adenine has been researched along with Graft vs Host Disease in 35 studies
Graft vs Host Disease: The clinical entity characterized by anorexia, diarrhea, loss of hair, leukopenia, thrombocytopenia, growth retardation, and eventual death brought about by the GRAFT VS HOST REACTION.
| Excerpt | Relevance | Reference |
|---|---|---|
| " To understand the ability of irradiation regulations to prevent transfusion of inferior units, we irradiated 980 RCC in saline-adenine-glucose-mannitol (SAGM) using various combinations of pre-irradiation age and post-irradiation storage times, and measured hemolysis and extracellular potassium levels." | 3.80 | The effect of timing of gamma-irradiation on hemolysis and potassium release in leukoreduced red cell concentrates stored in SAGM. ( Acker, JP; Chen, D; Devine, DV; Hansen, AL; Kurach, JD; Levin, E; Serrano, K; Turner, TR, 2014) |
| "Myositis is a known complication of chronic graft-vs-host disease (cGVHD) following allogeneic haematopoietic stem cell transplantation, but can be difficult to diagnose and manage." | 1.62 | A case of inflammatory myopathy in graft vs host disease - A potential role for ibrutinib. ( Limaye, V; Wilkinson, M; Yeung, D, 2021) |
| "Moreover, treatment of bronchiolitis obliterans syndrome demonstrates heterogeneity in applied therapeutic options and sequence because of a lack of controlled data and different conclusions from already existing evidence." | 1.51 | Changes in Immunosuppressive Treatment of Chronic Graft-versus-Host Disease: Comparison of 2 Surveys within Allogeneic Hematopoietic Stem Cell Transplant Centers in Germany, Austria, and Switzerland. ( Ayuk, F; Ditschkowski, M; Gerbitz, A; Greinix, H; Halter, J; Hilgendorf, I; Holler, E; Jedlickova, Z; Klein, S; Kobbe, G; Lawitschka, A; Middeke, JM; Schäfer-Eckart, K; Stadler, M; Stelljes, M; Wagner-Drouet, E; Winkler, J; Wolff, D; Zeiser, R, 2019) |
| Timeframe | Studies, this research(%) | All Research% |
|---|---|---|
| pre-1990 | 0 (0.00) | 18.7374 |
| 1990's | 3 (8.57) | 18.2507 |
| 2000's | 4 (11.43) | 29.6817 |
| 2010's | 20 (57.14) | 24.3611 |
| 2020's | 8 (22.86) | 2.80 |
| Authors | Studies |
|---|---|
| Chin, KK | 1 |
| Kim, HT | 1 |
| Inyang, EA | 1 |
| Ho, V | 1 |
| Koreth, J | 2 |
| Romee, R | 1 |
| Gooptu, M | 1 |
| Shapiro, R | 1 |
| Antin, J | 1 |
| Soiffer, R | 1 |
| Jaglowski, S | 5 |
| Pidala, J | 3 |
| Cutler, C | 3 |
| Trando, A | 1 |
| Dunn-Pirio, A | 1 |
| Koura, D | 1 |
| Goodman, AM | 1 |
| King-Kallimanis, BL | 1 |
| Wroblewski, T | 1 |
| Kwitkowski, V | 1 |
| De Claro, RA | 1 |
| Gwise, T | 1 |
| Bhatnagar, V | 1 |
| Farrell, AT | 1 |
| Kluetz, PG | 1 |
| Gonzalez, RM | 1 |
| Limaye, S | 1 |
| Limaye, V | 2 |
| Kaloyannidis, P | 1 |
| Ayyad, A | 1 |
| Bahaliwah, Z | 1 |
| Blowi, B | 1 |
| Alanazi, W | 1 |
| Al Shammasi, Z | 1 |
| Elsoudi, H | 1 |
| Ibrahim, I | 1 |
| Al Hashmi, H | 1 |
| Doki, N | 1 |
| Toyosaki, M | 1 |
| Shiratori, S | 1 |
| Osumi, T | 1 |
| Okada, M | 1 |
| Kawakita, T | 1 |
| Sawa, M | 1 |
| Ishikawa, T | 1 |
| Ueda, Y | 1 |
| Yoshinari, N | 1 |
| Nakahara, S | 1 |
| Wilkinson, M | 1 |
| Yeung, D | 1 |
| Aw, A | 1 |
| Brown, JR | 2 |
| Krämer, I | 1 |
| Stilgenbauer, S | 2 |
| Dietrich, S | 2 |
| Böttcher, S | 1 |
| Zeis, M | 1 |
| Stadler, M | 2 |
| Bittenbring, J | 1 |
| Uharek, L | 1 |
| Scheid, C | 2 |
| Hegenbart, U | 1 |
| Ho, A | 1 |
| Hallek, M | 1 |
| Kneba, M | 1 |
| Schmitz, N | 1 |
| Döhner, H | 1 |
| Dreger, P | 2 |
| Miklos, D | 2 |
| Cutler, CS | 1 |
| Arora, M | 2 |
| Waller, EK | 2 |
| Jagasia, M | 1 |
| Pusic, I | 2 |
| Flowers, ME | 1 |
| Logan, AC | 4 |
| Nakamura, R | 2 |
| Blazar, BR | 3 |
| Li, Y | 1 |
| Chang, S | 2 |
| Lal, I | 1 |
| Dubovsky, J | 1 |
| James, DF | 1 |
| Styles, L | 3 |
| Aschenbrenner, DS | 1 |
| Michallet, M | 1 |
| Bosman, P | 1 |
| Sobh, M | 1 |
| Boumendil, A | 1 |
| Nagler, A | 1 |
| Cornelissen, J | 1 |
| Niederwieser, D | 1 |
| Müller, L | 1 |
| Vandenberghe, E | 1 |
| Scortechini, I | 1 |
| Schoemans, H | 1 |
| Andersen, NS | 1 |
| Finke, J | 1 |
| Russo, D | 1 |
| Ljungman, P | 1 |
| Passweg, J | 1 |
| van Gelder, M | 1 |
| Durakovic, N | 1 |
| Labussiere-Wallet, H | 1 |
| Berg, T | 1 |
| Wulf, G | 1 |
| Bethge, W | 1 |
| Bunjes, D | 1 |
| Canepari, ME | 1 |
| Schaap, M | 1 |
| Fox, CP | 1 |
| Kröger, N | 1 |
| Montoto, S | 1 |
| Schetelig, J | 1 |
| Rahmat, LT | 1 |
| Jaglowski, SM | 1 |
| Arney, K | 1 |
| Wolff, D | 1 |
| Hilgendorf, I | 2 |
| Wagner-Drouet, E | 1 |
| Jedlickova, Z | 1 |
| Ayuk, F | 1 |
| Zeiser, R | 1 |
| Schäfer-Eckart, K | 1 |
| Gerbitz, A | 1 |
| Klein, S | 1 |
| Middeke, JM | 1 |
| Lawitschka, A | 1 |
| Winkler, J | 1 |
| Halter, J | 1 |
| Holler, E | 1 |
| Kobbe, G | 1 |
| Stelljes, M | 1 |
| Ditschkowski, M | 1 |
| Greinix, H | 1 |
| Jagasia, MH | 1 |
| Flowers, MED | 1 |
| Clow, F | 2 |
| Lal, ID | 1 |
| El Kenz, H | 1 |
| Corazza, F | 1 |
| Van Der Linden, P | 1 |
| Chabab, S | 1 |
| Vandenvelde, C | 1 |
| Serrano, K | 1 |
| Chen, D | 1 |
| Hansen, AL | 1 |
| Levin, E | 1 |
| Turner, TR | 1 |
| Kurach, JD | 1 |
| Acker, JP | 1 |
| Devine, DV | 1 |
| Dubovsky, JA | 1 |
| Flynn, R | 1 |
| Du, J | 1 |
| Harrington, BK | 1 |
| Zhong, Y | 1 |
| Kaffenberger, B | 1 |
| Yang, C | 1 |
| Towns, WH | 1 |
| Lehman, A | 1 |
| Johnson, AJ | 1 |
| Muthusamy, N | 1 |
| Devine, SM | 1 |
| Serody, JS | 1 |
| Murphy, WJ | 1 |
| Munn, DH | 1 |
| Luznik, L | 1 |
| Hill, GR | 1 |
| Wong, HK | 1 |
| MacDonald, KK | 1 |
| Maillard, I | 1 |
| Elias, L | 1 |
| Soiffer, RJ | 1 |
| Antin, JH | 1 |
| Ritz, J | 1 |
| Panoskaltsis-Mortari, A | 1 |
| Byrd, JC | 2 |
| Rozovski, U | 1 |
| Benjamini, O | 1 |
| Jain, P | 1 |
| Thompson, PA | 1 |
| Wierda, WG | 1 |
| O'Brien, S | 2 |
| Burger, JA | 1 |
| Ferrajoli, A | 1 |
| Faderl, S | 1 |
| Shpall, E | 1 |
| Hosing, C | 1 |
| Khouri, IF | 1 |
| Champlin, R | 1 |
| Keating, MJ | 2 |
| Estrov, Z | 1 |
| Schutt, SD | 1 |
| Fu, J | 1 |
| Nguyen, H | 1 |
| Bastian, D | 1 |
| Heinrichs, J | 1 |
| Wu, Y | 1 |
| Liu, C | 1 |
| McDonald, DG | 1 |
| Yu, XZ | 1 |
| Ryan, CE | 1 |
| Sahaf, B | 1 |
| Hillmen, P | 1 |
| Dyer, MJ | 1 |
| Mato, AR | 1 |
| Rezvani, AR | 1 |
| Coutre, SE | 1 |
| Miklos, DB | 1 |
| Smith, LL | 1 |
| Amarnath, S | 1 |
| Flomerfelt, FA | 1 |
| Costanzo, CM | 1 |
| Foley, JE | 1 |
| Mariotti, J | 1 |
| Konecki, DM | 1 |
| Gangopadhyay, A | 1 |
| Eckhaus, M | 1 |
| Wong, S | 1 |
| Levine, BL | 1 |
| June, CH | 1 |
| Fowler, DH | 1 |
| Loebermann, M | 1 |
| Borchert, K | 1 |
| Junghanss, C | 1 |
| Freund, M | 1 |
| Schmitt, M | 1 |
| Resende, RG | 1 |
| Correia-Silva, JD | 1 |
| Silva, TA | 1 |
| Xavier, SG | 1 |
| Bittencourt, H | 1 |
| Gomez, RS | 1 |
| Abreu, MH | 1 |
| Janatpour, K | 1 |
| Denning, L | 1 |
| Nelson, K | 1 |
| Betlach, B | 1 |
| Mackenzie, M | 1 |
| Holland, P | 1 |
| Góes, EG | 1 |
| Borges, JC | 1 |
| Covas, DT | 1 |
| Orellana, MD | 1 |
| Palma, PV | 1 |
| Morais, FR | 1 |
| Pelá, CA | 1 |
| Kren, V | 2 |
| Otová, B | 3 |
| Elleder, D | 2 |
| Elleder, M | 2 |
| Panczak, A | 3 |
| Sladká, M | 2 |
| Holý, A | 2 |
| Kohoutová, M | 1 |
| Blazek, K | 1 |
| Schramlová, J | 1 |
| Kita, T | 1 |
| Nei, J | 1 |
| Matsu, T | 1 |
| Yoshiba, H | 1 |
| Matsuda, T | 1 |
| Yahagi, H | 1 |
| Uchida, S | 1 |
| Nakao, S | 1 |
| Suzuki, Y | 1 |
| Tateishi, N | 1 |
| Cicha, I | 1 |
| Shiba, M | 1 |
| Muraoka, M | 1 |
| Tadokoro, K | 1 |
| Maeda, N | 1 |
| Trial | Phase | Enrollment | Study Type | Start Date | Status | ||
|---|---|---|---|---|---|---|---|
| A Phase 3 Study of the Bruton's Tyrosine Kinase (BTK) Inhibitor Ibrutinib in Subjects With Steroid Dependent/Refractory Chronic Graft Versus Host Disease (cGVHD)[NCT03474679] | Phase 3 | 19 participants (Actual) | Interventional | 2018-05-01 | Completed | ||
| A Multicenter Open-Label Phase 1b/2 Study of Ibrutinib in Steroid Dependent or Refractory Chronic Graft Versus Host Disease[NCT02195869] | Phase 1/Phase 2 | 45 participants (Actual) | Interventional | 2014-07-14 | Completed | ||
| Pilot Study on Allogeneic Stem Cell Transplantation Following Conditioning With Fludarabine and an Alkylating Agent in Patients With High-Risk Chronic Lymphocytic Leukemia[NCT00281983] | Phase 1/Phase 2 | 100 participants (Actual) | Interventional | 2000-06-30 | Completed | ||
| Combination Ibrutinib and Rituximab for the Treatment of Chronic Graft-Versus-Host Disease Following Allogeneic Stem Cell Transplant[NCT03689894] | Phase 1/Phase 2 | 2 participants (Actual) | Interventional | 2019-04-11 | Terminated (stopped due to Insufficient accrual) | ||
| Efficacy and Safety of the Combination of Low-dose Ibrutinib and Itraconazole in Moderate to Severe Chronic Graft Versus Host Disease: a Phase 2 Trial[NCT05348096] | Phase 2 | 13 participants (Anticipated) | Interventional | 2022-04-01 | Recruiting | ||
| [information is prepared from clinicaltrials.gov, extracted Sep-2024] | |||||||
DOR is defined as the duration from the date of initial response (CR or PR) to the date of progressive cGVHD or death, whichever occurred first. CR is defined as resolution of all manifestations in each organ or site; PR is defined as improvement in at least 1 organ or site without progression in any other organ or site; and cGVHD progression is defined as clinically meaningful worsening in 1 or more organs regardless of improvement in other organs. (NCT03474679)
Timeframe: Up to 3 year 6 months
| Intervention | Months (Median) |
|---|---|
| Ibrutinib 420 mg | NA |
An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. TEAEs are adverse events with onset during the treatment phase or that were a consequence of a preexisting condition that has worsened since baseline, and occurred during treatment or within 30 days following the last dose of study treatment, or any adverse event that was considered study treatment-related regardless of the start date of the event. (NCT03474679)
Timeframe: Up to 3 year 6 months
| Intervention | Participants (Count of Participants) |
|---|---|
| Ibrutinib 420 mg | 19 |
ORR is defined as the percentage of participants who achieve complete response (CR) or partial response (PR) in the absence of new therapy for chronic graft versus host disease (cGVHD) and absence of progression of underlying disease or death based on the National Institutes of Health (NIH) Consensus Development Project Criteria (2014). CR is defined as resolution of all manifestations in each organ or site; PR is defined as improvement in at least 1 organ or site without progression in any other organ or site; and chronic graft versus host disease (cGVHD) progression is defined as clinically meaningful worsening in 1 or more organs regardless of improvement in other organs. (NCT03474679)
Timeframe: Up to 3 year 6 months
| Intervention | Percentage of participants (Number) |
|---|---|
| Ibrutinib 420 mg | 84.2 |
Percentage of participants with overall improvement in Lee cGVHD symptom scale score was reported. Lee cGVHD symptom scale is a patient-reported symptom scale used to measure symptom burden and has 7 subscales (Skin, Eyes and Mouth, Breathing, Eating and Digestion, Muscles and Joints, Energy, and Mental and Emotional) with ratings as follows: 0-Not at all, 1-Slightly, 2-Moderately, 3-Quite a bit, 4-Extremely, with lower values representing a better outcome. A score was calculated for each subscale by taking the mean of all items completed if more than 50% were answered and normalizing to a 0 to 100 with a higher score indicating worse symptoms. An overall score was calculated as the average of these 7 subscales if at least 4 subscales had valid scores. A change of greater than or equal to (>=) 7 points on the Lee cGVHD symptom scale overall score was considered significant and relates to improvement in quality of life (QoL). (NCT03474679)
Timeframe: Up to 3 year 6 months
| Intervention | Percentage of participants (Number) |
|---|---|
| Ibrutinib 420 mg | 52.6 |
Sustained response rate was defined as percentage of participants with NIH defined CR or PR that was sustained for at least 20 weeks. CR is defined as resolution of all manifestations in each organ or site; PR is defined as improvement in at least 1 organ or site without progression in any other organ or site. (NCT03474679)
Timeframe: Up to 3 year 6 months
| Intervention | Percentage of participants (Number) |
|---|---|
| Ibrutinib 420 mg | 68.8 |
CL/F is defined as apparent clearance of ibrutinib. (NCT03474679)
Timeframe: Day 1 of Weeks 1 and 2
| Intervention | Milliliters per hour (mL/h) (Mean) | |
|---|---|---|
| Week 1: Day 1 | Week 2: Day 1 | |
| Ibrutinib 420 mg | 194211 | 162457 |
CL/F is defined as apparent clearance of PCI-45227. (NCT03474679)
Timeframe: Day 1 of Weeks 1 and 2
| Intervention | mL/h (Mean) | |
|---|---|---|
| Week 1: Day 1 | Week 2: Day 1 | |
| Ibrutinib 420 mg | 251681 | 111922 |
Vd/F is defined as apparent volume of distribution of ibrutinib. (NCT03474679)
Timeframe: Day 1 of Weeks 1 and 2
| Intervention | Milliliters (mL) (Mean) |
|---|---|
| Week 1: Day 1 | |
| Ibrutinib 420 mg | 1350160 |
Vd/F is defined as apparent volume of distribution of PCI-45227. (NCT03474679)
Timeframe: Day 1 of Weeks 1 and 2
| Intervention | mL (Mean) |
|---|---|
| Week 1: Day 1 | |
| Ibrutinib 420 mg | 2148283 |
AUC(0-24) is defined as area under the plasma concentration-time curve from time zero to 24 hours of ibrutinib. (NCT03474679)
Timeframe: 0 to 24 hours (Day 1 of Weeks 1 and 2)
| Intervention | hour*ng/mL (Mean) | |
|---|---|---|
| Week 1: Day 1 | Week 2: Day 1 | |
| Ibrutinib 420 mg | 2929.3 | 4035.6 |
AUC(0-24) is defined as area under the plasma concentration-time curve from time zero to 24 hours of PCI-45227. (NCT03474679)
Timeframe: 0 to 24 hours (Day 1 of Weeks 1 and 2)
| Intervention | hour*ng/mL (Mean) | |
|---|---|---|
| Week 1: Day 1 | Week 2: Day 1 | |
| Ibrutinib 420 mg | 1803.0 | 2547.6 |
AUC(0-infinity) is defined as area under the plasma concentration-time curve from time zero to infinite time of ibrutinib. (NCT03474679)
Timeframe: Day 1 of Weeks 1 and 2
| Intervention | hour*ng/mL (Mean) | |
|---|---|---|
| Week 1: Day 1 | Week 2: Day 1 | |
| Ibrutinib 420 mg | 2643.8 | 2659.2 |
AUC(0-infinity) is defined as area under the plasma concentration-time curve from time zero to infinite time of PCI-45227. (NCT03474679)
Timeframe: Day 1 of Weeks 1 and 2
| Intervention | hour*ng/mL (Mean) | |
|---|---|---|
| Week 1: Day 1 | Week 2: Day 1 | |
| Ibrutinib 420 mg | 1766.1 | 3752.6 |
AUC(0-last) is defined as area under the plasma concentration-time curve from time zero to time of last measurable concentration of ibrutinib. (NCT03474679)
Timeframe: Day 1 of Weeks 1 and 2
| Intervention | hours*nanograms per milliliter (h*ng/mL) (Mean) | |
|---|---|---|
| Week 1: Day 1 | Week 2: Day 1 | |
| Ibrutinib 420 mg | 3683.7 | 4024.8 |
AUC(0-last) is defined as area under the plasma concentration-time curve from time zero to time of last measurable concentration of PCI-45227. (NCT03474679)
Timeframe: Day 1 of Weeks 1 and 2
| Intervention | h*ng/mL (Mean) | |
|---|---|---|
| Week 1: Day 1 | Week 2: Day 1 | |
| Ibrutinib 420 mg | 1976.9 | 2547.6 |
cGVHD response rate was defined as percentage of participants with NIH defined CR or PR at each timepoint. CR is defined as resolution of all manifestations in each organ or site; PR is defined as improvement in at least 1 organ or site without progression in any other organ or site. (NCT03474679)
Timeframe: Weeks 5, 13, 25, 37, 49, 61, 73, 85, 97, 109, 121, 133, 145, 157
| Intervention | Percentage of participants (Number) | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Week 5 | Week 13 | Week 25 | Week 37 | Week 49 | Week 61 | Week 73 | Week 85 | Week 97 | Week 109 | Week 121 | Week 133 | Week 145 | Week 157 | |
| Ibrutinib 420 mg | 26.3 | 42.1 | 52.6 | 47.4 | 47.4 | 42.1 | 36.8 | 31.6 | 31.6 | 31.6 | 36.8 | 31.6 | 26.3 | 10.5 |
Change in the amount of corticosteroid required over time was reported. (NCT03474679)
Timeframe: Baseline, Weeks 24, 48, 96, and 144
| Intervention | Milligrams per kilograms per day (Median) | ||||
|---|---|---|---|---|---|
| Baseline | Week 24 | Week 48 | Week 96 | Week 144 | |
| Ibrutinib 420 mg | 0.270 | 0.250 | 0.150 | 0.140 | 0.140 |
T1/2 is defined as elimination half-life of ibrutinib. (NCT03474679)
Timeframe: Day 1 of Weeks 1 and 2
| Intervention | Hours (Median) | |
|---|---|---|
| Week 1: Day 1 | Week 2: Day 1 | |
| Ibrutinib 420 mg | 4.9 | 4.4 |
T1/2 is defined as elimination half-life of PCI-45227. (NCT03474679)
Timeframe: Day 1 of Weeks 1 and 2
| Intervention | Hours (Median) | |
|---|---|---|
| Week 1: Day 1 | Week 2: Day 1 | |
| Ibrutinib 420 mg | 5.9 | 5.4 |
Cmax is defined as maximum observed plasma concentration of ibrutinib. (NCT03474679)
Timeframe: Day 1 of Weeks 1 and 2
| Intervention | Nanograms per milliliter (ng/mL) (Mean) | |
|---|---|---|
| Week 1: Day 1 | Week 2: Day 1 | |
| Ibrutinib 420 mg | 490.45 | 478.01 |
Cmax is defined as maximum observed plasma concentration of PCI-45227. (NCT03474679)
Timeframe: Day 1 of Weeks 1 and 2
| Intervention | ng/mL (Mean) | |
|---|---|---|
| Week 1: Day 1 | Week 2: Day 1 | |
| Ibrutinib 420 mg | 185.37 | 203.16 |
Tmax is defined as time to reach the maximum observed plasma concentration of ibrutinib. (NCT03474679)
Timeframe: Day 1 of Weeks 1 and 2
| Intervention | Hours (Median) | |
|---|---|---|
| Week 1: Day 1 | Week 2: Day 1 | |
| Ibrutinib 420 mg | 3.87 | 4.02 |
Tmax is defined as time to reach the maximum observed plasma concentration of PCI-45227. (NCT03474679)
Timeframe: Day 1 of Weeks 1 and 2
| Intervention | Hours (Median) | |
|---|---|---|
| Week 1: Day 1 | Week 2: Day 1 | |
| Ibrutinib 420 mg | 4.00 | 4.02 |
"Subject reported improvement in symptom burden. The symptom burden will be measured according to the Lee cGVHD Symptom Scale. A change in >7 points on the Lee cGVHD Symptom Scale will be considered significant and relates to improvement in quality of life.~A score is calculated for each subscale by taking the mean of all items completed if more than 50% were answered and normalizing to a 0 to 100 scale. A total summary score is calculated as the average of these 7 subscales if at least 4 subscales have valid scores.~There are 7 subscales (Skin, Energy, Lung, Eye, Nutrition, Mouth and Psychological) with ratings as follow: 0- Not at all, 1- Slightly, 2 Moderately, 3 Quite a bit, 4-Extremely; with a lower values representing a better outcome." (NCT02195869)
Timeframe: Analysis was conducted with the data extraction date of 15 Sep 2017, with a median follow-up time of 25.56 months.
| Intervention | percentage of participants (Number) |
|---|---|
| Phase 1b/Phase 2 | 42.9 |
Number of participants with dose-limiting toxicities as a measure of safety profile to determine recommended dose of ibrutinib (NCT02195869)
Timeframe: 28 treatment days after last subject enrolled in Phase 1 dose level(s).
| Intervention | Participants (Count of Participants) |
|---|---|
| Phase 1b: Dose Level 1 | 0 |
Overall Response Rate is defined as the proportion of subjects who achieved complete response (CR) or partial response (PR). Response criteria are based on NIH cGVHD Response assessment (Pavletic 2006; Measurement of Therapeutic Response, ASBMT Web site). (NCT02195869)
Timeframe: Analysis was conducted with the data extraction date of 15 Sep 2017, with a median follow-up time of 25.56 months.
| Intervention | percentage of participants (Number) |
|---|---|
| Phase1b/Phase 2 | 69 |
Number of Participants With Adverse Events as a Measure of Safety and Tolerability of Ibrutinib (NCT02195869)
Timeframe: From first dose with study drug until 30 days after the last dose of study drug, up to 36.7 months
| Intervention | Participants (Count of Participants) |
|---|---|
| Phase 1b/Phase 2 | 42 |
For subjects who achieved an NIH-defined CR or PR, the proportion of subjects who achieved CR or PR that was sustained for at least 20 weeks (140 days). Intermittent SD was also acceptable. (NCT02195869)
Timeframe: Analysis was conducted with the data extraction date of 15 Sep 2017, with a median follow-up time of 25.56 months.
| Intervention | percentage of participants (Number) |
|---|---|
| Phase1b/Phase 2 | 69 |
For subjects who achieved an NIH-defined CR or PR, the interval between the date of initial documentation of a response and the date of first documented evidence of PD, death, or date of censoring if applicable. (NCT02195869)
Timeframe: Analysis was conducted with the data extraction date of 15 Sep 2017, with a median follow-up time of 25.56 months.
| Intervention | Median (Median) |
|---|---|
| Phase1b/Phase 2 | NA |
Average daily corticosteroid dose assessed each week. (NCT02195869)
Timeframe: Analysis was conducted with the data extraction date of 15 Sep 2017, with a median follow-up time of 25.56 months.
| Intervention | Daily Dose of Steroid by Weight (mg/kg/d (Median) | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Week 1 | Week 2 | Week 3 | Week 4 | Week 5 | Week 6 | Week 7 | Week 8 | Week 9 | Week 10 | Week 11 | Week 12 | Week 13 | Week 14 | Week 15 | Week 16 | Week 17 | Week 18 | Week 19 | Week 20 | Week 21 | Week 22 | Week 23 | Week 24 | Week 25 | Week 26 | Week 27 | Week 28 | Week 29 | Week 30 | Week 31 | Week 32 | Week 33 | Week 34 | Week 35 | Week 36 | Week 37 | Week 38 | Week 39 | Week 40 | Week 41 | Week 42 | Week 43 | Week 44 | Week 45 | Week 46 | Week 47 | Week 48 | Week 49 | Week 50 | Week 51 | Week 52 | Week 53 | Week 54 | Week 55 | Week 56 | Week 57 | Week 58 | Week 59 | Week 60 | Week 61 | Week 62 | Week 63 | Week 64 | Week 65 | Week 66 | Week 67 | Week 68 | Week 69 | Week 70 | Week 71 | Week 72 | Week 73 | Week 74 | Week 75 | Week 76 | Week 77 | Week 78 | Week 79 | Week 80 | Week 81 | Week 82 | Week 83 | Week 84 | Week 85 | Week 86 | Week 87 | Week 88 | Week 89 | Week 90 | Week 91 | Week 92 | Week 93 | Week 94 | Week 95 | Week 96 | Week 97 | Week 98 | Week 99 | Week 100 | Week 101 | Week 102 | Week 103 | Week 104 | Week 105 | Week 106 | Week 107 | Week 108 | Week 109 | Week 110 | Week 111 | Week 112 | Week 113 | Week 114 | Week 115 | Week 116 | Week 117 | Week 118 | Week 119 | Week 120 | Week 121 | Week 122 | Week 123 | Week 124 | Week 125 | Week 126 | Week 127 | Week 128 | Week 129 | Week 130 | Week 131 | Week 132 | Week 133 | Week 134 | Week 135 | Week 136 | Week 137 | Week 138 | Week 139 | Week 140 | Week 141 | Week 142 | Week 143 | Week 144 | Week 145 | Week 146 | Week 147 | Week 148 | Week 149 | Week 150 | Week 151 | Week 152 | Week 153 | Week 154 | Week 155 | Week 156 | Week 157 | Week 158 | Week 159 | Week 160 | |
| Phase 1b/Phase 2 | 0.31 | 0.32 | 0.32 | 0.31 | 0.31 | 0.30 | 0.30 | 0.30 | 0.27 | 0.25 | 0.25 | 0.25 | 0.24 | 0.23 | 0.23 | 0.23 | 0.21 | 0.20 | 0.20 | 0.21 | 0.22 | 0.22 | 0.22 | 0.21 | 0.19 | 0.18 | 0.18 | 0.18 | 0.16 | 0.16 | 0.16 | 0.18 | 0.17 | 0.17 | 0.18 | 0.18 | 0.16 | 0.15 | 0.15 | 0.15 | 0.15 | 0.15 | 0.13 | 0.13 | 0.13 | 0.13 | 0.13 | 0.13 | 0.12 | 0.10 | 0.10 | 0.10 | 0.10 | 0.10 | 0.10 | 0.10 | 0.10 | 0.10 | 0.10 | 0.08 | 0.08 | 0.08 | 0.08 | 0.08 | 0.08 | 0.08 | 0.08 | 0.08 | 0.08 | 0.08 | 0.07 | 0.08 | 0.08 | 0.07 | 0.07 | 0.07 | 0.07 | 0.07 | 0.07 | 0.07 | 0.07 | 0.07 | 0.07 | 0.07 | 0.08 | 0.08 | 0.08 | 0.08 | 0.08 | 0.08 | 0.08 | 0.08 | 0.08 | 0.08 | 0.08 | 0.08 | 0.08 | 0.08 | 0.08 | 0.08 | 0.09 | 0.09 | 0.09 | 0.09 | 0.08 | 0.08 | 0.08 | 0.08 | 0.08 | 0.08 | 0.08 | 0.08 | 0.08 | 0.08 | 0.12 | 0.12 | 0.08 | 0.08 | 0.08 | 0.08 | 0.08 | 0.12 | 0.08 | 0.08 | 0.08 | 0.08 | 0.08 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.06 | 0.06 | 0.06 |
Response rate of clinically significant GVHD will be assessed using NIH criteria (from 2014 NIH Consensus Development Project). (NCT03689894)
Timeframe: 6 weeks, 3 months, and 6 months after initiation of treatment
| Intervention | Participants (Count of Participants) |
|---|---|
| Ibrutinib Plus Rituximab | 0 |
5 reviews available for adenine and Graft vs Host Disease
| Article | Year |
|---|---|
Evolving Therapeutic Options for Chronic Graft-versus-Host Disease.
Topics: Adenine; Adrenal Cortex Hormones; Chronic Disease; Cyclophosphamide; Graft vs Host Disease; Hematopo | 2020 |
Clinical Characteristics of Myositis Associated with Graft-Versus-Host Disease.
Topics: Adenine; Chronic Disease; Graft vs Host Disease; Hematopoietic Stem Cell Transplantation; Humans; My | 2021 |
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 |
Ibrutinib for the treatment of patients with chronic graft-versus-host disease after failure of one or more lines of systemic therapy.
Topics: Adenine; Animals; Chronic Disease; Drug Interactions; Graft vs Host Disease; Humans; Piperidines; Py | 2018 |
How ibrutinib, a B-cell malignancy drug, became an FDA-approved second-line therapy for steroid-resistant chronic GVHD.
Topics: Adenine; Animals; B-Lymphocytes; Chronic Disease; Drug Approval; Drug Resistance; Graft vs Host Dise | 2018 |
6 trials available for adenine and Graft vs Host Disease
| Article | Year |
|---|---|
An Open-Label, Single-Arm, Multicenter Study of Ibrutinib in Japanese Patients With Steroid-dependent/Refractory Chronic Graft-Versus-Host Disease.
Topics: Adenine; Adolescent; Chronic Disease; Graft vs Host Disease; Humans; Japan; Piperidines; Pyrazoles; | 2021 |
An Open-Label, Single-Arm, Multicenter Study of Ibrutinib in Japanese Patients With Steroid-dependent/Refractory Chronic Graft-Versus-Host Disease.
Topics: Adenine; Adolescent; Chronic Disease; Graft vs Host Disease; Humans; Japan; Piperidines; Pyrazoles; | 2021 |
An Open-Label, Single-Arm, Multicenter Study of Ibrutinib in Japanese Patients With Steroid-dependent/Refractory Chronic Graft-Versus-Host Disease.
Topics: Adenine; Adolescent; Chronic Disease; Graft vs Host Disease; Humans; Japan; Piperidines; Pyrazoles; | 2021 |
An Open-Label, Single-Arm, Multicenter Study of Ibrutinib in Japanese Patients With Steroid-dependent/Refractory Chronic Graft-Versus-Host Disease.
Topics: Adenine; Adolescent; Chronic Disease; Graft vs Host Disease; Humans; Japan; Piperidines; Pyrazoles; | 2021 |
Allogeneic hematopoietic cell transplantation for high-risk CLL: 10-year follow-up of the GCLLSG CLL3X trial.
Topics: Adenine; Adult; Aged; Alemtuzumab; Allografts; Antineoplastic Agents, Immunological; Combined Modali | 2017 |
Ibrutinib for chronic graft-versus-host disease after failure of prior therapy.
Topics: Adenine; Adrenal Cortex Hormones; Adult; Agammaglobulinaemia Tyrosine Kinase; Aged; Biomarkers; Chro | 2017 |
Ibrutinib for chronic graft-versus-host disease after failure of prior therapy.
Topics: Adenine; Adrenal Cortex Hormones; Adult; Agammaglobulinaemia Tyrosine Kinase; Aged; Biomarkers; Chro | 2017 |
Ibrutinib for chronic graft-versus-host disease after failure of prior therapy.
Topics: Adenine; Adrenal Cortex Hormones; Adult; Agammaglobulinaemia Tyrosine Kinase; Aged; Biomarkers; Chro | 2017 |
Ibrutinib for chronic graft-versus-host disease after failure of prior therapy.
Topics: Adenine; Adrenal Cortex Hormones; Adult; Agammaglobulinaemia Tyrosine Kinase; Aged; Biomarkers; Chro | 2017 |
Ibrutinib for bridging to allogeneic hematopoietic cell transplantation in patients with chronic lymphocytic leukemia or mantle cell lymphoma: a study by the EBMT Chronic Malignancies and Lymphoma Working Parties.
Topics: Adenine; Adult; Aged; Allografts; Disease-Free Survival; Female; Graft vs Host Disease; Hematopoieti | 2019 |
Ibrutinib for Chronic Graft-versus-Host Disease After Failure of Prior Therapy: 1-Year Update of a Phase 1b/2 Study.
Topics: Adenine; Chronic Disease; Female; Graft vs Host Disease; Humans; Male; Piperidines; Pyrazoles; Pyrim | 2019 |
Ibrutinib for Chronic Graft-versus-Host Disease After Failure of Prior Therapy: 1-Year Update of a Phase 1b/2 Study.
Topics: Adenine; Chronic Disease; Female; Graft vs Host Disease; Humans; Male; Piperidines; Pyrazoles; Pyrim | 2019 |
Ibrutinib for Chronic Graft-versus-Host Disease After Failure of Prior Therapy: 1-Year Update of a Phase 1b/2 Study.
Topics: Adenine; Chronic Disease; Female; Graft vs Host Disease; Humans; Male; Piperidines; Pyrazoles; Pyrim | 2019 |
Ibrutinib for Chronic Graft-versus-Host Disease After Failure of Prior Therapy: 1-Year Update of a Phase 1b/2 Study.
Topics: Adenine; Chronic Disease; Female; Graft vs Host Disease; Humans; Male; Piperidines; Pyrazoles; Pyrim | 2019 |
Ibrutinib efficacy and tolerability in patients with relapsed chronic lymphocytic leukemia following allogeneic HCT.
Topics: Adenine; Adult; Aged; B-Lymphocytes; Chimerism; Cohort Studies; Female; Germinal Center; Graft vs Ho | 2016 |
24 other studies available for adenine and Graft vs Host Disease
| Article | Year |
|---|---|
Ibrutinib in Steroid-Refractory Chronic Graft-versus-Host Disease, a Single-Center Experience.
Topics: Adenine; Graft vs Host Disease; Humans; Piperidines; Retrospective Studies; Steroids | 2021 |
First use of ibrutinib for the treatment of post-transplant central nervous system graft-versus-host disease.
Topics: Adenine; Graft vs Host Disease; Hematopoietic Stem Cell Transplantation; Humans; Piperidines | 2023 |
FDA review summary of patient-reported outcome results for ibrutinib in the treatment of chronic graft versus host disease.
Topics: Adenine; Adult; Aged; Female; Graft vs Host Disease; Humans; Male; Middle Aged; Patient Reported Out | 2020 |
Ibrutinib for steroid refractory chronic graft-versus-host disease: therapeutic efficiency can be limited by increased risk of fungal infection.
Topics: Adenine; Chronic Disease; Graft vs Host Disease; Hematopoietic Stem Cell Transplantation; Humans; My | 2021 |
A case of inflammatory myopathy in graft vs host disease - A potential role for ibrutinib.
Topics: Adenine; Biopsy; Graft vs Host Disease; Hematopoietic Stem Cell Transplantation; Humans; Immunosuppr | 2021 |
New Indication for Ibrutinib.
Topics: Adenine; Drug Approval; Graft vs Host Disease; Humans; Piperidines; Pyrazoles; Pyrimidines | 2017 |
Solving lymphoma's stem-cell problem.
Topics: Adenine; Agammaglobulinaemia Tyrosine Kinase; Allografts; Autografts; Azetidines; B-Lymphocytes; Cel | 2018 |
Changes in Immunosuppressive Treatment of Chronic Graft-versus-Host Disease: Comparison of 2 Surveys within Allogeneic Hematopoietic Stem Cell Transplant Centers in Germany, Austria, and Switzerland.
Topics: Adenine; Adult; Austria; Bronchiolitis Obliterans; Chronic Disease; Female; Germany; Graft vs Host D | 2019 |
Potassium content of irradiated packed red blood cells in different storage media: is there a need for additive solution-dependent recommendations for infant transfusion?
Topics: Adenine; Blood Preservation; Citrates; Cryoprotective Agents; Erythrocyte Transfusion; Erythrocytes; | 2013 |
The effect of timing of gamma-irradiation on hemolysis and potassium release in leukoreduced red cell concentrates stored in SAGM.
Topics: Adenine; Blood Safety; Blood Transfusion; Erythrocytes; Gamma Rays; Glucose; Graft vs Host Disease; | 2014 |
Ibrutinib treatment ameliorates murine chronic graft-versus-host disease.
Topics: Adenine; Animals; Disease-Free Survival; Drug Evaluation, Preclinical; Graft vs Host Disease; Hemato | 2014 |
Outcomes of Patients With Chronic Lymphocytic Leukemia and Richter's Transformation After Transplantation Failure.
Topics: Adenine; Adult; Aged; Antineoplastic Agents; Chronic Disease; Disease Progression; Factor Analysis, | 2015 |
Inhibition of BTK and ITK with Ibrutinib Is Effective in the Prevention of Chronic Graft-versus-Host Disease in Mice.
Topics: Adenine; Agammaglobulinaemia Tyrosine Kinase; Animals; B-Lymphocytes; Graft vs Host Disease; Hematop | 2015 |
58th American Society of Hematology Annual Meeting.
Topics: ADAMTS13 Protein; Adenine; Antibodies, Monoclonal; Antineoplastic Agents; Central Venous Catheters; | 2017 |
Rapamycin generates anti-apoptotic human Th1/Tc1 cells via autophagy for induction of xenogeneic GVHD.
Topics: Adenine; Animals; Apoptosis; Apoptosis Regulatory Proteins; Autophagy; Beclin-1; Cell Differentiatio | 2010 |
Tenofovir for treatment of hepatitis B virus reactivation in patients with chronic GVHD.
Topics: Adenine; Adult; Chronic Disease; Female; Graft vs Host Disease; Hepatitis B virus; Hepatitis B, Chro | 2011 |
Saliva and blood interferon gamma levels and IFNG genotypes in acute graft-versus-host disease.
Topics: Acute Disease; Adenine; Adolescent; Adult; Aged; Biomarkers; Child; Child, Preschool; Female; Follow | 2012 |
Comparison of X-ray vs. gamma irradiation of CPDA-1 red cells.
Topics: Adenine; Cell Membrane Permeability; Citrates; Dose-Response Relationship, Radiation; Erythrocyte Me | 2005 |
Quality control of blood irradiation: determination T cells radiosensitivity to cobalt-60 gamma rays.
Topics: Adenine; Blood Preservation; Cobalt Radioisotopes; Cold Temperature; Dose-Response Relationship, Rad | 2006 |
Model of acute graft-vs-host-disease in adult (SHR x BN.lx)F1 rats and its inhibition by adenine analog.
Topics: Adenine; Animals; Bone Marrow Transplantation; Disease Models, Animal; Female; Graft vs Host Disease | 1993 |
Prevention of acute graft-versus-host disease in rats using 9-(2-phosphonomethoxyethyl) adenine (PMEA).
Topics: Acute Disease; Adenine; Animals; Disease Models, Animal; Female; Graft vs Host Disease; Immunosuppre | 1993 |
Inhibition of acute graft-versus-host disease in (LEW.1W x LEW.1A)F1 rats using 9-(2-phosphonomethoxyethyl)-2,6-diaminopurine.
Topics: Adenine; Animals; Graft vs Host Disease; Histocompatibility Antigens; Immunosuppressive Agents; Inbr | 1997 |
GVHD after transfusion of stored RBC concentrates in a solution of mannitol, adenine, phosphate, citrate, glucose, and NaCl following trauma.
Topics: Accidents, Traffic; Adenine; Aged; Blood Preservation; Erythrocyte Transfusion; Graft vs Host Diseas | 2000 |
Decreased deformability of the X-ray-irradiated red blood cells stored in mannitol-adenine-phosphate medium.
Topics: Adenine; Blood Preservation; Blood Proteins; Chlorides; Erythrocyte Aggregation; Erythrocyte Deforma | 2000 |