Clinical Trial

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

Study acronym: FIL_PTCL13
Active, Not Recruiting Phase 1/2
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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.
Protocol Amendment History 22 amendments
This ClinicalTrials.gov record has been amended 22 times since 2014-08-21; most recent amendment 2025-12-01.
Status change: Recruiting → Active, Not Recruiting 2020-10-29
Status change: Active, Not Recruiting → Recruiting 2014-10-13
Trial Details
NCT Number NCT02223208
Lead Sponsor Fondazione Italiana Linfomi - ETS
Conditions Peripheral T-cell Lymphomas (PTCL), PTCL-NOS, Angioimmunoblastic T-cell Lymphoma (AITL), ALK- Anaplastic Large Cell Lymphoma (ALCL), Nodal Peripheral T-Cell Lymphoma of T Follicular Helper Cell Origin
Enrollment 89 participants
Start Date 2014-09
Primary Completion 2020-10 (estimated)
Study Completion 2026-02 (estimated)
Updated on ClinicalTrials.gov 2025-12-02