Conditions: Peripheral T-cell Lymphoma
Keywords: peripheral T-cell lymphoma T-cell lymphoma romidepsin
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 131
Healthy volunteers: no

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 description:
This is a Phase II, non-randomized, open-label, single-arm trial. This study is designed on the basis of complete response (CR) or unconfirmed CR \[CR(u)\] 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.

Arms:
arm 1: Participants received romidepsin 14 mg/m\^2 administered intravenously over 4 hours on Days 1, 8, and 15 of a 28-day cycle. Participants continued on monthly cycles of romidepsin. The planned duration of study therapy was 6 cycles. Patients who responded could continue beyond 6 cycles until disease progression or other withdrawal criteria were met. For participants treated for 12 or more cycles, maintenance dosing (2 doses per cycle) was permitted.

Interventions: intervention 1: Romidepsin
Intervention descriptions: intervention 1: Romidepsin intravenously (through a vein) over 4 hours on Days 1, 8 and 15 of each 28-day cycle.

Protocol document: