Clinical Trial: A Single Agent Phase II Study of Romidepsin (Depsipeptide, FK228) in the Treatment of Cutaneous T-cell Lymphoma (CTCL)

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Single Agent Phase II Study of Depsipeptide (FK228) in the Treatment of Cutaneous T-cell Lymphoma

Brief Summary: GPI-04-0001 was a Phase II, non-randomized, open label, single arm study that was conducted at approximately 30 sites, primarily in the United States, Europe and Russia. It assessed the efficacy, safety, and tolerability of romidepsin as a treatment for cutaneous T-cell lymphoma (CTCL). Study patients (pts) received romidepsin in 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 pts 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.

Detailed Summary:

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):


Sponsor: Celgene Corporation

Current Primary Outcome: 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).


Original Primary Outcome:

Current Secondary Outcome:

  • 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.


Original Secondary Outcome:

Information By: Celgene

Dates:
Date Received: March 24, 2005
Date Started: January 2005
Date Completion:
Last Updated: March 14, 2011
Last Verified: March 2011