Spots Global Cancer Trial Database for Dose Escalation Study of Gleevec and Chlorambucil in Previously Treated Chronic Lymphocytic Leukemia Patients
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Trial Identification
Brief Title: Dose Escalation Study of Gleevec and Chlorambucil in Previously Treated Chronic Lymphocytic Leukemia Patients
Official Title: A Phase I-II Trial of Gleevec (Imatinib Mesylate) in Combination With Chlorambucil in Previously Treated Chronic Lymphocytic Leukemia (CLL) Patients
Study ID: NCT00558961
Conditions
Interventions
Study Description
Brief Summary: The purpose of this study is to determine maximum tolerated dose of Gleevec in combination with Chlorambucil in previously treated CLL patients.
Detailed Description: 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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Charles Lemoyne Hospital, Greenfield Park, Quebec, Canada
Jewish General Hospital, Montreal, Quebec, Canada
Contact Details
Name: Sarit Assouline, MD
Affiliation: Jewish General Hospital
Role: PRINCIPAL_INVESTIGATOR
Name: Lawrence Panasci, MD
Affiliation: Jewish General Hospital
Role: STUDY_DIRECTOR
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