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

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: NCT00901615
Recruitment Status : Completed
First Posted : May 14, 2009
Last Update Posted : August 23, 2018
Information provided by (Responsible Party):
Lymphoma Study Association

Brief Summary:
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 or disease Intervention/treatment Phase
Lymphoma, Large B-Cell, Diffuse Follicular Lymphoma Mantle Cell Lymphoma Marginal Zone Lymphoma Drug: Lenalidomide and R-CHOP Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 108 participants
Intervention Model: Single Group Assignment
Masking: None (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
Actual Study Start Date : January 6, 2009
Actual Primary Completion Date : November 19, 2010
Actual Study Completion Date : November 23, 2015

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 Name: REVLIMID

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

Secondary Outcome Measures :
  1. Complete response rate and Overall response rate at the end of treatment [ Time Frame: 3 months after the end of treatment ]
  2. Complete and Overall response rates after induction [ Time Frame: at the end of third cycle of treatment (between Day 56 and Day 63) ]
  3. Progression-Free Survival and Overall survival [ Time Frame: 7 years ]
  4. Duration of response [ Time Frame: 7 years ]
  5. Collection of adverse events [ Time Frame: 6 months ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
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.

Information from the National Library of Medicine

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): NCT00901615

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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
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Principal Investigator: Hervé TILLY, Prof Lymphoma Study Association

Additional Information:
GELA  This link exits the site

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Responsible Party: Lymphoma Study Association Identifier: NCT00901615     History of Changes
Other Study ID Numbers: R2CHOP-1
First Posted: May 14, 2009    Key Record Dates
Last Update Posted: August 23, 2018
Last Verified: August 2018
Keywords provided by Lymphoma Study Association:
Additional relevant MeSH terms:
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Lymphoma, Mantle-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents