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

Primary Purpose

Leukemia

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
imatinib mesylate
adjuvant therapy
Sponsored by
Fred Hutchinson Cancer Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Leukemia focused on measuring 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

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • City of Hope Comprehensive Cancer Center
  • Fred Hutchinson Cancer Research Center

Outcomes

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

Full Information

First Posted
October 25, 2005
Last Updated
November 28, 2011
Sponsor
Fred Hutchinson Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT00244829
Brief Title
Imatinib Mesylate After a Donor Stem Cell Transplant in Treating Patients With Philadelphia Chromosome-Positive Leukemia
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 Type
Interventional

2. Study Status

Record Verification Date
November 2011
Overall Recruitment Status
Completed
Study Start Date
January 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Fred Hutchinson Cancer Center

4. Oversight

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia
Keywords
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Masking
None (Open Label)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
imatinib mesylate
Intervention Type
Procedure
Intervention Name(s)
adjuvant therapy
Primary Outcome Measure Information:
Title
Safety at 90 days following transplant
Secondary Outcome Measure Information:
Title
BCR/ABL transcript load at 90 days following transplant
Title
Standard management of progressive minimal residual disease at 90 days following transplant
Title
Survival at 1 year

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Carpenter, MD
Organizational Affiliation
Fred Hutchinson Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
City of Hope Comprehensive Cancer Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010-3000
Country
United States
Facility Name
Fred Hutchinson Cancer Research Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109-1024
Country
United States

12. IPD Sharing Statement

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

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