Leukemia
Conditions
Keywords
accelerated phase chronic myelogenous leukemia, blastic phase chronic myelogenous leukemia, childhood chronic myelogenous leukemia, chronic phase chronic myelogenous leukemia, Philadelphia chromosome positive chronic myelogenous leukemia, adult acute lymphoblastic leukemia in remission, childhood acute lymphoblastic leukemia in remission
Brief 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.
Detailed description
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.
Interventions
DRUGimatinib mesylate
PROCEDUREadjuvant therapy
Sponsors
Fred Hutchinson Cancer Center
Study design
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety at 90 days following transplant | — |
Secondary
| Measure | Time frame |
|---|---|
| BCR/ABL transcript load at 90 days following transplant | — |
| Standard management of progressive minimal residual disease at 90 days following transplant | — |
| Survival at 1 year | — |
Countries
United States
Outcome results
None listed