Lenalidomide and R-CHOP in B-cell Lymphoma

NCT ID: NCT00901615

Last Updated: 2018-08-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 108 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-06
• Study Completion Date: 2015-11-23

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).

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.

Conditions

Lymphoma, Large B-Cell, Diffuse; Follicular Lymphoma; Mantle Cell Lymphoma; Marginal Zone Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Lenalidomide and R-CHOP

Escalating Lenalidomide dose from 2.5 to 25 mg Lenalidomide and R-CHOP

Group Type: EXPERIMENTAL

Lenalidomide and R-CHOP

Intervention Type: DRUG

Lenalidomide dose administered orally during 14 days in combination with 6 courses of fixed doses of R-CHOP 21.

Interventions

Lenalidomide and R-CHOP

Lenalidomide dose administered orally during 14 days in combination with 6 courses of fixed doses of R-CHOP 21.

Intervention Type: DRUG

Other Intervention Names

REVLIMID

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lymphoma Study Association

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hervé TILLY, Prof

Role: PRINCIPAL_INVESTIGATOR

Lymphoma Study Association

Locations

CHU de Dijon

Dijon, , France

CHRU Lille

Lille, , France

CHU Lyon Sud

Pierre-Bénite, , France

Centre Henri Becquerel

Rouen, , France

CHU Brabois

Vandœuvre-lès-Nancy, , France

Countries

France

Related Links

http://www.gela.org

GELA

Other Identifiers

R2CHOP-1

Identifier Type: -

Identifier Source: org_study_id