Phase II Study of Bendamustine and Rituximab Induction Chemoimmunotherapy With Maintenance Lenalidomide and Rituximab in Relapsed/Refractory CLL/SLL
- Histologically confirmed,CLL/SLL, documented relapsed or refractory disease after at
least one prior chemotherapy regimen.
- In cases of SLL, patients must have at least one bidimensionally measurable lesion at
least ≥1.5 cm measured in one dimension.
- ECOG performance status of 0-2 at study entry
- Laboratory test results within these ranges: ANC <=1500/μL, Platelet count <=
100,000/μL. Patients with ANC <1500/μL or plt <100,000/μL with splenomegaly or
extensive bone marrow involvement as the etiology for their cytopenias are eligible.
- creatinine clearance of >60 mL/min as determined by the Cockcroft-Gault calculation.
- Total bilirubin <= 2X upper limit laboratory normal (ULN). Patients with
non-clinically significant elevations of bilirubin due to Gilbert's disease are not
required to meet these criteria.
- Serum transaminases AST (SGOT) and ALT (SGPT) <=5x ULN, Serum alkaline phosphatase ≤5
- Disease free of prior malignancies for ≥ 2 years with the exception of basal or
squamous cell skin carcinoma, carcinoma "in situ" of the breast or cervix, or
localized prostate cancer (treated definitively with hormone therapy, radiotherapy,
- Patients may have received prior therapy with bendamustine or lenalidomide, but must
not have disease that is refractory to bendamustine or lenalidomide.
- Prior therapy with rituximab is permitted, even in the setting of rituximab
- Has received >5 lines of prior therapy for their disease. Re-treatment with an
identical regimen does not count as a new regimen.
- Any serious medical condition, laboratory abnormality, or psychiatric illness that
would prevent the subject from signing the informed consent form or comply with the
- Pregnant or breast feeding females. Lactating females must agree not to breast feed
while taking lenalidomide.
- Prior history or current evidence of central nervous system or leptomeningeal
- Use of any other experimental drug or therapy within 28 days of baseline.
- Known hypersensitivity to thalidomide.
- The development of erythema nodosum if characterized by a desquamating rash while
taking thalidomide or similar drugs.
- Known to be positive for HIV or infectious hepatitis, type B or C.