A Phase 3 Open Label Randomized Study to Compare the Efficacy and Safety of Rituximab Plus Lenalidomide (CC-5013) Versus Rituximab Plus Chemotherapy Followed by Rituximab in Subjects With Previously Untreated Follicular Lymphoma

Prior treatment

• Patients taking corticosteroids during the last 4 weeks, unless administered at a dose equivalent to \< 10 mg/day prednisone (over these 4 weeks).
• Major surgery (excluding lymph node biopsy) within 28 days prior to signing informed consent.
• Prior use of lenalidomide.

Other illness

• Known Seropositive for or active viral infection with hepatitis B virus (HBV), hepatitis C virus (HCV)or human immunodeficiency virus (HIV).
• Known sensitivity or allergy to murine products.
• Presence or history of CNS involvement by lymphoma.

Lab values

• serum aspartate transaminase (AST/SGOT) or alanine transaminase (ALT/SGPT) \> 3x upper limit of normal (ULN), except in patients with documented liver or pancreatic involvement by lymphoma
• total bilirubin \> 2.0 mg/dl (34 µmol/L) except in cases of Gilberts Syndrome and documented liver involvement by lymphoma
• creatinine clearance of \< 30 mL/min
• Any condition, including the presence of laboratory abnormalities, which places the patient at unacceptable risk if he/she were to participate in the study, or which confounds the ability to interpret data from the study.

Age

• Prior history of malignancies, other than follicular lymphoma, unless the patient has been free of the disease for ≥ 10 years.

Other

• Clinical evidence of transformed lymphoma by investigator assessment or Grade 3b follicular lymphoma.
• Life expectancy \< 6 months.
• Neuropathy \> Grade 1.
• Patients who are at a high risk for a thromboembolic event and are not willing to take venous thromboembolic (VTE) prophylaxis.
• Pregnant or lactating females.

• Histologically confirmed CD20+ follicular lymphoma grade 1, 2 or 3a
• Have no prior systemic treatment for lymphoma.
• Must be in need of treatment
• Bi-dimensionally measurable disease with at least one mass lesion \> 2 cm that was not previously irradiated.
• Stage II, III or IV disease.
• Must be ≥ 18 years and sign an informed consent.
• Performance status ≤ 2 on the ECOG scale.
• Adequate hematological function (unless abnormalities are related to lymphoma infiltration of the bone marrow)
• Willing to follow pregnancy precautions