Efficacy of a Treatment With CHOP and Lenalidomide in First Line in Angioimmunoblastic T-cell Lymphoma (AITL)

July 23, 2021 updated by: The Lymphoma Academic Research Organisation

STUDY OF THE EFFICACY AND SAFETY OF FIRST LINE TREATMENT WITH CHOP AND LENALIDOMIDE (Rev-CHOP) IN PATIENTS AGED FROM 60 TO 80 YEARS WITH PREVIOUSLY UNTREATED ANGIOIMMUNOBLASTIC T-CELL LYMPHOMA (AITL)

This study aims to evaluate the efficacy of lenalidomide associated with CHOP as measured by complete response rate at the end of treatment. Approximately 80 patients aged between 60 and 80 years will be included, to have 70 evaluable patients. The treatment consists of two phases of four 3-weeks cycles: induction phase and consolidation phase, for a total treatment duration of 24 weeks. Each cycle will be broken down as follows: chemotherapy will be administered in the hospital on day 1, prednisone is continued for 5 days and lenalidomide is taken for 14 days. Patients will be followed for at least 18 months after inclusion of the last patient.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Phase 2

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

  • Belgium
      • Bruxelles, Belgium, 1200
        • Université Catholique de Louvain Saint Luc
      • Gent, Belgium, 9000
        • Universitair Ziekenhuis Gent
      • Yvoir, Belgium, 5530
        • Université Catholique de Louvain Mont Godinne
  • France
      • Amiens, France, 80054
        • Chu D'Amiens - Hopital Sud
      • Angers, France, 49033
        • CHU Angers
      • Avignon, France, 84902
        • CH d'Avignon - Hopital Henri Duffaut
      • Besançon, France, 25030
        • CHU Jean Minjoz
      • Bordeaux, France, 33076
        • Institut Bergonié
      • Bordeaux, France, 33077
        • Polyclinique Bordeaux Nord Aquitaine
      • Châlon sur saône, France, 71100
        • Centre Hospitalier Chalon Sur Saône William Morey
      • Clermont Ferrand, France, 63000
        • CHU Estaing
      • Corbeil Essonnes, France, 91106
        • CH Sud Francilien de Corbeil
      • Créteil, France, 94010
        • Hopital Henri Mondor
      • Dijon, France, 21000
        • CHU de Dijon
      • Grenoble, France, 38043
        • CHU de Grenoble
      • La roche sur Yon, France, 85925
        • CH Départemental
      • Lille, France, 59037
        • CHRU de Lille
      • Marseille, France, 13273
        • Institut Paoli Calmette
      • Meaux, France, 77104
        • Centre Hospitalier de Meaux
      • Montpellier, France, 34295
        • CHU Saint-Eloi
      • Nantes, France, 44093
        • Chu Hotel Dieu
      • Paris, France, 75475
        • Hôpital Saint Louis
      • Paris, France, 75743
        • Hôpital Necker
      • Pessac, France, 33604
        • Centre Francois Magendie
      • Pierre Bénite, France
        • CHU Lyon Sud
      • Pringy, France, 74370
        • Centre Hospitalier de la Région d'Annecy
      • Reims, France, 51092
        • CHU Robert Debré
      • Rennes, France, 35003
        • CHU Pontchaillou
      • Rouen, France, 76038
        • Centre Henri Becquerel
      • Vandoeuvre les Nancy, France, 54511
        • CHU Brabois

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

60 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with histologically proven T-cell angioimmunoblastic lymphoma (AITL)
  • Age from 60 to 80 years.
  • Eastern Cooperative Oncology Group performance status 0 to 2.
  • No previous therapy (except corticosteroids providing they have been initiated less than 15 days before inclusion).
  • Spontaneous life expectancy > 1 month.
  • Written informed consent. The Lenalidomide Information Sheet (in appendix N of the protocol) will be given to each patient receiving lenalidomide study therapy. The patient must read this document prior to starting lenalidomide study treatment and each time they receive a new supply of study drug.

  • Male patients must:

    • Agree to use a condom during sexual contact with a FCBP, even if they have had a vasectomy, throughout study drug therapy, during any dose interruption and after cessation of study therapy.
    • Agree to not give semen or sperm during study drug therapy and for a period after end of study drug therapy.

  • All patients must:

    • Have an understanding that the study drug could have a potential teratogenicity.
    • Agree to abstain from donating blood while taking study drug therapy and following discontinuation of study drug therapy.
    • Agree not to share study medication with another person.
    • Be counselled about pregnancy precautions and risks of foetal exposure.

Exclusion Criteria:

  • Others categories of T-cell lymphoma.
  • Central nervous system involvement by lymphoma.
  • Any previous therapy for lymphoma except short-term corticosteroids (maximum 10 days) before inclusion.
  • Contra-indication to any drug included in the CHOP regimen.
  • Serious medical or psychiatric illness likely to interfere with participation in this clinical study (according to the investigator's decision).
  • Active bacterial, viral or fungal infection, in particular active hepatitis B or C and HIV positive serological test.
  • Impaired renal function (Creatinine clearance <50 ml/min (as calculated by the Cockcroft-Gault formula)) or impaired liver function tests (total bilirubin level > 30 µmol/L, transaminases > 2.5 upper normal limits) unless they are related to the lymphoma.
  • Poor bone marrow reserve as defined by neutrophils < 1.0 x 109/L or platelets < 100 x 109/L, unless related to bone marrow infiltration.
  • Any history of malignancy, other than that treated in this research, unless the patient has remained free of the disease for over 5 years.
  • Treatment with any investigational drug within 30 days before planned first cycle of chemotherapy and during the study.
  • Hypersensitivity to the active substance or to any of the excipients.
  • Pregnant and lactating woman

  • Females of Childbearing potential (FCBP*) according to the Pregnancy Prevention Plan in appendix L of the protocol)

    • The Pregnancy Prevention Plan defines a female of childbearing potential as a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy or 2) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months).

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: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: lenalidomide
lenalidomide + CHOP
Drug: Lenalidomide
Lenalidomide

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Complete response rate
Time Frame: maximum 60 days after last study drug intake
maximum 60 days after last study drug intake

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: Corinne HAIOUN, Lymphoma Study Association

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 (ACTUAL)

November 1, 2011

Primary Completion (ACTUAL)

March 1, 2018

Study Completion (ACTUAL)

March 21, 2019

Study Registration Dates

First Submitted

January 20, 2012

First Submitted That Met QC Criteria

March 12, 2012

First Posted (ESTIMATE)

March 14, 2012

Study Record Updates

Last Update Posted (ACTUAL)

July 26, 2021

Last Update Submitted That Met QC Criteria

July 23, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REVAIL

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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