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| ID | Type | Description | Link |
|---|---|---|---|
| FHCRC-1867.00 | |||
| CDR0000355118 | Registry Identifier | PDQ |
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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.
OBJECTIVES:
Primary
Secondary
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| imatinib mesylate | Drug | |||
| adjuvant therapy | Procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Safety at 90 days following transplant |
| Measure | Description | 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 |
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DISEASE CHARACTERISTICS:
Diagnosis of 1 of the following:
No imatinib mesylate-resistant leukemia
Planned allogeneic hematopoietic stem cell transplantation
None of the following within 4 days after the date of neutrophil engraftment*:
PATIENT CHARACTERISTICS:
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
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| Name | Affiliation | Role |
|---|---|---|
| Paul Carpenter, MD | Fred Hutchinson Cancer Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope Comprehensive Cancer Center | Duarte | California | 91010-3000 | United States | ||
| Fred Hutchinson Cancer Research Center |
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| ID | Term |
|---|---|
| D007938 | Leukemia |
| D015465 | Leukemia, Myeloid, Accelerated Phase |
| D001752 | Blast Crisis |
| D015466 | Leukemia, Myeloid, Chronic-Phase |
| D015464 | Leukemia, Myelogenous, Chronic, BCR-ABL Positive |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D000068877 | Imatinib Mesylate |
| D017024 | Chemotherapy, Adjuvant |
| ID | Term |
|---|---|
| D001549 | Benzamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D001565 | Benzoates |
| D000146 |
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| Seattle |
| Washington |
| 98109-1024 |
| United States |
| D007951 | Leukemia, Myeloid |
| D009196 | Myeloproliferative Disorders |
| D001855 | Bone Marrow Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002471 | Cell Transformation, Neoplastic |
| D063646 | Carcinogenesis |
| D009385 | Neoplastic Processes |
| Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011743 | Pyrimidines |
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D004358 | Drug Therapy |