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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by Lymphoma Study Association.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Lymphoma Study Association
ClinicalTrials.gov Identifier:
NCT00901615
First received: May 13, 2009
Last updated: March 3, 2011
Last verified: March 2011
  Purpose

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: Endpoint Classification: Safety/Efficacy Study
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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Complete response rate and Overall response rate at the end of treatment [ Time Frame: 3 months after the end of treatment ] [ Designated as safety issue: No ]
  • Complete and Overall response rates after induction [ Time Frame: at the end of third cycle of treatment (between Day 56 and Day 63) ] [ Designated as safety issue: No ]
  • Progression-Free Survival and Overall survival [ Time Frame: from the date of inclusion ] [ Designated as safety issue: No ]
  • Duration of response [ Time Frame: from the date of first documentation of a response ] [ Designated as safety issue: No ]
  • Collection of adverse events [ Time Frame: from the date of informed consent signature to end of treatment evaluation ] [ Designated as safety issue: Yes ]

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier: NCT00901615

Locations
France
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
Investigators
Principal Investigator: Hervé TILLY, Prof Lymphoma Study Association
  More Information

Additional Information:
GELA  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: GELA-Recherche Clinique (GELARC), Yvain Robreau
ClinicalTrials.gov Identifier: NCT00901615     History of Changes
Other Study ID Numbers: R2CHOP-1
Study First Received: May 13, 2009
Last Updated: March 3, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Lymphoma Study Association:
lymphoma
lenalidomide
gela

Additional relevant MeSH terms:
Lymphoma
Lymphoma, B-Cell
Lymphoma, B-Cell, Marginal Zone
Lymphoma, Follicular
Lymphoma, Large B-Cell, Diffuse
Lymphoma, Mantle-Cell
Lymphoma, Non-Hodgkin
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Lenalidomide
Thalidomide
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Anti-Bacterial Agents
Anti-Infective Agents
Antineoplastic Agents
Growth Inhibitors
Growth Substances
Immunologic Factors
Immunosuppressive Agents
Leprostatic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014