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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Centre Henri Becquerel
Information provided by (Responsible Party):
The Lymphoma Academic Research Organisation
ClinicalTrials.gov Identifier:
NCT01393756
First received: July 4, 2011
Last updated: August 8, 2014
Last verified: August 2014
  Purpose

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 Intervention Phase
Follicular Lymphoma
Drug: Lenalidomide and R-CHOP
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by The Lymphoma Academic Research Organisation:

Primary Outcome Measures:
  • Complete Response Rate (CR+CRu) [ Time Frame: at the end of complete treatment, average of 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival [ Time Frame: from the date of inclusion, average of 6 years ] [ Designated as safety issue: No ]
  • Duration of response [ Time Frame: from the date of first documentation of a response, average of 24 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: December 2010
Estimated Study Completion Date: July 2015
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01393756

Locations
France
Institut Bergonié
Bordeaux, France, 33076
Polyclinique Bordeaux Nord Aquitaine
Bordeaux, France, 33077
CHU Estaing
Clermont ferrand, France, 63000
Hôpital Henri Mondor
Creteil, France, 94010
CHU de DIJON
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
CHU de NANTES
Nantes, France, 44093
Hôpital Necker
Paris, France, 75015
Hôpital Saint Antoine
Paris, France, 75012
Hôpital St Louis
Paris, France, 75475
Institut Curie
Paris, France, 75231
Hôpital de la Pitié Salpétrière
Paris, France, 75013
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
Investigators
Principal Investigator: Hervé TILLY, Professeur Lymphoma Study Association
  More Information

Additional Information:
No publications provided

Responsible Party: The Lymphoma Academic Research Organisation
ClinicalTrials.gov Identifier: NCT01393756     History of Changes
Other Study ID Numbers: (R2-CHOP2)
Study First Received: July 4, 2011
Last Updated: August 8, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

ClinicalTrials.gov processed this record on August 18, 2014