A Study of Escalating Doses of Romidepsin in Association With CHOP in the Treatment of Peripheral T-Cell Lymphomas (Ro-CHOP)

May 21, 2014 updated by: The Lymphoma Academic Research Organisation

A Phase IB/II Study of Escalating Doses of Romidepsin (Istodax®) in Association With CHOP (Ro-CHOP) in the Treatment of Peripheral T-Cell Lymphomas

This study is an open label, multicenter study with two phases:

  • A dose escalation phase of Romidepsin administered IV at day 1 and 8 or at day 1 without day 8 in combination with cyclophosphamide, doxorubicin, vincristine and prednisone (CHOP)administered every 3 weeks for 8 cycles in patients with T-cell lymphoma.
  • An expansion phase in order to assess the safety and the efficacy of the association of the recommended dose of Romidepsin associated with CHOP in a population of patients with T-cell lymphoma.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The primary objective of the study is to determine the feasibility of the combination and the recommended dose (RD) of Romidepsin when administered in association with CHOP in a population of patients with newly diagnosed Peripheral T-cell lymphoma (PTCL) as measured by the toxicities during treatment.

Secondary objectives:

  • To assess the safety of the association Romidepsin and CHOP,
  • To assess the efficacy of the association of Romidepsin and CHOP: response rate and complete response rate, progression-free survival, response duration and overall survival.

Study Type

Interventional

Enrollment (Actual)

37

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Créteil, France, 94010
        • Hopital Henri Mondor
      • Dijon, France, 21000
        • CHU de Dijon
      • Lille, France, 59037
        • Hôpital Claude Huriez
      • Lyon cedex 8, France, 69373
        • Centre Léon Bérard
      • Paris, France, 75475
        • Hopital St Louis
      • Pierre-Bénite, France, 69495
        • Centre Hospitalier Lyon Sud
      • Rouen, France, 76038
        • Centre Henri Becquerel
      • Villejuif, France, 94805
        • Institut Gustave Roussy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

  1. Inclusion Criteria:

    1. Patients with histologically confirmed Peripheral T-cell Lymphoma (PTCL), not previously treated ; all subtypes may be included except HTLV-1-related T-cell lymphoma, cutaneous T-cell lymphoma (mycosis fungoid and Sézary syndrome), and ALK+ PTCL,
    2. Ann Arbor stages II - IV
    3. Aged from 18 to 80 years,
    4. ECOG performance status 0, 1 or 2,
    5. Signed informed consent,
    6. Negative pregnancy test for females of childbearing potential (FCBP),
    7. FCBP using an effective method of birth control (i.e. hormonal contraceptive, intrauterine device, diaphragm with spermicide, condom with spermicide or abstinence) for the treatment period and for 1 month thereafter; Males using an effective method of birth control for the treatment period and 3 months thereafter,
    8. Life expectancy of ≥ 90 days (3 months)

  2. Exclusion Criteria:

    1. Other types of lymphomas, e.g. B-cell lymphoma
    2. Ann Arbor stage I
    3. Previous treatment for PTCL with immunotherapy or chemotherapy except for short-term corticosteroids before inclusion
    4. Previous radiotherapy for PTCL except if localized to one lymph node area
    5. Central nervous system - meningeal involvement
    6. Contraindication to any drug contained in the chemotherapy regimen
    7. HIV infection, active hepatitis B or C
    8. Any serious active disease or co-morbid medical condition (according to investigator's decision)

    9. Any of the following laboratory abnormalities

      • Absolute neutrophil count (ANC) < 1,500 cells/mm3 (1.5 x 109/L),
      • Platelet count < 100,000/mm3 (100 x 109/L), or 75,000 if bone marrow is involved,
      • Serum SGOT/AST or SGPT/ALT ≥ 5.0 x upper limit of normal (ULN),
      • Serum total bilirubin > 2.0 mg/dL (34 µmol/L), except in case of hemolytic anemia,
      • Low K+ (inferior to low normal level) and low Mg+ (inferior to low normal level)levels, except if corrected before beginning the chemotherapy,
    10. Use of oral contraceptive and contraceptive patches,
    11. Calculated creatinine clearance (Cockcroft-Gault formula) of < 50 mL /min,
    12. Prior history of malignancies other than lymphoma (except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast) unless the subject has been free of the disease for ≥ 3 years,
    13. Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form,
    14. Left Ventricular Ejection Fraction < 45% (calculated by echocardiographic or scintigraphic methods),
    15. Patients with congenital long QT syndrome, history of significant cardiovascular disease and/or taking drugs leading to significant QT prolongation,
    16. Corrected QT interval > 480 msec (using the fridericia formula)
    17. Use of any standard or experimental anti-cancer drug therapy within 28 days of the initiation (Day 1) of study drug ,
    18. Pregnant or lactating females or women of childbearing potential not will-ing to use an adequate method of birth control for the duration of the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Romidepsin dose 10mg/m²
Drug: Romidepsin and CHOP
Romidepsin dose administered IV at day 1 and 8 or at day 1 without day 8 in combination with cyclophosphamide, doxorubicin, vincristine and prednisone (CHOP) administered every 3 weeks for 8 cycles in patients with T-cell lymphoma
Experimental: Romidepsin dose 12mg/m²
Drug: Romidepsin and CHOP
Romidepsin dose administered IV at day 1 and 8 or at day 1 without day 8 in combination with cyclophosphamide, doxorubicin, vincristine and prednisone (CHOP) administered every 3 weeks for 8 cycles in patients with T-cell lymphoma
Experimental: Romidepsin dose 14mg/m²
Drug: Romidepsin and CHOP
Romidepsin dose administered IV at day 1 and 8 or at day 1 without day 8 in combination with cyclophosphamide, doxorubicin, vincristine and prednisone (CHOP) administered every 3 weeks for 8 cycles in patients with T-cell lymphoma
Experimental: Romidepsin dose 8mg/m²
Drug: Romidepsin and CHOP
Romidepsin dose administered IV at day 1 and 8 or at day 1 without day 8 in combination with cyclophosphamide, doxorubicin, vincristine and prednisone (CHOP) administered every 3 weeks for 8 cycles in patients with T-cell lymphoma

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of Dose Limiting Toxicities
Time Frame: 42 days
42 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete Response Rate(CR) at the end of treatment
Time Frame: 30 days after the end of treatment
30 days after the end of treatment
Progression-free survival (PFS)
Time Frame: from the date of inclusion to the date of first documentated disease progression, relapse or death from any cause
from the date of inclusion to the date of first documentated disease progression, relapse or death from any cause
Duration of Response
Time Frame: from the date of first documentation of a response to the date of first documented evidence of progression/relapse or death from any cause
from the date of first documentation of a response to the date of first documented evidence of progression/relapse or death from any cause
Safety of association Romidepsin-CHOP
Time Frame: from the date of informed consent signature to 90 days after the last drug administration
Toxicities occured during the trial for all patient from the date of informed consent signature to 90 days after the last drug administration will be measured and reported for all grades toxicities according to CTCAE v4.
from the date of informed consent signature to 90 days after the last drug administration
Overall Response at the end of treatment
Time Frame: 30 days after the end of treatment
30 days after the end of treatment
Overall Survival (OS)
Time Frame: from the date of inclusion to the date of first documentated disease progression, relapse or death from any cause
from the date of inclusion to the date of first documentated disease progression, relapse or death from any cause

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Lymphoma Academic Research Organisation

Investigators

  • Principal Investigator: Bertrand COIFFIER, Professor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Actual)

November 1, 2012

Study Completion (Actual)

March 1, 2014

Study Registration Dates

First Submitted

January 14, 2011

First Submitted That Met QC Criteria

January 19, 2011

First Posted (Estimate)

January 20, 2011

Study Record Updates

Last Update Posted (Estimate)

May 22, 2014

Last Update Submitted That Met QC Criteria

May 21, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Ro-CHOP

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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