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

NCT02223208 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 89

Last updated 2025-12-02

No results posted yet for this study

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.

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

Interventions

DRUG

Ro-CHOEP-21 (PHASE I)

Romidepsin (dose escalation) Starting dose: 12mg/ms iv day +1 and +8 Dose modification according to toxicity: * 14mg/ms day +1 and +8 * 10mg/ms day +1 and +8 * 8mg/ms day +1 and +8 CHOEP-21 * Doxorubicin 50 mg/ms iv day +1 or +2, * Vincristin 1.4 mg/ms (maximum 2.0 mg total dose) iv day+1 or +2 * Cyclophosphamide 750 mg/ms iv day +1 or +2 * Etoposide 100mg/ms iv from day +1 to +3 or from day +2 to +4 * Prednisone100 mg orally from days +1 to +5 or from days +2 to +6 PR or CR:Ro-CHOEP-21 for 3 additional cycles followed by stem cell mobilization and transplantation phase (CR --\> AUTO-SCT, PR --\> ALLO-SCT)

DRUG

Ro-CHOEP-21 (PHASE II)

Ro-CHOEP-21 x 3 cycles * Romidepsin dose according to phase I iv day +1 and +8 * Doxorubicin 50 mg/ms iv day +1 or +2, * Vincristin 1.4 mg/ms (maximum 2.0 mg total dose) iv day+1 or +2, * Cyclophosphamide 750 mg/ms iv day +1 or +2 * Etoposide 100mg/ms iv from day +1 to +3 or from day +2 to +4 * Prednisone100 mg orally from days +1 to +5 or from days +2 to +6 PR or CR: Ro-CHOEP-21 for 3 additional cycles followed by stem cell mobilization and transplantation phase (CR --\> AUTO-SCT, PR --\> ALLO-SCT)

Sponsors & Collaborators

  • Fondazione Italiana Linfomi - ETS

    lead OTHER

Principal Investigators

  • Paolo Corradini, Prof · Fondazione IRCCS Istituto Nazionale dei Tumori di Milano

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-09-30
Primary Completion
2020-10-31
Completion
2026-02-28

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02223208 on ClinicalTrials.gov