Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2011 by Lymphoma Study Association.
Recruitment status was:  Active, not recruiting
Information provided by:
Lymphoma Study Association Identifier:
First received: May 13, 2009
Last updated: March 3, 2011
Last verified: March 2011
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).

Condition Intervention Phase
Lymphoma, Large B-Cell, Diffuse
Follicular Lymphoma
Mantle Cell Lymphoma
Marginal Zone B-Cell Lymphoma
Drug: Lenalidomide and R-CHOP
Phase 1
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase IB 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 Lymphoma Study Association:

Primary Outcome Measures:
  • Incidence of Dose Limiting Toxicities [ Time Frame: 42 days ]

Secondary Outcome Measures:
  • Complete response rate and Overall response rate at the end of treatment [ Time Frame: 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) ]
  • Progression-Free Survival and Overall survival [ Time Frame: from the date of inclusion ]
  • Duration of response [ Time Frame: from the date of first documentation of a response ]
  • Collection of adverse events [ Time Frame: from the date of informed consent signature to end of treatment evaluation ]

Estimated Enrollment: 30
Study Start Date: January 2009
Estimated Study Completion Date: January 2012
Estimated Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Escalating Lenalidomide dose from 2.5 to 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: REVLIMID

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.

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  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 identifier: NCT00901615

CHU de Dijon
Dijon, France, 21034
CHRU Lille
Lille, France, 59037
CHU Lyon Sud
Pierre Benite, France, 69310
Centre Henri Becquerel
Rouen, France, 76038
CHU Brabois
Vandoeuvre les Nancy, France, 54511
Sponsors and Collaborators
Lymphoma Study Association
Principal Investigator: Hervé TILLY, Prof Lymphoma Study Association
  More Information

Additional Information:
GELA  This link exits the site

Responsible Party: GELA-Recherche Clinique (GELARC), Yvain Robreau Identifier: NCT00901615     History of Changes
Other Study ID Numbers: R2CHOP-1
Study First Received: May 13, 2009
Last Updated: March 3, 2011

Keywords provided by Lymphoma Study Association:

Additional relevant MeSH terms:
Lymphoma, Follicular
Lymphoma, B-Cell
Lymphoma, Mantle-Cell
Lymphoma, B-Cell, Marginal Zone
Lymphoma, Large B-Cell, Diffuse
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
Immunosuppressive Agents
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents processed this record on April 21, 2017