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

Leukemia Clinical Trial

Official title:

A Multicenter Pilot Study Evaluating the Safety and Efficacy of Imatinib as Post-Transplant Therapy for High- Risk Philadelphia Chromosome-Positive Leukemias

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00244829
• Other study ID #: 1867.00
• Secondary ID: FHCRC-1867.00CDR
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: October 25, 2005
• Last updated: November 28, 2011
• Start date: January 2004
• Est. completion date: August 2007

Study information

• Verified date: November 2011
• Source: Fred Hutchinson Cancer Research Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: August 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Abnormal Karyotype
• Leukemia
• Philadelphia Chromosome

Intervention

Drug:
• imatinib mesylate

Procedure:
• adjuvant therapy

Locations

Country	Name	City	State
United States	City of Hope Comprehensive Cancer Center	Duarte	California
United States	Fred Hutchinson Cancer Research Center	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Fred Hutchinson Cancer Research Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety at 90 days following transplant			Yes
Secondary	BCR/ABL transcript load at 90 days following transplant			No
Secondary	Standard management of progressive minimal residual disease at 90 days following transplant			No
Secondary	Survival at 1 year			No