A Dose-Ranging Study of Bendamustine and Rituximab in Chronic Lymphocytic Leukemia Patients with Comorbidities and/or Renal Dysfunction
This is a non-randomized, open label, dose-ranging study of Bendamustine and Rituximab (BR)
in patients with previously untreated or relapsed/refractory Chronic Lymphocytic Leukemia
(CLL) who have multiple comorbidities with or without renal insufficiency. These agents are
FDA approved for this indication. However, full dose bendamustine is associated with
significant hematologic toxicity and a high rate of infectious complications in "unfit"
patients and patients with significantly impaired renal function. This study will attempt to
optimize and define adequate and safe treatment protocols for these patients with
comorbidities and/or renal dysfunction.
The study will accrue two independent patient cohorts which will follow a standard Phase I
design. Patients with CLL who have significant comorbidities with or without minor renal
dysfunction (CrCL>40 mL/min) will be accrued onto Cohort 1 of the study. Patients with
significant renal dysfunction (CrCL<40 mL/min) will be accrued onto Cohort 2. Once the
maximum tolerated dose (MTD) is determined, two expansion cohorts will be enrolled.
There will be a treatment period of up to six 28-day cycles. On C1D1 all qualifying
patients will provide samples for biomarker analysis. Six patients without renal
dysfunction and 6 to 9 patients with renal dysfunction will also provide samples for
bendamustine PK analysis.
Accrual of both patient cohorts will occur simultaneously and will take place at two
centers: Norris Cotton Cancer Center (NCCC) and Dana-Farber Cancer Institute (DFCI).
Coordination of accrual to the study cohorts will be centralized at NCCC by Dr. Alexey V.
View more details from ClinicalTrials.gov.
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Please Note: Any eligibility criteria noted are subject to change. Our research nurses can provide you with the most current eligibility and exclusion criteria. Any study involvement to be undertaken must ultimately be determined on an individual basis.