Study of OBINUTUZUMAB Combined to LENALIDOMIDE for the Treatment of Relapsed/Refractory Follicular and Aggressive B-cell Lymphoma

Exclusion Criteria

• •Previous treatment with obinutuzumab or lenalidomide
• •Known CD20 negative status at relapse/progression. Biopsy at relapse/progression is recommended but not mandatory
• •Central nervous system or meningeal involvement by lymphoma
• •Contraindication to any drug contained in the study treatment regimen
• •Known HIV or HTLV-1 infection, positive serology to HB surface antigen \[HBsAg\] or total HB core antibody \[anti-HB-c\]) and Hepatitis C (Hepatitis C virus \[HCV\] antibody)
• •Any serious active disease or co-morbid medical condition (such as New York Heart Association Class II or IV cardiac disease, severe arrhythmia, myocardial infarction within the last 6 months, unstable arrhythmias, or unstable angina) or pulmonary disease (including obstructive pulmonary disease and history of bronchospasm or other according to investigator's decision)
• •Any of the following laboratory abnormalities unless secondary to underlying lymphoma:
• •* Absolute neutrophil count (ANC) \< 1,500 cells/mm3 (1.5 x 109/L).
• •* Platelet count \< 100,000/mm3 (100 x 109/L) unless due to lymphoma for phase II part.
• •* Serum SGOT/AST or SGPT/ALT 3.0 x upper limit of normal (ULN) unless disease involvement.
• •* Serum total bilirubin \> 2.0 mg/dL (34 μmol/L), except if disease related or in case of Gilbert syndrome
• •* Calculated creatinine clearance (Cockcroft-Gault formula or MDRD) of \< 50 mL /min. For phase II part of the study, patients with calculated creatinine clearance between 30 and 50ml/min can be included and lenalidomide dose will be adjusted as follows (10mg once daily)
• •Prior history of malignancies other than lymphoma unless the subject has been free of the disease for ≥ 5 years
• •Any serious medical condition, laboratory abnormality (other than mentioned above), 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.
• •Use of any standard or experimental anti-cancer drug therapy within 28 days of the initiation (Day 1) of study drug therapy
• •Patients taking corticosteroids during 4 weeks before inclusion, unless administered at a dose equivalent to ≤ 10 mg/day prednisone (over these 4 weeks)
• •Prior history of Progressive Multifocal Leukoencephalopathy (PML)