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Efficacy and Safety of Romidepsin CHOP vs CHOP in Patients With Untreated Peripheral T-Cell Lymphoma

NCT01796002 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 421

Last updated 2023-01-10

No results posted yet for this study

Summary

Primary objective of the study is to compare the efficacy of romidepsin when administered with CHOP versus CHOP alone in subjects with previously untreated peripheral T-cell lymphoma (PTCL) in terms of progression-free survival (PFS) assessed according to Response criteria for malignant lymphoma 1999 by a Response Adjudication Committee (RAC).

Conditions

  • Peripheral T-cell Lymphoma

Interventions

DRUG

Romidepsin + CHOP

Ro-CHOP administered in 3 week cycles for 6 cycles or until progression Romidepsin is administered at a dose of 12 mg/m² IV on day 1 and day 8 every 3 weeks.

DRUG

CHOP

CHOP (cyclophosphamide, doxorubicin, vincristine and prednisone) administered in 3 week cycles for 6 cycles.

Sponsors & Collaborators

  • The Lymphoma Academic Research Organisation

    lead OTHER

Principal Investigators

  • Emmanuel BACHY, Professor · CH Lyon Sud, Pierre Bénite, France

  • Vincent CAMUS, MD · Centre Henri Becquerel, Rouen, France

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2019-12-13
Completion
2022-12-13

Countries

  • Belgium
  • France
  • Germany
  • Italy
  • Portugal
  • Singapore
  • South Korea
  • Spain

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 NCT01796002 on ClinicalTrials.gov