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

Sponsor

Fred Hutchinson Cancer Center (Other)

Overall Status

Completed

CT.gov ID

NCT00244829

Collaborator

(none)

Locations

Duration (Months)

Study Details

Study Description

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 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 or Disease	Intervention/Treatment	Phase
Leukemia	Drug: imatinib mesylate Procedure: adjuvant therapy	Phase 1/Phase 2

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 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.

Study Design

Study Type:

Interventional

Masking:

None (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

Study Start Date :

Jan 1, 2004

Actual Study Completion Date :

Aug 1, 2007

Outcome Measures

Primary Outcome Measures

Safety at 90 days following transplant []

Secondary Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
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