drugset
drugset / Trial / NCT02223208

Ro Plus CHOEP as First Line Treatment Before HSCT in Young Patients With Nodal Peripheral T-cell Lymphomas

NCT02223208 ↗

Phase 1/2 Active not recruiting 89 enrolled Fondazione Italiana Linfomi - ETS
NaSingle-groupOpen-labelTreatment

Summary

This is a multicenter study that includes two phases: 1. A phase I study to define the maximum tolerated dose (MTD) of Romidepsin in addition to CHOEP-21 and to test the safety and feasibility of CHOEP-21 in combination with dose escalation of Romidepsin (8, 10, 12, 14 mg). The dose level defined as MTD of Romidepsin will be used for the subsequent phase II study. 2. A phase II study to evaluate the efficacy (response rate, progression free survival and overall survival) and safety of Ro-CHOEP-21 incorporated into a treatment strategy including SCT.

Timeline

Start
2014-09
Primary completion
2020-10
Completion
2026-02

Drugs

EvaluationDrugModalityDoseRoute
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 Etoposide Small molecule 100 mg/m2 Intravenous
Background Prednisone Other / unclassified 100 mg Oral
Background Vincristine Small molecule 1.4 mg/m2 Intravenous

Indications

ALK-negative anaplastic large cell lymphoma Nodal T-follicular helper cell lymphoma, follicular type angioimmunoblastic T-cell lymphoma peripheral T-cell lymphoma, not otherwise specified