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A Phase I-II Trial of Gleevec (Imatinib Mesylate) in Combination With Chlorambucil in Previously Treated Chronic Lymphocytic Leukemia (CLL) Patients

Phase 1/Phase 2
18 Years
Not Enrolling
Chronic Lymphocytic Leukemia

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Trial Information

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.

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

- 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

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

- 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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Measure number of patients at maximum tolerated dose of Gleevec in combination with chlorambucil

Outcome Time Frame:

1 month

Safety Issue:


Principal Investigator

Sarit Assouline, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Jewish General Hospital


Canada: Health Canada

Study ID:




Start Date:

October 2005

Completion Date:

April 2009

Related Keywords:

  • Chronic Lymphocytic Leukemia
  • CLL
  • chronic lymphocytic leukemia
  • leukemia
  • gleevec
  • chlorambucil
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid