Lenalidomide and R-CHOP in B-cell Lymphoma

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.