Imatinib Mesylate After a Donor Stem Cell Transplant in Treating Patients With Philadelphia Chromosome-Positive Leukemia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2004-01-31

Study Completion Date

2007-08-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Leukemia

Keywords

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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

Study Design

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Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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imatinib mesylate

Intervention Type DRUG

adjuvant therapy

Intervention Type PROCEDURE

Eligibility Criteria

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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

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Paul Carpenter, MD

Role: STUDY_CHAIR

Fred Hutchinson Cancer Center

Locations

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City of Hope Comprehensive Cancer Center

Duarte, California, United States

Site Status

Fred Hutchinson Cancer Research Center

Seattle, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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FHCRC-1867.00

Identifier Type: -

Identifier Source: secondary_id

CDR0000355118

Identifier Type: REGISTRY