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

OBJECTIVES:

Primary

• Determine the safety of adjuvant imatinib mesylate after allogeneic hematopoietic stem cell transplantation (AHSCT) in patients with high-risk Philadelphia chromosome-positive leukemia.

Secondary

• Determine the bcr/abl transcript load during the first 90 days after AHSCT in patients treated with this drug from the time of engraftment.
• Determine the 1-year survival of patients treated with this drug.

OUTLINE: This is an open-label, pilot, multicenter study.

Beginning within 14-30 days after allogeneic stem cell transplantation, patients receive oral imatinib mesylate once daily until 1 year after transplantation. Treatment continues in the absence of unacceptable toxicity or disease progression.

Patients are followed for survival.

PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.

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