Score is a questionnaire to assess quality of life of cancer patients. It is composed of 30 items, multi-item measure (28 items) and 2 single-item measures. For the multiple item measure, 4-point scale is used and the score for each item range from 1 = not at all to 4 = very much. Higher scores indicate worsening. The 2 single-item measure involves question about the overall health and overall quality of life which was rated on a 7-point scale ranging from 1 = very poor to 7 = excellent. Lower scores indicate worsening. All scale and item scores were linearly transformed to be in range from 0-100. A higher score represents a higher (better) level of functioning, or a higher (worse) level of symptoms." (NCT01611090)
Timeframe: Baseline to EOT (up to 2 years)
Intervention | Units on a scale (Mean) |
---|---|
Ibrutinib+BR | -2.1 |
Placebo+BR | -4.1 |
The EuroQol-5 is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=extreme problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1. High score indicating a high level of utility. (NCT01611090)
Timeframe: Baseline to EOT (up to 2 years)
Intervention | Units on a scale (Mean) |
---|---|
Ibrutinib+BR | 0.0 |
Placebo+BR | 0.0 |
The EQ-5D questionnaire is a brief, generic health-related quality of life assessment (HRQOL) that can also be used to incorporate participant preferences into health economic evaluations. The EQ-5D questionnaire assesses HRQOL in terms of degree of limitation on 5 health dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) and as overall health using a visual analog scale with response options ranging from 0 (worst imaginable health) to 100 (best imaginable health). (NCT01611090)
Timeframe: Baseline to EOT (up to 2 years)
Intervention | Units on a scale (Mean) |
---|---|
Ibrutinib+BR | -4.3 |
Placebo+BR | 4.0 |
FACIT-Fatigue is an instrument for use as a measure of the effect of fatigue in patients with cancer and other chronic diseases. Responses to the 13-item FACIT Fatigue Scale are reported on a 5-point categorical response scale ranging from 0 (not at all) to 4 (very much). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worst score) to 52 (best score). (NCT01611090)
Timeframe: Baseline to EOT (up to 2 years)
Intervention | Units on a scale (Mean) |
---|---|
Ibrutinib+BR | -0.9 |
Placebo+BR | 0.0 |
Time to improvement is defined as the time interval (months) from randomization to the first observation of improvement. FACIT-Fatigue is an instrument for use as a measure of the effect of fatigue in patients with cancer and other chronic diseases. Responses to the 13-item FACIT Fatigue Scale are reported on a 5-point categorical response scale ranging from 0 (not at all) to 4 (very much). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worst score) to 52 (best score). (NCT01611090)
Timeframe: Up to 2 years
Intervention | Months (Number) |
---|---|
Ibrutinib+BR | 6.5 |
Placebo+BR | 4.6 |
Number of participants who received subsequent antineoplastic therapy was reported. (NCT01611090)
Timeframe: Up to 5 years
Intervention | Participants (Count of Participants) |
---|---|
Ibrutinib+BR | 52 |
Placebo+BR | 61 |
The disease-related symptoms included fatigue, weight loss, fevers, night sweats, abdominal discomfort/splenomegaly and anorexia. (NCT01611090)
Timeframe: From the date of randomization to disease progression (Up to 2 years)
Intervention | Participants (Count of Participants) |
---|---|
Ibrutinib+BR | 0 |
Placebo+BR | 0 |
ORR defined as number of participants achieving a complete response (CR), complete response with incomplete marrow recovery (CRi), nodular partial response (nPR) or partial response (PR). IWCLL 2008 criteria: CR- No lymphadenopathy and hepatosplenomegaly, no constitutional symptoms, neutrophils >1.5*10^9/liter (L), platelets >100*10^9/L, Hgb >11 gram per deciliter (g/dL) and absolute lymphocyte count <4000/microliter (mcL); CRi- CR with incomplete recovery of bone marrow; nPR- participants meet criteria for CR, but the bone marrow biopsy shows B-lymphoid nodules, may represent a clonal infiltrate; PR-2 of the following when abnormal at baseline: >=50% decrease in ALC, >=50% decrease in sum products of up to 6 lymph nodes, >=50% decrease in enlargement of spleen or liver; and 1 of the following: neutrophils >1.5*10^9/L, Platelets >100*10^9/L and Hgb>11 g/dL or >=50% improvement over baseline in any of these; no new enlarged nodes or new hepatosplenomegaly. (NCT01611090)
Timeframe: Up to 5 years
Intervention | Percentage of participants (Number) |
---|---|
Ibrutinib+BR | 87.2 |
Placebo+BR | 66.1 |
OS was defined as the interval between the date of randomization and the date of death from any cause. (NCT01611090)
Timeframe: Up to 5 years
Intervention | Months (Median) |
---|---|
Ibrutinib+BR | NA |
Placebo+BR | NA |
MRD-negative response was defined as the percentage of participants who reach MRD negative disease status (less than 1 chronic lymphocytic leukemia [CLL] cell per 10,000 leukocytes) in either bone marrow or peripheral blood. All randomized participants were included in this analysis. Participants with missing MRD data were considered non-responders. (NCT01611090)
Timeframe: Up to 5 years
Intervention | Percentage of participants (Number) |
---|---|
Ibrutinib+BR | 28.7 |
Placebo+BR | 5.9 |
PFS was defined as the interval between the date of randomization and the date of disease progression or death, whichever was first reported. IWCLL 2008 criteria for PD: New enlarged nodes >1.5 cm, new hepatomegaly or splenomegaly, or other new organ infiltrates, bone lesion, ascites, or pleural effusion confirmed due to chronic lymphocytic leukemia (CLL); >=50% increase in existing lymph nodes; >=50% increase in enlargement of liver or spleen; >=50% increase from baseline in lymphocyte count (and to >=5*10^9/L) or >=50% increase from nadir count confirmed on >=2 serial assessments if absolute lymphocyte count (ALC) >=30,000 per microliter and lymphocyte doubling time is rapid, unless considered treatment-related lymphocytosis; new cytopenia (Hemoglobin b [Hgb] or platelets) attributable to CLL; and transformation to a more aggressive histology. (NCT01611090)
Timeframe: Up to 5 years
Intervention | Months (Median) |
---|---|
Ibrutinib+BR | 65.12 |
Placebo+BR | 14.32 |
The EORTC QLQ-CLL 16 is a 16-item disease specific module that comprises 5 domains of patient-reported health status important in CLL. There are three multi-item scales that include fatigue (2 items), treatment side effects and disease symptoms (8 items), and infection (4 items), and 2 single-item scales on social activities and future health worries. Responses are measured on a 4 point scale ranging from 1 (not at all) to 4 (very much). (NCT01611090)
Timeframe: Baseline to EOT (up to 2 years)
Intervention | Units on the scale (Mean) | |||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Lost weight | Dry mouth | Bruises | Abdominal discomfort | Temperature going up and down | Night sweats | Skin problems | Feel ill | Feel lethargic | Felt slowed down | Limited in planning activities | Worried about health in the future | Trouble with chest infections | Trouble with other infections | Repeated courses of antibiotics | Worried about picking up infection | |
Ibrutinib+BR | 0.1 | 0.3 | 0.1 | 0.1 | 0.1 | -0.6 | 0.4 | 0.1 | 0.1 | 0.3 | 0.2 | 0.0 | 0.2 | 0.7 | 0.9 | 0.3 |
Placebo+BR | 0.0 | 0.1 | 0.0 | 0.0 | 0.0 | -0.3 | 0.3 | 0.2 | 0.0 | 0.0 | 0.1 | 0.0 | 0.0 | 0.1 | 0.0 | 0.2 |
Sustained hematologic improvement was defined as hematological improvement that was sustained continuously for greater than or equal to (>=) 56 days without blood transfusion or growth factors: 1) Platelet counts greater than (>)100* 109/liter (L) if baseline less than or equal to (<=) 100*109/L or increase >= 50 percent (%) over baseline; 2) Hemoglobin >11 gram per deciliters (g/dL) if baseline <= 11 g/dL or increase >= 2 g/dL over baseline. (NCT01611090)
Timeframe: Up to 5 years
Intervention | Percentage of Participants (Number) | |
---|---|---|
Hemoglobin | Platelets | |
Ibrutinib+BR | 36.7 | 30.8 |
Placebo+BR | 29.1 | 21.8 |
21 reviews available for adenine and Atrial Fibrillation
Article | Year |
---|---|
An oral drug for chronic lymphocytic leukemia.
Topics: Adenine; Administration, Oral; Antineoplastic Agents; Atrial Fibrillation; Hemorrhage; Humans; Hyper | 2020 |
Evolution in the management of chronic lymphocytic leukemia in Japan: should MRD negativity be the goal?
Topics: Adenine; Antineoplastic Combined Chemotherapy Protocols; Atrial Fibrillation; Bridged Bicyclo Compou | 2020 |
Zanubrutinib for the treatment of Waldenström Macroglobulinemia.
Topics: Adenine; Agammaglobulinaemia Tyrosine Kinase; Antineoplastic Agents; Atrial Fibrillation; Benzamides | 2020 |
Risk of bleeding complications and atrial fibrillation associated with ibrutinib treatment: A systematic review and meta-analysis.
Topics: Adenine; Atrial Fibrillation; Humans; Piperidines; Pyrazoles; Pyrimidines; Retrospective Studies | 2021 |
Bruton's tyrosine kinase Inhibitors and Cardiotoxicity: More Than Just Atrial Fibrillation.
Topics: Adenine; Agammaglobulinaemia Tyrosine Kinase; Atrial Fibrillation; Cardiotoxicity; Heart Failure; He | 2021 |
Practical recommendations for the choice of anticoagulants in the management of patients with atrial fibrillation on ibrutinib.
Topics: Adenine; Anticoagulants; Antineoplastic Agents; Atrial Fibrillation; Disease Management; Drug Intera | 2017 |
Current Status of Bruton's Tyrosine Kinase Inhibitor Development and Use in B-Cell Malignancies.
Topics: Adenine; Agammaglobulinaemia Tyrosine Kinase; Atrial Fibrillation; Drug Discovery; Graft vs Host Dis | 2017 |
Atrial fibrillation as a complication of ibrutinib therapy: clinical features and challenges of management.
Topics: Adenine; Anticoagulants; Antineoplastic Agents; Atrial Fibrillation; Clinical Trials as Topic; Disea | 2018 |
Cardiac side effects of bruton tyrosine kinase (BTK) inhibitors.
Topics: Adenine; Agammaglobulinaemia Tyrosine Kinase; Anticoagulants; Antineoplastic Agents; Atrial Fibrilla | 2018 |
How I treat CLL patients with ibrutinib.
Topics: Adenine; Aged; Aged, 80 and over; Atrial Fibrillation; Autoimmunity; Communicable Diseases; Disease | 2018 |
Optimising outcomes for patients with chronic lymphocytic leukaemia on ibrutinib therapy: European recommendations for clinical practice.
Topics: Adenine; Anticoagulants; Antineoplastic Agents; Arthralgia; Atrial Fibrillation; Diabetes Mellitus, | 2018 |
Practical management of ibrutinib in the real life: Focus on atrial fibrillation and bleeding.
Topics: Adenine; Anti-Arrhythmia Agents; Anticoagulants; Atrial Fibrillation; Clinical Trials as Topic; Hema | 2018 |
Monitoring and Management of Toxicities of Novel B Cell Signaling Agents.
Topics: Adenine; Antineoplastic Agents; Atrial Fibrillation; B-Lymphocytes; Bridged Bicyclo Compounds, Heter | 2018 |
Ibrutinib-Associated Atrial Fibrillation.
Topics: Adenine; Adult; Aged; Aged, 80 and over; Antineoplastic Agents; Atrial Fibrillation; Female; Humans; | 2018 |
How I manage ibrutinib intolerance and complications in patients with chronic lymphocytic leukemia.
Topics: Adenine; Aged; Anti-Infective Agents; Anticoagulants; Arthralgia; Atrial Fibrillation; Drug Resistan | 2019 |
Ibrutinib increases the risk of hypertension and atrial fibrillation: Systematic review and meta-analysis.
Topics: Adenine; Atrial Fibrillation; Databases, Factual; Humans; Hypertension; Leukemia, Lymphocytic, Chron | 2019 |
Management of adverse effects/toxicity of ibrutinib.
Topics: Adenine; Agammaglobulinaemia Tyrosine Kinase; Atrial Fibrillation; Drug-Related Side Effects and Adv | 2019 |
Targets for Ibrutinib Beyond B Cell Malignancies.
Topics: Adenine; Agammaglobulinaemia Tyrosine Kinase; Animals; Atrial Fibrillation; Humans; Leukemia, Lympho | 2015 |
The risk of atrial fibrillation with ibrutinib use: a systematic review and meta-analysis.
Topics: Adenine; Agammaglobulinaemia Tyrosine Kinase; Animals; Atrial Fibrillation; Humans; Incidence; Leuke | 2016 |
B cell receptor inhibition as a target for CLL therapy.
Topics: Adenine; Agammaglobulinaemia Tyrosine Kinase; Age Factors; Atrial Fibrillation; Diarrhea; Hemorrhage | 2016 |
Risk of Atrial Fibrillation and Bleeding Diathesis Associated With Ibrutinib Treatment: A Systematic Review and Pooled Analysis of Four Randomized Controlled Trials.
Topics: Adenine; Adult; Aged; Aged, 80 and over; Antibodies, Monoclonal; Atrial Fibrillation; Disease Suscep | 2017 |
8 trials available for adenine and Atrial Fibrillation
Article | Year |
---|---|
Adverse event burden in older patients with CLL receiving bendamustine plus rituximab or ibrutinib regimens: Alliance A041202.
Topics: Adenine; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Atrial Fibrillatio | 2021 |
Phase 3 Trial of Ibrutinib plus Rituximab in Waldenström's Macroglobulinemia.
Topics: Adenine; Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Atrial Fibr | 2018 |
Phase 3 Trial of Ibrutinib plus Rituximab in Waldenström's Macroglobulinemia.
Topics: Adenine; Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Atrial Fibr | 2018 |
Phase 3 Trial of Ibrutinib plus Rituximab in Waldenström's Macroglobulinemia.
Topics: Adenine; Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Atrial Fibr | 2018 |
Phase 3 Trial of Ibrutinib plus Rituximab in Waldenström's Macroglobulinemia.
Topics: Adenine; Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Atrial Fibr | 2018 |
Ibrutinib and Venetoclax for First-Line Treatment of CLL.
Topics: Adenine; Administration, Oral; Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy | 2019 |
Long-term safety of single-agent ibrutinib in patients with chronic lymphocytic leukemia in 3 pivotal studies.
Topics: Adenine; Adult; Aged; Aged, 80 and over; Anemia; Atrial Fibrillation; Diarrhea; Drug Tolerance; Fati | 2019 |
Long-term safety of single-agent ibrutinib in patients with chronic lymphocytic leukemia in 3 pivotal studies.
Topics: Adenine; Adult; Aged; Aged, 80 and over; Anemia; Atrial Fibrillation; Diarrhea; Drug Tolerance; Fati | 2019 |
Long-term safety of single-agent ibrutinib in patients with chronic lymphocytic leukemia in 3 pivotal studies.
Topics: Adenine; Adult; Aged; Aged, 80 and over; Anemia; Atrial Fibrillation; Diarrhea; Drug Tolerance; Fati | 2019 |
Long-term safety of single-agent ibrutinib in patients with chronic lymphocytic leukemia in 3 pivotal studies.
Topics: Adenine; Adult; Aged; Aged, 80 and over; Anemia; Atrial Fibrillation; Diarrhea; Drug Tolerance; Fati | 2019 |
Long-term safety of single-agent ibrutinib in patients with chronic lymphocytic leukemia in 3 pivotal studies.
Topics: Adenine; Adult; Aged; Aged, 80 and over; Anemia; Atrial Fibrillation; Diarrhea; Drug Tolerance; Fati | 2019 |
Long-term safety of single-agent ibrutinib in patients with chronic lymphocytic leukemia in 3 pivotal studies.
Topics: Adenine; Adult; Aged; Aged, 80 and over; Anemia; Atrial Fibrillation; Diarrhea; Drug Tolerance; Fati | 2019 |
Long-term safety of single-agent ibrutinib in patients with chronic lymphocytic leukemia in 3 pivotal studies.
Topics: Adenine; Adult; Aged; Aged, 80 and over; Anemia; Atrial Fibrillation; Diarrhea; Drug Tolerance; Fati | 2019 |
Long-term safety of single-agent ibrutinib in patients with chronic lymphocytic leukemia in 3 pivotal studies.
Topics: Adenine; Adult; Aged; Aged, 80 and over; Anemia; Atrial Fibrillation; Diarrhea; Drug Tolerance; Fati | 2019 |
Long-term safety of single-agent ibrutinib in patients with chronic lymphocytic leukemia in 3 pivotal studies.
Topics: Adenine; Adult; Aged; Aged, 80 and over; Anemia; Atrial Fibrillation; Diarrhea; Drug Tolerance; Fati | 2019 |
Long-term safety of single-agent ibrutinib in patients with chronic lymphocytic leukemia in 3 pivotal studies.
Topics: Adenine; Adult; Aged; Aged, 80 and over; Anemia; Atrial Fibrillation; Diarrhea; Drug Tolerance; Fati | 2019 |
Long-term safety of single-agent ibrutinib in patients with chronic lymphocytic leukemia in 3 pivotal studies.
Topics: Adenine; Adult; Aged; Aged, 80 and over; Anemia; Atrial Fibrillation; Diarrhea; Drug Tolerance; Fati | 2019 |
Long-term safety of single-agent ibrutinib in patients with chronic lymphocytic leukemia in 3 pivotal studies.
Topics: Adenine; Adult; Aged; Aged, 80 and over; Anemia; Atrial Fibrillation; Diarrhea; Drug Tolerance; Fati | 2019 |
Long-term safety of single-agent ibrutinib in patients with chronic lymphocytic leukemia in 3 pivotal studies.
Topics: Adenine; Adult; Aged; Aged, 80 and over; Anemia; Atrial Fibrillation; Diarrhea; Drug Tolerance; Fati | 2019 |
Long-term safety of single-agent ibrutinib in patients with chronic lymphocytic leukemia in 3 pivotal studies.
Topics: Adenine; Adult; Aged; Aged, 80 and over; Anemia; Atrial Fibrillation; Diarrhea; Drug Tolerance; Fati | 2019 |
Long-term safety of single-agent ibrutinib in patients with chronic lymphocytic leukemia in 3 pivotal studies.
Topics: Adenine; Adult; Aged; Aged, 80 and over; Anemia; Atrial Fibrillation; Diarrhea; Drug Tolerance; Fati | 2019 |
Long-term safety of single-agent ibrutinib in patients with chronic lymphocytic leukemia in 3 pivotal studies.
Topics: Adenine; Adult; Aged; Aged, 80 and over; Anemia; Atrial Fibrillation; Diarrhea; Drug Tolerance; Fati | 2019 |
Long-term safety of single-agent ibrutinib in patients with chronic lymphocytic leukemia in 3 pivotal studies.
Topics: Adenine; Adult; Aged; Aged, 80 and over; Anemia; Atrial Fibrillation; Diarrhea; Drug Tolerance; Fati | 2019 |
Long-term safety of single-agent ibrutinib in patients with chronic lymphocytic leukemia in 3 pivotal studies.
Topics: Adenine; Adult; Aged; Aged, 80 and over; Anemia; Atrial Fibrillation; Diarrhea; Drug Tolerance; Fati | 2019 |
Long-term safety of single-agent ibrutinib in patients with chronic lymphocytic leukemia in 3 pivotal studies.
Topics: Adenine; Adult; Aged; Aged, 80 and over; Anemia; Atrial Fibrillation; Diarrhea; Drug Tolerance; Fati | 2019 |
Long-term safety of single-agent ibrutinib in patients with chronic lymphocytic leukemia in 3 pivotal studies.
Topics: Adenine; Adult; Aged; Aged, 80 and over; Anemia; Atrial Fibrillation; Diarrhea; Drug Tolerance; Fati | 2019 |
Long-term safety of single-agent ibrutinib in patients with chronic lymphocytic leukemia in 3 pivotal studies.
Topics: Adenine; Adult; Aged; Aged, 80 and over; Anemia; Atrial Fibrillation; Diarrhea; Drug Tolerance; Fati | 2019 |
Long-term safety of single-agent ibrutinib in patients with chronic lymphocytic leukemia in 3 pivotal studies.
Topics: Adenine; Adult; Aged; Aged, 80 and over; Anemia; Atrial Fibrillation; Diarrhea; Drug Tolerance; Fati | 2019 |
Long-term safety of single-agent ibrutinib in patients with chronic lymphocytic leukemia in 3 pivotal studies.
Topics: Adenine; Adult; Aged; Aged, 80 and over; Anemia; Atrial Fibrillation; Diarrhea; Drug Tolerance; Fati | 2019 |
Long-term safety of single-agent ibrutinib in patients with chronic lymphocytic leukemia in 3 pivotal studies.
Topics: Adenine; Adult; Aged; Aged, 80 and over; Anemia; Atrial Fibrillation; Diarrhea; Drug Tolerance; Fati | 2019 |
Long-term safety of single-agent ibrutinib in patients with chronic lymphocytic leukemia in 3 pivotal studies.
Topics: Adenine; Adult; Aged; Aged, 80 and over; Anemia; Atrial Fibrillation; Diarrhea; Drug Tolerance; Fati | 2019 |
Ibrutinib-related atrial fibrillation: A single center Australian experience.
Topics: Adenine; Aged; Aged, 80 and over; Atrial Fibrillation; Australia; Female; Hematologic Neoplasms; Hos | 2019 |
Ibrutinib in combination with rituximab in relapsed or refractory mantle cell lymphoma: a single-centre, open-label, phase 2 trial.
Topics: Adenine; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Atrial Fibrillatio | 2016 |
Ibrutinib combined with bendamustine and rituximab compared with placebo, bendamustine, and rituximab for previously treated chronic lymphocytic leukaemia or small lymphocytic lymphoma (HELIOS): a randomised, double-blind, phase 3 study.
Topics: Adenine; Adult; Aged; Aged, 80 and over; Anemia; Antineoplastic Combined Chemotherapy Protocols; Atr | 2016 |
Atrial fibrillation associated with ibrutinib in Waldenström macroglobulinemia.
Topics: Adenine; Adult; Aged; Aged, 80 and over; Atrial Fibrillation; Female; Humans; Male; Middle Aged; Pip | 2016 |
31 other studies available for adenine and Atrial Fibrillation
Article | Year |
---|---|
Distinct Effects of Ibrutinib and Acalabrutinib on Mouse Atrial and Sinoatrial Node Electrophysiology and Arrhythmogenesis.
Topics: Action Potentials; Adenine; Animals; Arrhythmias, Cardiac; Atrial Fibrillation; Benzamides; Cardiac | 2021 |
Determinants of Atrial Fibrillation Development among Patients undergoing Ibrutinib Therapy.
Topics: Adenine; Atrial Fibrillation; Case-Control Studies; Heart Failure; Humans; Piperidines; Risk Factors | 2022 |
Recommendations for ibrutinib treatment in patients with atrial fibrillation and/or elevated cardiovascular risk.
Topics: Adenine; Atrial Fibrillation; Cardiovascular Diseases; Humans; Piperidines; Pyrazoles; Pyrimidines; | 2020 |
Enhanced cardiomyocyte reactive oxygen species signaling promotes ibrutinib-induced atrial fibrillation.
Topics: Acetophenones; Adenine; Animals; Atrial Fibrillation; Calcium; Calcium-Calmodulin-Dependent Protein | 2020 |
Assessment of dabigatran plasma concentration may improve the safety of anticoagulation in patients treated with ibrutinib with concomitant atrial fibrillation.
Topics: Adenine; Anticoagulants; Atrial Fibrillation; Dabigatran; Humans; Piperidines; Plasma; Stroke; Treat | 2020 |
Atrial fibrillation in patients with chronic lymphocytic leukemia (CLL) treated with ibrutinib: risk prediction, management, and clinical outcomes.
Topics: Adenine; Adult; Aged; Aged, 80 and over; Atrial Fibrillation; Disease Management; Female; Follow-Up | 2021 |
Ibrutinib-Mediated Atrial Fibrillation Attributable to Inhibition of C-Terminal Src Kinase.
Topics: Action Potentials; Adenine; Agammaglobulinaemia Tyrosine Kinase; Animals; Antineoplastic Agents; Atr | 2020 |
Chemotherapy and atrial fibrillation.
Topics: Adenine; Atrial Fibrillation; Australia; Humans; Piperidines; Pyrazoles; Pyrimidines | 2020 |
Dabigatran in ibrutinib-treated patients with atrial fibrillation and chronic lymphocytic leukemia: experience of three cases.
Topics: Adenine; Agammaglobulinaemia Tyrosine Kinase; Aged; Antithrombins; Atrial Fibrillation; Dabigatran; | 2021 |
Cardio-Oncology: A Win-Win Situation: How Solving the Mystery of an Ibrutinib Off-Target Effect Reveals New Insights Into Atrial Fibrillation Mechanisms.
Topics: Adenine; Atrial Fibrillation; Humans; Neoplasms; Piperidines; Pyrazoles; Pyrimidines | 2020 |
Utilizing left atrial strain to identify patients at risk for atrial fibrillation on ibrutinib.
Topics: Adenine; Atrial Fibrillation; Heart Atria; Humans; Piperidines; Retrospective Studies; Risk Assessme | 2021 |
Ibrutinib in patients with atrial fibrillation - the challenge of thromboembolic prophylaxis.
Topics: Adenine; Anticoagulants; Antineoplastic Agents; Atrial Fibrillation; Hematologic Neoplasms; Hemorrha | 2021 |
Concomitant Treatment with Ibrutinib and Amiodarone Causing Reversible Heart Failure Syndrome.
Topics: Adenine; Aged; Amiodarone; Atrial Fibrillation; Cytochrome P-450 CYP3A Inhibitors; Drug Interactions | 2016 |
Analysis of Efficacy and Tolerability of Bruton Tyrosine Kinase Inhibitor Ibrutinib in Various B-cell Malignancies in the General Community: A Single-center Experience.
Topics: Adenine; Agammaglobulinaemia Tyrosine Kinase; Aged; Aged, 80 and over; Atrial Fibrillation; B-Lympho | 2017 |
Left atrial abnormality (LAA) as a predictor of ibrutinib-associated atrial fibrillation in patients with chronic lymphocytic leukemia.
Topics: Adenine; Aged; Antineoplastic Agents; Atrial Fibrillation; Case-Control Studies; Electrocardiography | 2018 |
Increased Susceptibility for Atrial and Ventricular Cardiac Arrhythmias in Mice Treated With a Single High Dose of Ibrutinib.
Topics: Adenine; Animals; Atrial Fibrillation; Disease Models, Animal; Disease Susceptibility; Dose-Response | 2018 |
Predictors of atrial fibrillation in ibrutinib-treated CLL patients: a prospective study.
Topics: Adenine; Agammaglobulinaemia Tyrosine Kinase; Aged; Aged, 80 and over; Atrial Fibrillation; Echocard | 2018 |
Ibrutinib-related atrial fibrillation: Therapeutic challenges.
Topics: Adenine; Amiodarone; Anti-Arrhythmia Agents; Atrial Fibrillation; Humans; Male; Middle Aged; Piperid | 2019 |
Dabigatran in ibrutinib-treated patients with atrial fibrillation and lymphoproliferative diseases: Experience of 4 cases.
Topics: Adenine; Aged; Aged, 80 and over; Atrial Fibrillation; Dabigatran; Female; Humans; Lymphoproliferati | 2018 |
Risk factors for the development of atrial fibrillation on ibrutinib treatment.
Topics: Adenine; Aged; Atrial Fibrillation; Comorbidity; Electrocardiography; Female; Heart Failure; Humans; | 2019 |
Ibrutinib promotes atrial fibrillation by inducing structural remodeling and calcium dysregulation in the atrium.
Topics: Adenine; Agammaglobulinaemia Tyrosine Kinase; Animals; Antineoplastic Agents; Atrial Fibrillation; A | 2019 |
Ibrutinib Displays Atrial-Specific Toxicity in Human Stem Cell-Derived Cardiomyocytes.
Topics: Adenine; Atrial Fibrillation; Cardiotoxicity; Cell Differentiation; Cells, Cultured; Heart; Heart At | 2019 |
Rates and Risk of Atrial Arrhythmias in Patients Treated With Ibrutinib Compared With Cytotoxic Chemotherapy.
Topics: Adenine; Age Factors; Aged; Angiotensin Receptor Antagonists; Angiotensin-Converting Enzyme Inhibito | 2019 |
Ibrutinib increases the risk of atrial fibrillation, potentially through inhibition of cardiac PI3K-Akt signaling.
Topics: Adenine; Agammaglobulinaemia Tyrosine Kinase; Animals; Animals, Newborn; Atrial Fibrillation; Gene E | 2014 |
Ibrutinib-related atrial fibrillation in patients with mantle cell lymphoma.
Topics: Adenine; Aged; Aged, 80 and over; Atrial Fibrillation; Female; Follow-Up Studies; Humans; Incidence; | 2016 |
Atrial fibrillation, anticoagulant stroke prophylaxis and bleeding risk with ibrutinib therapy for chronic lymphocytic leukaemia and lymphoproliferative disorders.
Topics: Adenine; Anticoagulants; Atrial Fibrillation; Humans; Leukemia, Lymphocytic, Chronic, B-Cell; Piperi | 2016 |
Atrial fibrillation in CLL patients treated with ibrutinib. An international retrospective study.
Topics: Adenine; Aged; Aged, 80 and over; Antineoplastic Agents; Atrial Fibrillation; Disease Management; Fe | 2016 |
Proposed Algorithm for Managing Ibrutinib-Related Atrial Fibrillation.
Topics: Adenine; Algorithms; Antineoplastic Agents; Atrial Fibrillation; Humans; Piperidines; Pyrazoles; Pyr | 2016 |
Atrial fibrillation in patients with chronic lymphocytic leukemia (CLL).
Topics: Adenine; Adult; Aged; Aged, 80 and over; Atrial Fibrillation; Comorbidity; Female; Humans; Incidence | 2017 |
The association of beta-fibrinogen 455 G/A gene polymorphism with left atrial thrombus and severe spontaneous echo contrast in atrial fibrillation.
Topics: Adenine; Aged; Atrial Fibrillation; Coronary Thrombosis; Cross-Sectional Studies; Diabetes Complicat | 2010 |
Interleukin 6 G-174C polymorphism influences outcome following coronary revascularization surgery.
Topics: Adenine; Aged; Alleles; Atrial Fibrillation; Blood Loss, Surgical; Coronary Artery Bypass; Coronary | 2005 |