A Single Agent Phase II Study of Romidepsin (Depsipeptide, FK228) in the Treatment of Cutaneous T-cell Lymphoma (CTCL)
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|ClinicalTrials.gov Identifier: NCT00106431|
Recruitment Status : Completed
First Posted : March 25, 2005
Results First Posted : April 23, 2010
Last Update Posted : March 16, 2011
|Condition or disease||Intervention/treatment||Phase|
|Cutaneous T-cell Lymphoma||Drug: romidepsin (depsipeptide, FK228)||Phase 2|
Responses were evaluated according to a composite assessment (Objective Primary Disease Response Evaluation Criteria [OPDREC]) that included cutaneous manifestations of disease, lymph node involvement, and circulating malignant T-cells (Sézary cells). Skin involvement was measured using a weighted body surface area skin assessment tool (WBSA/SWAT) or an erythroderma score, depending upon the pt's disease. Disease response was assessed by the Investigators and an Independent Response Review Committee (IRRC) with the IRRC assessment considered supportive of the Investigator's evaluations using the following criteria:
Complete Response (CR):
- Complete resolution of skin patches, skin plaques, and skin tumors, or erythroderma
- No evidence of abnormal lymph nodes
- Absence of circulating Sézary cells.
- No evidence of new tumors (cutaneous or non-cutaneous)
- Findings confirmed by skin biopsy
Clinical complete response (CCR):
- Same as CR but without skin biopsy
Partial Response (PR):
- ≥50% improvement in the summation of (change in Skin + change in Lymph Node + change in Peripheral Blood) with
- At least >30% improvement in Skin and
- No worsening in Lymph Node or Sézary cells.
- No evidence of new tumors (cutaneous/non-cutaneous)
Stable Disease (SD):
- Not enough improvement or worsening in the summation of (change in Skin + change in Lymph Node + change in Peripheral Blood to qualify as PR or PD
- No evidence of new tumors (cutaneous/non-cutaneous)
- SD90 was defined as documented evidence of SD for at least 90 Days Duration
Progressive Disease (PD):
- Evidence of new tumor (cutaneous or non-cutaneous), OR
- >25% worsening in the summation of (change in Skin + change in Lymph Node + change in Peripheral Blood) with >15% worsening in change in Skin.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||102 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Single Agent Phase II Study of Depsipeptide (FK228) in the Treatment of Cutaneous T-cell Lymphoma|
|Study Start Date :||January 2005|
|Actual Primary Completion Date :||June 2008|
|Actual Study Completion Date :||December 2008|
- Drug: romidepsin (depsipeptide, FK228)
Study patients received romidepsin at a dose of 14 mg/m^2 intravenously over 4 hours on Days 1, 8 and 15 of each 28-day cycle. The duration of study treatment was 6 cycles although patients who showed an objective response or stable disease could continue to receive therapy, at the discretion of the investigator, until disease progression or another withdrawal criterion was met.
- The Percent of Patients (Pts) With Objective Disease Response [ Time Frame: 6 months ]The percent of pts with confirmed Objective Disease Response (confirmed best responses of complete response [CR], clinical complete response [CCR], or partial response [PR]). Responses were evaluated according to a composite assessment (Objective Primary Disease Response Evaluation Criteria - OPDREC).
- Duration of Objective Disease Response [ Time Frame: Up to 10 months; median duration of follow up was 5.1 months ]Duration of Objective Response was defined as the number of months from the date of the first disease response (clinical complete response [CCR], or partial response [PR]) (later confirmed) until the date of progression and was determined using Kaplan-Meier product-limit estimates. In this analysis, pts who did not progress were censored as of their last evaluation with an OPDREC assessment.
- Time to Objective Disease Response [ Time Frame: Up to 10 months ]Time to Objective Response was defined as the time in months from first dose date to the first date of objective disease response (later confirmed) and time to CCR was defined as the time in months from first dose date to the first date of CCR (later confirmed).
- Time to Disease Progression [ Time Frame: Up to 10 months; median duration of follow up was 6.1 months ]Time To Progression was defined as the duration from the date of the first study drug dose to the date of progression (PD). In this analysis, pts who did not progress were censored at their last evaluation with an OPDREC assessment.
- Decrease in Pruritus Visual Analogue Scale (VAS) Score of ≥30 mm or a Score of 0 for at Least 2 Consecutive Cycles. [ Time Frame: Up to 10 months ]Pruritus was reported monthly by pts using a 0 (no itching) to 100 (unbearable itching) mm visual analog scale (VAS). Pts were considered to have significant pruritus if the baseline VAS score was ≥ 30 mm. Clinically meaningful reduction in pruritus was defined as a decrease in VAS score of ≥ 30 mm or a score of 0 for at least 2 consecutive cycles.
- Duration of Objective Disease Control (ODC) [ Time Frame: Up to 10 months; median duration of follow up was 6.0 months ]For pts with confirmed ODC (pts with CR, CCR, PR, SD90 [stable disease for 90 days]) based on OPDREC, duration of ODC was summarized with descriptive statistics, including number of censored observations, and 25th, 50th, 75th percentiles of distribution, based on Kaplan-Meier product limit estimates. For pts with confirmed progressive disease (PD), duration of ODC was calculated from first date of study drug to first date of diagnosis of confirmed PD. For pts without confirmed PD, duration of ODC was calculated from first date of study drug to date of the last visit with any OPDREC data.
- Percent of Pts With Objective Disease Control [ Time Frame: Up to 10 months ]The percent of pts with confirmed ODC (CR, CCR, PR and SD90) based on OPDREC was summarized.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00106431
|United States, California|
|UCLA Jonsson Cancer Center|
|Los Angeles, California, United States, 90095|
|Stanford Comprehensive Cancer Center|
|Stanford, California, United States, 94305|
|United States, Massachusetts|
|Boston Medical Center|
|Boston, Massachusetts, United States, 02118|
|United States, Pennsylvania|
|University of Pennsylvania Abrahamson Cancer Center|
|Philadelphia, Pennsylvania, United States, 19104|
|United States, Tennessee|
|Vanderbilt-Ingram Cancer Center|
|Nashville, Tennessee, United States, 37232|
|United States, Texas|
|MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Various Cities, France|
|Various Cities, Germany|
|Various Cities, Poland|
|Various Cities, Russian Federation|
|Various Cities, United Kingdom|
|Study Director:||Jean Nichols, Ph.D.||Gloucester Pharmaceuticals, Inc.|