Overview

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.