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

Sponsor
The Lymphoma Academic Research Organisation (Other)
Overall Status
Completed
CT.gov ID
NCT01393756
Collaborator
Centre Henri Becquerel (Other)
80
Enrollment
24
Locations
1
Arm
59
Duration (Months)
3.3
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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
  • Drug: Lenalidomide and R-CHOP
 Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
80 participants
Allocation:
N/A
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 :
Dec 1, 2010
Actual Primary Completion Date :
Jul 1, 2013
Actual Study Completion Date :
Nov 1, 2015

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Complete Response Rate (CR+CRu) [at the end of complete treatment, average of 24 weeks]

    Secondary Outcome Measures

    1. Overall survival [from the date of inclusion, average of 6 years]

    2. Duration of response [from the date of first documentation of a response, average of 24 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Institut Bergonié Bordeaux France 33076
    2 Polyclinique Bordeaux Nord Aquitaine Bordeaux France 33077
    3 CHU Estaing Clermont ferrand France 63000
    4 Hôpital Henri Mondor Creteil France 94010
    5 CHU de DIJON Dijon France 21034
    6 Chru Lille Lille France 59037
    7 Centre Léon Bérard Lyon France 69373
    8 Institut Paoli Calmettes Marseille France 13273
    9 Hôpital Notre Dame de Bon Secours Metz France 57038
    10 Hôpital Saint Eloi Montpellier France 34295
    11 CHU de NANTES Nantes France 44093
    12 Hôpital Saint Antoine Paris France 75012
    13 Hôpital de la Pitié Salpétrière Paris France 75013
    14 Hôpital Necker Paris France 75015
    15 Institut Curie Paris France 75231
    16 Hôpital St Louis Paris France 75475
    17 Chu Lyon Sud Pierre-benite France 69310
    18 CHU de Poitiers Poitiers France 86021
    19 Hôpital Robert Debré Reims France 51092
    20 Hôpital Pontchaillou Rennes France 35033
    21 Centre Henri BECQUEREL Rouen France 76038
    22 Hôpital René Huguenin Saint-Cloud France 92211
    23 Chu Brabois Vandoeuvre-les-nancy France 54511
    24 Institut Gustave Roussy Villejuif France 94805

    Sponsors and Collaborators

    • The Lymphoma Academic Research Organisation
    • Centre Henri Becquerel

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    The Lymphoma Academic Research Organisation
    ClinicalTrials.gov Identifier:
    NCT01393756
    Other Study ID Numbers:
    • (R2-CHOP2)
    First Posted:
    Jul 13, 2011
    Last Update Posted:
    Jul 26, 2021
    Last Verified:
    Jul 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:
    Lymphoma
    Lymphoma, Follicular
    Lenalidomide

    Study Results

    No Results Posted as of Jul 26, 2021