B cell lymphoma
Conditions
Interventions
Trade Name: REVLIMID
Pharmaceutical Form: Capsule, hard
Sponsors
GELARC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Phase IB: Patients with one of the following B-cell Lymphoma, CD 20 positive: o Mantle cell, Marginal zone, follicular o Histological transformation from low grade to high grade o Diffuse large B cell • Phase II: Patients with follicular lymphoma, WHO grade 1, 2 or 3a with at least one of the following signs requiring initiation of treatment: o Bulky disease according to the GELF criteria: nodal or extra-nodal mass >7cm in its greater diameter o B symptoms o Elevated serum LDH or beta 2-microglobulin o Involvement of at least 3 nodal sites (each >3cm) o Symptomatic spleen enlargement o Compressive syndrome o 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 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Previous treatment with immunotherapy or chemotherapy except: o Chlorambucil or Cyclophosphamide per os alone during less than 6 months, if stopped more than one year before inclusion o 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. o Absolute neutrophil count (ANC) 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the Phase Ib part of the study is to determine the recommended dose (RD) of lenalinomide (Revlimid) when administered in association with R-CHOP. The primary objective of the Phase II part of the study is to assess the efficacy of the association of Revlimid and R-CHOP in a population of patients with follicular lymphoma as measured by the response rate at the end of treatment.;Secondary Objective: The secondary objectives of this study are: • To assess the safety of the association, • To assess the efficacy of the association: overall response rate and complete response rate, progression free survival, response duration and overall survival.;Primary end point(s): The primary endpoint for the phase IB part of the study is the determination of the Recommended Dose of lenalidomide (Revlimid) in combination with R-CHOP regimen. Therefore, primary analysis will be based on safety parameters and particulary on incidence of DLTs as defined in section 7.3. Frequency of patients with DLT during the first 2 cycles of R2-CHOP will be reported by dose level. Toxicities related to study regimen and occurring during the assessment period will be reviewed to confirm if they were dose limiting according to protocol and initial patient condition (pre-existing signs and symptoms, medical history). A listing will provide the description of DLTs observed by dose level. The primary endpoint for the phase II part of the study is the Complete Response Rate (CR+CRu) at the end of treatment. Assessment of response will be based on the International Workshop to Standardize Response criteria for NHL (Criteria for evaluation of response in Non-Hodgkin’s lymphoma (Cheson, 1999, section 11.2.1). Response at the end of treatment will be assessed at the end of complete treatment if patient received all planned cycles or at withdrawal. Patient without response assessment (due to whatever reason) will be considered as non-responder. A descriptive analysis w | — |
Countries
France
Outcome results
None listed