A Study of Escalating Doses of Romidepsin in Association With CHOP in the Treatment of Peripheral T-Cell Lymphomas

Phase 1/2 Completed 37 enrolled The Lymphoma Academic Research Organisation

Non-randomizedSingle-groupOpen-labelTreatment

Summary

This study is an open label, multicenter study with two phases: * A dose escalation phase of Romidepsin administered IV at day 1 and 8 or at day 1 without day 8 in combination with cyclophosphamide, doxorubicin, vincristine and prednisone (CHOP)administered every 3 weeks for 8 cycles in patients with T-cell lymphoma. * An expansion phase in order to assess the safety and the efficacy of the association of the recommended dose of Romidepsin associated with CHOP in a population of patients with T-cell lymphoma.

Timeline

Start: 2011-01
Primary completion: 2012-11
Completion: 2014-03

Publications

Dupuis J, Morschhauser F, Ghesquieres H, Tilly H, Casasnovas O, Thieblemont C, Ribrag V, Bossard C, Le Bras F, Bachy E, Hivert B, Nicolas-Virelizier E, Jardin F, Bastie JN, Amorim S, Lazarovici J, Martin A, Coiffier B. Combination of romidepsin with cyclophosphamide, doxorubicin, vincristine, and prednisone in previously untreated patients with peripheral T-cell lymphoma: a non-randomised, phase 1b/2 study. Lancet Haematol. 2015 Apr;2(4):e160-5. doi: 10.1016/S2352-3026(15)00023-X. Epub 2015 Mar 17.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Romidepsin	Peptide	8 mg/m2	Intravenous
Subject	Romidepsin	Peptide	10 mg/m2	Intravenous
Subject	Romidepsin	Peptide	12 mg/m2	Intravenous
Subject	Romidepsin	Peptide	14 mg/m2	Intravenous
Background	Cyclophosphamide	Other / unclassified	750 mg/m2	Intravenous
Background	Doxorubicin	Other / unclassified	50 mg/m2	Intravenous
Background	Prednisone	Other / unclassified	40 mg/m2	Oral
Background	Vincristine	Small molecule	1.4 mg/m2	Intravenous

A Study of Escalating Doses of Romidepsin in Association With CHOP in the Treatment of Peripheral T-Cell Lymphomas

Summary

Timeline

Publications

Drugs

Indications