Bendamustine and Rituximab (BR) as Induction and Maintenance in Relapsed and Refractory Chronic Lymphocytic Leukemia

Inclusion Criteria:

* Confirmed diagnosis of CD20-positive CLL that meets the iwCLL criteria (Hallek et al, 2008).
* Relapsed or refractory status of disease after at least one prior chemotherapy regimen.
* ECOG performance status of 0-2 at study entry
* Patients have not received prior therapy with bendamustine
* Prior therapy with rituximab is permitted, even in the setting of rituximab refractory disease.

For inclusion in the research part of maintenance therapy (phase B):

* At least a partial response (PR or better; Hallek et al, 2008) must be achieved after induction of BR (phase A)

Exclusion Criteria:

* Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent document or complying with the protocol treatment.
* Pregnant or breast-feeding females.
* Known to be positive for human immunodeficiency virus (HIV) or infectious hepatitis (type B or C).
* Patients are not eligible if there is a prior history or current evidence of central nervous system or leptomeningeal involvement.
* Richter syndrome or chronic prolymphocytic leukemia.
* Uncontrolled autoimmune hemolytic anemia or thrombocytopenia.
* Concurrent use of other anti-cancer agents or treatments.
* Laboratory test results within these ranges: ANC ≤ 1000/μL, Platelet count ≤ 75,000/μL.
* Total bilirubin 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) ≥ 3 x ULN, and/or serum alkaline phosphatase ≥ 5 X ULN.
* New York Heart Association class 3-4 heart failure.