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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01393756
Recruitment Status : Completed
First Posted : July 13, 2011
Last Update Posted : February 17, 2016
Centre Henri Becquerel
Information provided by (Responsible Party):
The Lymphoma Academic Research Organisation

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Follicular Lymphoma Drug: Lenalidomide and R-CHOP Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase Ib/II Study of Escalating Doses of Revlimid in Association With R-CHOP (R2-CHOP) in the Treatment of B-cell Lymphoma
Study Start Date : December 2010
Actual Primary Completion Date : July 2013
Actual Study Completion Date : November 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

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 Name: R2-CHOP2

Primary Outcome Measures :
  1. Complete Response Rate (CR+CRu) [ Time Frame: at the end of complete treatment, average of 24 weeks ]

Secondary Outcome Measures :
  1. Overall survival [ Time Frame: from the date of inclusion, average of 6 years ]
  2. Duration of response [ Time Frame: from the date of first documentation of a response, average of 24 weeks ]

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01393756

Institut Bergonié
Bordeaux, France, 33076
Polyclinique Bordeaux Nord Aquitaine
Bordeaux, France, 33077
CHU Estaing
Clermont ferrand, France, 63000
Hôpital Henri Mondor
Creteil, France, 94010
Dijon, France, 21034
Chru Lille
Lille, France, 59037
Centre Léon Bérard
Lyon, France, 69373
Institut Paoli Calmettes
Marseille, France, 13273
Hôpital Notre Dame de Bon Secours
Metz, France, 57038
Hôpital Saint Eloi
Montpellier, France, 34295
Nantes, France, 44093
Hôpital Saint Antoine
Paris, France, 75012
Hôpital de la Pitié Salpétrière
Paris, France, 75013
Hôpital Necker
Paris, France, 75015
Institut Curie
Paris, France, 75231
Hôpital St Louis
Paris, France, 75475
Chu Lyon Sud
Pierre-benite, France, 69310
CHU de Poitiers
Poitiers, France, 86021
Hôpital Robert Debré
Reims, France, 51092
Hôpital Pontchaillou
Rennes, France, 35033
Centre Henri BECQUEREL
Rouen, France, 76038
Hôpital René Huguenin
Saint-Cloud, France, 92211
Chu Brabois
Vandoeuvre-les-nancy, France, 54511
Institut Gustave Roussy
Villejuif, France, 94805
Sponsors and Collaborators
The Lymphoma Academic Research Organisation
Centre Henri Becquerel
Principal Investigator: Hervé TILLY, Professeur Lymphoma Study Association

Additional Information:
Responsible Party: The Lymphoma Academic Research Organisation Identifier: NCT01393756     History of Changes
Other Study ID Numbers: (R2-CHOP2)
First Posted: July 13, 2011    Key Record Dates
Last Update Posted: February 17, 2016
Last Verified: February 2016

Additional relevant MeSH terms:
Lymphoma, Follicular
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents