Trial intelligence / Profile preview

Romidepsin in Progressive or Relapsed Peripheral T-cell Lymphoma

NCT01456039Phase 2

Key facts

Status: Completed
Start: Dec 2011
Primary completion: Jul 2015
Countries: 1
Sponsor: Celgene Corporation
Modality: Small Molecules

Drugs: romidepsin
Conditions: peripheral T-cell lymphoma (PTCL)cutaneous T-cell lymphoma (CTCL)

Overview

Phase 2, open-label, single-arm trial of romidepsin in peripheral T-cell lymphoma (PTCL) and cutaneous T-cell lymphoma (CTCL), sponsored by Celgene Corporation. Primary endpoints: Number of Participants With Dose-limiting Toxicity at Day 28 and Overall Response Rate up to 100 days. Started Dec 2011; status: completed.

Design

1 arm

Study design: Non-randomizedOpen-label

Romidepsin
Romidepsin IV on Days 1, 8, 15 of each 28-day cycle.

Who it enrols

Patients with histologically confirmed PTCL or CTCL (excluding MF/SS unless transformed/relapsed) who have progressed after at least one systemic therapy. Must have adequate organ function and no significant cardiac abnormalities.

Endpoints

Primary

Number of Participants With Dose-limiting ToxicityDay 28
Overall Response Rateup to 100 days

Secondary

Treatment-Emergent Adverse Eventsup to 184.3 weeks
Area Under the Plasma Concentration-time Curve From Time Zero to Last Measurable ConcentrationDay 15
Maximum Plasma ConcentrationDay 15
Percentage of Participants With Abnormal Q-wave and T Wave Intervalsup to 100 days
Time to Responseup to 100 days
Duration of Responseup to 100 days
Time to Progressionup to 100 days

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