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


Phase 1/Phase 2
N/A
N/A
Not Enrolling
Both
Leukemia

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Trial Information

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


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.

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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety at 90 days following transplant

Safety Issue:

Yes

Principal Investigator

Paul Carpenter, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Fred Hutchinson Cancer Research Center

Authority:

United States: Federal Government

Study ID:

1867.00

NCT ID:

NCT00244829

Start Date:

January 2004

Completion Date:

August 2007

Related Keywords:

  • Leukemia
  • 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
  • Leukemia
  • Philadelphia Chromosome

Name

Location

Fred Hutchinson Cancer Research Center Seattle, Washington  98109
City of Hope Comprehensive Cancer Center Duarte, California  91010