A Multicenter Pilot Study Evaluating the Safety and Efficacy of Imatinib as Post-Transplant Therapy for High- Risk Philadelphia Chromosome-Positive Leukemias
N/A
N/A
Both
Leukemia
Trial Information
A Multicenter Pilot Study Evaluating the Safety and Efficacy of Imatinib as Post-Transplant Therapy for High- Risk Philadelphia Chromosome-Positive Leukemias
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.
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
Type of Study:
Interventional
Study Design:
Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Safety at 90 days following transplant
Safety Issue:
Yes
Principal Investigator
Paul Carpenter, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Fred Hutchinson Cancer Research Center
Authority:
United States: Federal Government
Study ID:
1867.00
NCT ID:
NCT00244829
Start Date:
January 2004
Completion Date:
August 2007
Related Keywords:
- Leukemia
- 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
- Leukemia
- Philadelphia Chromosome
Name | Location |
|---|---|
| Fred Hutchinson Cancer Research Center | Seattle, Washington 98109 |
| City of Hope Comprehensive Cancer Center | Duarte, California 91010 |
