Dose Escalation Study of Gleevec and Chlorambucil in Previously Treated Chronic Lymphocytic Leukemia Patients

• Status: Terminated
• Trial end date: 2009-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine maximum tolerated dose of Gleevec in combination with Chlorambucil in previously treated CLL patients.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jewish General Hospital
• Collaborator: Novartis Pharmaceuticals
• Treatments: Chlorambucil; Imatinib Mesylate

Criteria

Inclusion Criteria:

• B-cell chronic lymphocytic leukemia (a) Rai stage 0-II with indication for treatment by NCI Working Group Criteria: or (b) Rai stage III or IV.

• Received a minimum of one prior chemotherapy regimen. Prior treatment with corticosteroids, immunotherapies, monoclonal antibodies or radiation therapy is permitted.

• White blood cell count > 25 x 10^9/L

• ECOG 0, 1,or 2.

• Adequate renal and hepatic function

• Platelets > 75 x 10^9/L, transfusion independent.

• Neutrophils > 1.0 x 10^9/L, transfusion independent

Exclusion Criteria:

• Documented prolymphocytic leukemia (PLL; prolymphocytes, 55% in blood)

• Active cardiovascular disease as defined by NYHA class III-IV categorization.

• Intercurrent illness or medical condition precluding safe administration of ribavirin.

• Concurrent use of chronic steroids, except as replacement therapy for adrenal insufficiency

• Known infection with HIV, Hepatitis B or C.

• Concurrent malignancy (other than resected basal or squamous cell skin cancers or in-situ carcinoma).

• Received any previous therapy for CLL within 28 days prior to study entry.