Lenalidomide and R-CHOP in B-cell Lymphoma (R2CHOP-1)

August 21, 2018 updated by: Lymphoma Study Association

A Phase IB 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 determine the recommended dose (RD) of lenalidomide (Revlimid) when administered in association with R-CHOP (rituximab (R), cyclophosphamide, doxorubicin, vincristine and prednisone).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study is a dose escalation study of lenalidomide (Revlimid) administered orally during 14 days in combination with fixed doses of rituximab (R), cyclophosphamide, doxorubicin, vincristine and prednisone (CHOP) administered every 3 weeks (R-CHOP 21) in patients with B-cell lymphoma.

Study Type

Interventional

Enrollment (Actual)

108

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
      • Dijon, France, 21034
        • CHU de Dijon
      • Lille, France, 59037
        • CHRU Lille
      • Pierre Benite, France, 69310
        • CHU Lyon Sud
      • 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

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with one of the following B-cell Lymphoma, CD 20 positive:

    • Mantle cell, Marginal zone, follicular
    • Histological transformation from low grade to high grade
    • Diffuse large B cell
  • 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 or begin one acceptable method of birth control, at least 4 weeks before she starts taking lenalidomide. FCBP must also agree to monthly pregnancy testing and must be counseled at a minimum of every 4 weeks about pregnancy precautions and risks of fetal exposure.

  • Men must agree not to father a child and agree to use a condom if his partner is of child bearing potential. Men must also be counseled at a minimum of every 4 weeks about pregnancy precautions and risks of fetal exposure.

    • † 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, or hysterectomy, or 4) XY genotype, turner syndrome, uterine agenesis.

Exclusion Criteria:

  • Previous treatment with immunotherapy or chemotherapy except:

    • 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 and R-CHOP
Escalating Lenalidomide dose from 2.5 to 25 mg Lenalidomide and R-CHOP
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:
  • REVLIMID

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
Time Frame
Duration of response
Time Frame: 7 years
7 years
Complete response rate and Overall response rate at the end of treatment
Time Frame: 3 months after the end of treatment
3 months after the end of treatment
Complete and Overall response rates after induction
Time Frame: at the end of third cycle of treatment (between Day 56 and Day 63)
at the end of third cycle of treatment (between Day 56 and Day 63)
Progression-Free Survival and Overall survival
Time Frame: 7 years
7 years
Collection of adverse events
Time Frame: 6 months
6 months

Collaborators and Investigators

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

Sponsor

Lymphoma Study Association

Investigators

  • Principal Investigator: Hervé TILLY, Prof, Lymphoma Study Association

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)

January 6, 2009

Primary Completion (Actual)

November 19, 2010

Study Completion (Actual)

November 23, 2015

Study Registration Dates

First Submitted

May 13, 2009

First Submitted That Met QC Criteria

May 13, 2009

First Posted (Estimate)

May 14, 2009

Study Record Updates

Last Update Posted (Actual)

August 23, 2018

Last Update Submitted That Met QC Criteria

August 21, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R2CHOP-1

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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