Revlimid Dose 25 mg in Association With (R-CHOP) in the Treatment Follicular Lymphoma (R2-CHOP2)

December 4, 2023 updated by: The Lymphoma Academic Research Organisation

A Phase Ib/II Study of Escalating Doses of Revlimid in Association With R-CHOP (R2-CHOP) in the Treatment of B-cell Lymphoma

The purpose of the study is to assess the efficacy of the association of Lenalidomide (Revlimid) and R-CHOP (Rituximab, Cyclophosphamide, Doxorubicin, vincristine and Prednisone) in a population of patients with follicular lymphoma as measured by the response rate at the end of treatment.

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

  • France
      • Bordeaux, France, 33076
        • Institut Bergonie
      • Bordeaux, France, 33077
        • Polyclinique Bordeaux Nord Aquitaine
      • Clermont ferrand, France, 63000
        • CHU Estaing
      • Creteil, France, 94010
        • Hopital Henri MONDOR
      • Dijon, France, 21034
        • CHU de Dijon
      • Lille, France, 59037
        • Chru Lille
      • Lyon, France, 69373
        • Centre Léon Bérard
      • Marseille, France, 13273
        • Institut Paoli Calmettes
      • Metz, France, 57038
        • Hôpital Notre Dame de Bon Secours
      • Montpellier, France, 34295
        • Hopital Saint Eloi
      • Nantes, France, 44093
        • Chu De Nantes
      • Paris, France, 75012
        • Hopital Saint Antoine
      • Paris, France, 75015
        • Hopital Necker
      • Paris, France, 75013
        • Hopital de la Pitie Salpetriere
      • Paris, France, 75475
        • Hôpital St Louis
      • Paris, France, 75231
        • Institut Curie
      • Pierre-benite, France, 69310
        • CHU Lyon Sud
      • Poitiers, France, 86021
        • CHU de Poitiers
      • Reims, France, 51092
        • Hopital Robert Debre
      • Rennes, France, 35033
        • Hopital Pontchaillou
      • Rouen, France, 76038
        • Centre Henri Becquerel
      • Saint-Cloud, France, 92211
        • Hôpital René Huguenin
      • Vandoeuvre-les-nancy, France, 54511
        • CHU Brabois
      • 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 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Patients with follicular lymphoma, (WHO) grade 1, 2 or 3a with at least one of the following signs requiring initiation of treatment:

    • Bulky disease according to the GELF criteria: nodal or extra-nodal mass >7cm in its greater diameter
    • B symptoms
    • Elevated serum (LDH) or beta 2-microglobulin
    • Involvement of at least 3 nodal sites (each >3cm)
    • Symptomatic spleen enlargement
    • Compressive syndrome
    • Pleural or peritoneal effusion
  • Aged from 18 to 70 years
  • WHO performance status 0, 1 or 2
  • Signed inform consent
  • Life expectancy of ≥ 90 days (3 months).
  • Females of childbearing potential (FCBP)† must have a negative serum or urine pregnancy test with a sensitivity of at least 25 mIU/mL not more than 3 days from the start of study drug and must either commit to continued abstinence from heterosexual intercourse (and confirmed on a monthly basis) or begin one effective method of birth control, at least four weeks before she starts taking lenalidomide, and maintain that method throughout the entire duration of study drug therapy (including dose interruptions), and for four weeks after the end of study treatment with lenalidomide, even if she has amenorrhea. FCBP must also agree to pregnancy testing at least every three weeks and must be counseled at a minimum of every three weeks about pregnancy precautions and risks of fetal exposure.
  • Men must agree not to father a child and agree to use a condom throughout study drug therapy, during any dose interruption, and for one week after cessation of study drug therapy, if their partner is pregnant or of child bearing potential. Men must also agree not to donate semen during study drug therapy and for one week after end of study drug therapy. Men must be counseled at a minimum of every 4 weeks about pregnancy precautions and risks of fetal exposure.
  • All subjects must abstain from donating blood while taking study drug therapy and for one week following discontinuation of study drug therapy.

  • Agree not to share study drug with another person and to return all unused study drug to the investigator.

    • A female patient is considered to have childbearing potential unless she meets at least one of the following criteria 1) Age ≥ 50 years and naturally amenorrhoeic for ≥ 1 year (amenorrhoea following cancer therapy does not rule out childbearing potential); or 2) Premature ovarian failure confirmed by a specialist gynaecologist or 3) Previous bilateral salpingo-oophorectomy (BSO), or hysterectomy, or 4) XY genotype, turner syndrome, uterine agenesis.

Exclusion Criteria:

  • Previous treatment with immunotherapy or chemotherapy:

    • Chlorambucil or Cyclophosphamide per os alone during less than 6 months, if stopped more than one year before inclusion
    • Rituximab alone during less than three months, if stopped more than one year before inclusion
  • Previous radiotherapy except if localized to one lymph node area
  • Other type of lymphomas: Burkitt, T cell, lymphocytic, CD 20 negative
  • Central nervous system or meningeal involvement
  • Contraindication to any drug contained in the chemotherapy regimen
  • (HIV) disease, active hepatitis B or C
  • Any serious active disease or co-morbid medical condition (according to investigator's decision)

  • 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).
    • 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.
  • Calculated creatinine clearance (Cockcroft-Gault formula) of < 50 mL /min
  • 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
  • Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
  • Pregnant or lactating females.
  • Prior ≥ Grade 3 allergic reaction/hypersensitivity to thalidomide.
  • Prior ≥ Grade 3 rash or any desquamating (blistering) rash while taking thalidomide.
  • Subjects with ≥ Grade 2 neuropathy.
  • Prior use of lenalidomide.
  • Use of any standard or experimental anti-cancer drug therapy within 28 days of the initiation (Day 1) of study drug therapy.

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lenalidomide dose 25 mg
Drug: Lenalidomide and R-CHOP
Lenalidomide dose administered orally during 14 days in combination with 6 courses of fixed doses of R-CHOP 21.
Other Names:
  • R2-CHOP2

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Complete Response Rate (CR+CRu)
Time Frame: at the end of complete treatment, average of 24 weeks
at the end of complete treatment, average of 24 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall survival
Time Frame: from the date of inclusion, average of 6 years
from the date of inclusion, average of 6 years
Duration of response
Time Frame: from the date of first documentation of a response, average of 24 weeks
from the date of first documentation of a response, average of 24 weeks

Collaborators and Investigators

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

Sponsor

The Lymphoma Academic Research Organisation

Collaborators

Centre Henri Becquerel

Investigators

  • Principal Investigator: Hervé TILLY, Professeur, 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

Helpful Links

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

December 1, 2010

Primary Completion (Actual)

July 1, 2013

Study Completion (Actual)

November 1, 2015

Study Registration Dates

First Submitted

July 4, 2011

First Submitted That Met QC Criteria

July 12, 2011

First Posted (Estimated)

July 13, 2011

Study Record Updates

Last Update Posted (Actual)

December 5, 2023

Last Update Submitted That Met QC Criteria

December 4, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R2-CHOP2

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.

Clinical Trials on Follicular Lymphoma

Clinical Trials on Lenalidomide and R-CHOP

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Saint Lucia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe