A Phase I-II Trial of Gleevec (Imatinib Mesylate) in Combination With Chlorambucil in Previously Treated Chronic Lymphocytic Leukemia (CLL) Patients
A recent study by Aloyz et al demonstrated a synergistic effect of imatinib on
chlorambucil-mediated cytotoxicity in CLL cells in vitro. Imatinib inhibits c-abl and
sensitizes cells to chlorambucil. The Phase I component of the study will determine the
maximum tolerated dose and recommended Phase II dose of Gleevec when used in combination
with chlorambucil. Once the maximum tolerated dose has been determined, a total of 16
patients will be enrolled in the Phase II component of the study. This study will determine
the dose limiting toxicities, pharmacokinetics and pharmacodynamics of Gleevec in
combination with chlorambucil.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Measure number of patients at maximum tolerated dose of Gleevec in combination with chlorambucil
1 month
No
Sarit Assouline, MD
Principal Investigator
Jewish General Hospital
Canada: Health Canada
CR0506PI
NCT00558961
October 2005
April 2009
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