vorinostat and Cutaneous T-Cell Lymphoma

vorinostat has been researched along with Cutaneous T-Cell Lymphoma in 54 studies

Vorinostat: A hydroxamic acid and anilide derivative that acts as a HISTONE DEACETYLASE inhibitor. It is used in the treatment of CUTANEOUS T-CELL LYMPHOMA and SEZARY SYNDROME.
vorinostat : A dicarboxylic acid diamide comprising suberic (octanedioic) acid coupled to aniline and hydroxylamine. A histone deacetylase inhibitor, it is marketed under the name Zolinza for the treatment of cutaneous T cell lymphoma (CTCL).

Research

Studies (54)

Authors

Clinical Trials (7)

Trial Overview

Trial Outcomes

Pruritis Evaluation

"The Itchy QoL is a validated pruritus specific quality of life instrument. It includes 22 pruritus-specific questions covering three major domains: symptoms, functioning, and emotions. The scale ranges from Never (1) to All The Time (5). The subscale scores consist of the average of the responses to the items in a given subscale. The overall score is the average of the responses to all items. Higher Itchy QoL scores indicate worse quality of life.~LS mean (and 95% CI) of the overall change from baseline across time points through 6-month assessment (including End of Cycles 1, 3, and 5 time points only) are calculated from MMRM with treatment, disease type, disease stage, and region as fixed effects and baseline score as a covariate." (NCT01728805)
Timeframe: Cycle 1, 3, and 5

Overall Response Rate

The ORR was defined as the count of subjects who had a confirmed CR or PR, defined as documented CR or PR per Global Composite Response Score that was confirmed by a subsequent observation at least 4 weeks later. Overall Response Rate was determined based on the response in all compartments (lymph nodes, skin, peripheral blood, and viscera), referencing Olsen, 2011 as follows: Complete Response (CR) = complete disappearance of all clinical evidence of disease; Partial Response (PR) = regression of measurable disease; Stable Disease (SD) = failure to attain CR, PR, or PD; Progressive Disease (PD) = PD in any compartment; Relapse = recurrence of disease in prior CR in any compartment. (NCT01728805)
Timeframe: at the end of cycle 1 (26-28 days), and then every other cycle in Year 1 (cycle 3, 5, 7, 9, 11, 13), and every 16 weeks (cycle 17, 21, etc.) in Year 2 and beyond until progression up to 36 months

Progression Free Survival

"Progression was defined as follows, based on Olsen (2011):~Lymph nodes: ≥ 50% increase in SPD from baseline of lymph nodes, any new node > 1.5 cm in the long axis or > 1 cm in the short axis if 1-1.5 cm in the long axis that is proven to be N3 histologically, or > 50% increase from nadir in SPD of lymph nodes in those with PR~Skin: ≥ 25% increase in skin disease from baseline, new tumors (T3) in patients with T1, T2 or T4 only skin disease, or in those with CR or PR, increase of skin score of greater than the sum of nadir plus 50% baseline score~Blood: B0 to B2, > 50% increase from baseline and at least 5,000 neoplastic cells/μL36, or > 50% increase from nadir and at least 5,000 neoplastic cells/μL~Viscera: > 50% increase in size (SPD) of any organs involved at baseline, new organ involvement, or > 50% increase from nadir in the size (SPD) of any previous organ involvement in those with PR" (NCT01728805)
Timeframe: From date of randomization at every visit until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months

Quality of Life (QoL) Assessment - Skindex-29 Symptoms Scale Score

"Skindex-29 rates 29 items assessing 3 domains (emotions, symptoms, & functioning) on a linear scale from 0 (never) to all the time (100). Higher scores = higher impact of skin disease.~FACT-G rates 27 items in 4 domains (physical well-being, social/family well-being, emotional well-being, functional well-being) on a 5-point scale from 0 (not at all) to 4 (very much). Higher scores = better QoL.~EuroQoL lvl 3 (Eq-5D-3L) rates mobility, self-care, usual activities, pain/discomfort and anxiety/depression on 3 levels - no problems, some problems, extreme problems. Score is calculated using a set of item weights to derive a single score ranging from -0.109 to 1, with 1 representing full health.~LS mean (and 95% CI) of the overall change from baseline across time points through 6-month assessment (including End of Cycles 1, 3, and 5 time points only) are calculated from MMRM with treatment, disease type, disease stage, and region as fixed effects and baseline score as a covariate." (NCT01728805)
Timeframe: Cycle 1, 3, and 5

Percent of Participants With a Serious Drug-related Adverse Event (AE)

"A serious adverse event (SAE) was any AE occurring at any dose that resulted in death, was life-threatening, resulted in a persistent or significant disability/incapacity, resulted in or prolonged an existing inpatient hospitalization, was a congenital anomaly/birth defect, was a cancer, or was an overdose.~A drug-related SAE was one that was thought to be possibly, probably, or definitely related to the study drug." (NCT00907738)
Timeframe: From the first dose of study drug until the patient experiences disease progression, withdraws consent, or develops unacceptable toxicity (from Day 1 up to 4 years and 9 months)

Maximum Tolerated Dose (MTD) as Determined by the Number of Participants With Dose Limiting Toxicities

Number of patients with Dose Limiting Toxicities (DLT). A DLT is an adverse event that determined the treatment dose level was not tolerable for that patient in Cycle 1. (NCT00127101)
Timeframe: Day 1 to day 28

Number of Participants Who Responded to Treatment

"Disease burden as assessed by the pre-specified Severity Weighted Assessment Tool (SWAT) measurement. A Response is defined as equal to or greater than 50% improvement in SWAT score.~SWAT Score is determined by the Lesions classified as patch, plaque, or tumor. The sum of percent of total body surface area (%TBSA) by lesion type is derived and multiplied by a factor of 1 (for patch), 2 (for plaque), or 4 (for tumor). The skin score total is derived by summing the skin score subtotals for patches, plaques and tumors. The skin score total is dimensionless and can range from 0 to 400" (NCT00127101)
Timeframe: Every 28 days for up to 6 Months of Treatment

Part I: Number of Participants Experiencing Dose Limiting Toxicity (DLT)

"A DLT was defined as any of the following (per Common Terminology Criteria for Adverse Events [CTCAE] version 3.0):~Grade 3 (severe)-4 (life-threatening) neutropenia with fever ≥ 38.5ºC~Grade 3-4 neutropenia with an infection requiring antibiotic or antifungal treatment~Grade 4 neutropenia lasting at least 5 days~Grade 4 thrombocytopenia~Other Grade 4 hematologic toxicity, including a decrease in hemoglobin, only at the discretion of the principal investigator~Grade 3 or 4 non-hematologic event, except which are manageable by supportive care or non-prohibited therapies" (NCT00771472)
Timeframe: Day 1 to Day 28

Part I: Maximum Drug Concentration (Cmax)

"Blood samples taken as follows:~Day 1 & Day 28 of Cycle 1: pre dose, and 0.25, 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 10, 12 and 24 hours after dosing of vorinostat." (NCT00771472)
Timeframe: Days 1 & 28 of Cycle 1

Part I: The Amount of Time it Takes for the Drug Concentration to Decrease by Half (T1/2)

"Blood samples taken as follows:~Day 1 & Day 28 of Cycle 1: pre dose, and 0.25, 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 10, 12 and 24 hours after dosing of vorinostat." (NCT00771472)
Timeframe: Days 1 & 28 of Cycle 1

Part I: Time at Which Cmax Occurs (Tmax)

"Blood samples taken as follows:~Day 1 & Day 28 of Cycle 1: pre dose, and 0.25, 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 10, 12 and 24 hours after dosing of vorinostat." (NCT00771472)
Timeframe: Days 1 & 28 of Cycle 1

Part I: Total Drug Exposure (Area Under the Concentration Curve, AUC[0-24 Hours])

"Blood samples taken as follows:~Day 1 & Day 28 of Cycle 1: pre dose, and 0.25, 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 10, 12 and 24 hours after dosing of vorinostat." (NCT00771472)
Timeframe: Days 1 & 28 of Cycle 1

Parts I & II: Number of Participants Experiencing Clinical or Laboratory Adverse Experiences (AE)

A laboratory AE is defined as any unfavorable & unintended change in the chemistry of the body temporally associated with the use of study product, whether or not considered related to the use of the product. A clinical AE is defined similarly but also includes changes in structure or function of the body. (NCT00771472)
Timeframe: Day 1 up until 30 days post study completion or early termination (up to approximately 506 days)

Reviews

17 reviews available for vorinostat and Cutaneous T-Cell Lymphoma

Trials

9 trials available for vorinostat and Cutaneous T-Cell Lymphoma

Other Studies

28 other studies available for vorinostat and Cutaneous T-Cell Lymphoma