Overview

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

Status:
Active, not recruiting

Trial end date:
2026-10-01

Target enrollment:

Participant gender:

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.

Phase:

Phase 1/Phase 2

Details

Lead Sponsor:

Fondazione Italiana Linfomi ONLUS

Treatments:

Cyclophosphamide
Doxorubicin
Etoposide
Etoposide phosphate
Liposomal doxorubicin
Prednisone
Romidepsin
Vincristine