Lenalidomide and Obinutuzumab for Previously Untreated CLL

This is an interventional treatment trial for Chronic Lymphocytic Leukemia focused on measuring cancer, lenalidomide, obinutuzumab, CLL Read More

• Main Inclusion Criteria:

  1. Clinical and phenotypic verification of B cell CLL or SLL and measurable disease.
  2. Prior therapy: no prior CLL therapy.
  3. Patients must have progressive disease based on 2008 iwCLL definition with one of the following:
• Symptomatic or progressive splenomegaly
• Symptomatic lymph nodes, nodal clusters, or progressive lymphadenopathy
• Progressive anemia (hemoglobin ≤ 11 g/dL)
• Progressive thrombocytopenia (platelets ≤ 100 x 109/L)
• Weight loss > 10% body weight over the preceding 6 month period
• Fatigue attributable to CLL
• Fever or night sweats for > 2 weeks without evidence of infection
• Progressive lymphocytosis with an increase of > 50% over a 2-month period or an anticipated doubling time of less than 6 months.
• Able to take aspirin (81mg or 325mg) daily, warfarin, low molecular weight heparin, or equivalent anticoagulation as prophylactic medication.
• All study participants must be registered into the mandatory Revlimid REMS program, and be willing and able to comply with the requirements of REMS.
• Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL within 10 - 14 days prior to and again within 24 hours prior to starting Revlimid and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control.
• Females of reproductive potential must adhere to the scheduled pregnancy testing as required in the Revlimid REMS program.
• ECOG performance status of 0-2.
• Adequate hematologic function
• Adequate renal function
• Adequate hepatic function

Exclusion Criteria:

• Pregnant or breast-feeding women will not be entered on this study due to risks of fetal and teratogenic adverse events as seen in animal/human studies. Women for child-bearing age must obtain a pregnancy test and pregnant or breast feeding females are excluded.
• Known hypersensitivity to thalidomide or lenalidomide (if applicable), including development of erythema nodosum or a desquamating rash while taking thalidomide or similar drugs.
• Deep vein thrombosis or superficial thrombophlebitis of any cause on current anticoagulation therapy at the time of screening.
• Patients who are currently receiving another investigational agent are excluded.
• Current infection requiring parenteral antibiotics.
• Known seropositive for or active viral infection with human immunodeficiency virus (HIV); or known active infection with hepatitis B virus (HBV) or hepatitis C virus (HCV) based on detectable viral load. Patients who are seropositive because of hepatitis B virus vaccine or passive immunization by intravenous immunoglobulin (IVIG) are eligible.
• Active malignancy within the previous 2 years (other than completely resected non-melanoma skin cancer or carcinoma in situ).
• Known central nervous system (CNS) involvement by malignancy.
• Untreated autoimmunity such as autoimmune hemolytic anemia, or immune thrombocytopenia.
• Insufficient recovery from surgical-related trauma or wound healing.
• Impaired cardiac function