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CompletedNCT00244829Updated Nov 30, 2011

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

A Phase 1/2 interventional study of imatinib mesylate and adjuvant therapy in Leukemia, sponsored by Fred Hutchinson Cancer Center. Completed at 2 sites in United States. Per ClinicalTrials.gov, last updated 2011-11-30.

Sponsored by Fred Hutchinson Cancer Center · Phase 1/2, Interventional, and Treatment

Phase
Phase 1/2
Study type
Interventional
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • 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
03

In context

Leukemia

5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.

Browse Leukemia studies →

Lead sponsor

Fred Hutchinson Cancer Center is the lead sponsor of 537 studies on the registry; 79 are open to participants now.

Of its 57 completed or terminated interventional studies of FDA-regulated products, 45 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
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
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Masking
None (open label)

Interventions

  • Drugimatinib mesylate
  • Procedureadjuvant therapy
06

What researchers measure

Primary outcomes

  1. Safety at 90 days following transplant

Secondary outcomes

  1. BCR/ABL transcript load at 90 days following transplant

  2. Standard management of progressive minimal residual disease at 90 days following transplant

  3. Survival at 1 year

07

Study locations

2 sites
  • City of Hope Comprehensive Cancer Center
    Duarte, California 91010-3000, United States
  • Fred Hutchinson Cancer Research Center
    Seattle, Washington 98109-1024, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 30, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00244829
Lead sponsor
Fred Hutchinson Cancer Center
First posted
Oct 27, 2005
Start date
Jan 2004
Completion
Aug 2007
Last update
Nov 30, 2011

Study contacts

Paul Carpenter, MD
study chair · Fred Hutchinson Cancer Center
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2011. You cannot join it, but the record below documents what was studied.

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