Imatinib Mesylate After a Donor Stem Cell Transplant in Treating Patients With Philadelphia Chromosome-Positive Leukemia

• Status: Completed
• Trial end date: 2007-08-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Imatinib mesylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving imatinib mesylate after a donor stem cell transplant may prevent the recurrence of Philadelphia chromosome-positive leukemia.

PURPOSE: This phase I/II trial is studying the side effects of giving imatinib mesylate after a donor stem cell transplant and to see how well it works in treating patients with Philadelphia chromosome-positive leukemia.

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

Details

• Lead Sponsor: Fred Hutchinson Cancer Research Center
• Treatments: Imatinib Mesylate

Criteria

DISEASE CHARACTERISTICS:

• Diagnosis of 1 of the following:

• Acute lymphoblastic leukemia or chronic myeloid leukemia (CML) characterized by p^190 and/or p^210 bcr/abl gene rearrangement

• Accelerated or blastic phase CML

• CML in second or greater chronic phase

• No imatinib mesylate-resistant leukemia

• Planned allogeneic hematopoietic stem cell transplantation

• Availability of an appropriately matched related or unrelated donor

• Autologous or nonmyeloablative transplantation is not allowed

• None of the following within 4 days after the date of neutrophil engraftment*:

• More than 5% marrow blasts

• Circulating peripheral blood leukemic blasts

• Aberrant antigen expression on marrow myeloblasts ≥ 1% by multidimensional flow cytometric assay

• Presence of bcr/abl in > 5% of marrow interphase nuclei by fluorescent in situ hybridization

• More than 1 of 20 Philadelphia chromosome-positive marrow metaphases

• CNS involvement by leukemia NOTE: *The date of neutrophil engraftment is defined as the second consecutive day at which the peripheral blood absolute neutrophil count exceeds 500/mm3

PATIENT CHARACTERISTICS:

Performance status

• Not specified

Life expectancy

• At least 2 months

Hematopoietic

• See Disease Characteristics

• Absolute neutrophil count ≥ 1,200/mm^3 (use of filgrastim [G-CSF] allowed)

Hepatic

• Not specified

Renal

• Not specified

Other

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No known imatinib mesylate hypersensitivity

• No other disease that severely limits life expectancy

PRIOR CONCURRENT THERAPY:

Biologic therapy

• See Disease Characteristics