Imatinib Mesylate After a Donor Stem Cell Transplant in Treating Patients With Philadelphia Chromosome-Positive Leukemia
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Leukemia |
Drug: imatinib mesylate Procedure: adjuvant therapy |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Multicenter Pilot Study Evaluating the Safety and Efficacy of Imatinib as Post-Transplant Therapy for High- Risk Philadelphia Chromosome-Positive Leukemias |
- Safety at 90 days following transplant [ Designated as safety issue: Yes ]
- BCR/ABL transcript load at 90 days following transplant [ Designated as safety issue: No ]
- Standard management of progressive minimal residual disease at 90 days following transplant [ Designated as safety issue: No ]
- Survival at 1 year [ Designated as safety issue: No ]
| Study Start Date: | January 2004 |
| Study Completion Date: | August 2007 |
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.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, California | |
| City of Hope Comprehensive Cancer Center | |
| Duarte, California, United States, 91010-3000 | |
| United States, Washington | |
| Fred Hutchinson Cancer Research Center | |
| Seattle, Washington, United States, 98109-1024 | |
| Study Chair: | Paul Carpenter, MD | Fred Hutchinson Cancer Research Center |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00244829 History of Changes |
| Other Study ID Numbers: | 1867.00, FHCRC-1867.00, CDR0000355118 |
| Study First Received: | October 25, 2005 |
| Last Updated: | November 28, 2011 |
| Health Authority: | United States: Federal Government |
Keywords provided by Fred Hutchinson Cancer Research Center:
|
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 |
Additional relevant MeSH terms:
|
Leukemia Philadelphia Chromosome Neoplasms by Histologic Type Neoplasms Translocation, Genetic Chromosome Aberrations Pathologic Processes |
Imatinib Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 23, 2013