Status:
COMPLETED
Imatinib Mesylate After a Donor Stem Cell Transplant in Treating Patients With Philadelphia Chromosome-Positive Leukemia
Lead Sponsor:
Fred Hutchinson Cancer Center
Conditions:
Leukemia
Eligibility:
All Genders
Phase:
PHASE1
PHASE2
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 rec...
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
January 1 2004
Trial Type :
INTERVENTIONAL
End Date :
August 1 2007
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00244829
Start Date
January 1 2004
End Date
August 1 2007
Last Update
November 30 2011
Active Locations (2)
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1
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010-3000
2
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109-1024