Clinical Trial: A Trial of Romidepsin for Progressive or Relapsed Peripheral T-cell Lymphoma

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: A Phase II, Multicenter, Open-Label Trial Evaluating The Activity And Tolerability Of Romidepsin (Depsipeptide, FK228) In Progressive Or Relapsed Peripheral T-Cell Lymphoma

Brief Summary: The purpose of this study is to evaluate the activity of romidepsin in patients with progressive or relapsed peripheral T-cell lymphoma (PTCL) who have already been treated with systemic therapy.

Detailed Summary: This is a Phase II, non-randomized, open-label, single-arm trial. This study is designed on the basis of complete response [CR or CR(u)] as the measure of efficacy, based on the best overall response of each patient. The sample size of 65 patients evaluable for efficacy would yield lower 95% confidence limits on the rate of CR + CR(u) that would range from 2.2% to 7.7%, if the observed rate of CR + CR(u) ranges from 8% to 15%. The study was amended to include an Extension Phase, during which patients at non-US sites who are benefitting from treatment can continue to receive romidepsin. The Extension Study Phase is active in EU countries where currently no Marketing Authorisation exists for romidepsin. Patients may remain on study until progressive disease occurs or they withdraw their consent and only serious adverse events and study drug administration data will continue to be collected and reported for these patients.
Sponsor: Celgene

Current Primary Outcome: Percentage of Participants With a Complete Response According to the International Workshop Response Criteria (IWC) for Non-Hodgkin's Lymphomas (NHL) Assessed by an Independent Review Committee [ Time Frame: Response was assessed after every 2 cycles of treatment and at completion of therapy, up until 31 October 2010 (maximum duration on study was 1086 days). ]

Original Primary Outcome:

Current Secondary Outcome:

• Percentage of Participants With Objective Disease Response [ Time Frame: Response was assessed after every 2 cycles of treatment and at completion of therapy, up until 31 October 2010 (maximum duration on study was 1086 days). ]
  Objective disease response was defined as patients with a Complete Response, Unconfirmed Complete Response or a Partial Response according to the IWC 1999 assessed by an independent review committee: CR, Cru defined above, PR defined as ≥50% decrease in size of 6 largest dominant nodes and/or nodal masses & extranodal index lesions and no increase of non-index lesions, liver, or spleen; no new sites of disease evident; skin lesions decreased by ≥50%.
• Duration of Objective Disease Response [ Time Frame: Response was assessed after every 2 cycles of treatment and at completion of therapy, up until 31 October 2010 (maximum duration on study was 1086 days). ]
  Duration of response was defined as the number of days from the date of the first disease response (Complete, Unconfirmed Complete or Partial Response) until the date of progression and was determined using Kaplan-Meier product-limit estimates. Progression was defined as: a ≥50% increase from the nadir in the individual sum of the products of the diameters of any index lesion; the reappearance of pathology, enlargement of liver/spleen, or unequivocal progression of non-measurable disease or appearance of any new lesions.
• Duration of Complete Disease Response [ Time Frame: Response was assessed after every 2 cycles of treatment and at completion of therapy, up until 31 October 2010 (maximum duration on study was 1086 days). ]
  Duration of response was defined as the number of days from the date of the first disease response (Complete or Unconfirmed Complete) until the date of progression and was determined using Kaplan-Meier product-limit estimates. Progression was defined as: a ≥50% increase from the nadir in the individual sum of the products of the diameters of any index lesion; the reappearance of pathology, enlargement of liver/spleen, or unequivocal progression of non-measurable disease or appearance of any new lesions.
• Time to Disease Progression [ Time Frame: Response was assessed after every 2 cycles of treatment and at completion of therapy, up until 31 October 2010 (maximum duration on study was 1086 days). ]
  Time to progression (≥50% increase from the nadir in the individual sum of the products of the diameters of any index lesion; the reappearance of pathology, enlargement of liver/spleen, or unequivocal progression of non-measurable disease or appearance of any new lesions) was defined as the duration from the date of the first study drug dose to the date of relapse or progression as reported by the independent review committee and was determined using Kaplan-Meier product-limit estimates.
• Change in Eastern Cooperative Oncology Group (ECOG) Performance Status [ Time Frame: From Baseline to 31 March 2010 (up to 33.4 months). ]

  The ECOG scale is as follows:

  Grade 0: Fully active, able to perform all pre-disease activities without restriction; Grade 1: Restricted in physically strenuous activity, ambulatory, able to carry out light work; Grade 2: Ambulatory and capable of all self-care but unable to work. Up and about more than 50% of waking hours; Grade 3: Capable of only limited self-care, confined to bed or chair > 50% of waking hours; Grade 4: Completely disabled. Cannot carry on any self-care. Confined to bed or chair.

  Data reported is the shift from Baseline ECOG score to best on-study assessment score.

Original Secondary Outcome:

Information By: Celgene

Dates:
Date Received: January 23, 2007
Date Started: June 21, 2007
Date Completion: December 31, 2017
Last Updated: March 31, 2017
Last Verified: March 2017