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Granulocyte-Macrophage Colony Stimulating Factor (Rhu-GM-CSF) With Interferon-Alpha (IFN-alpha) for Chronic Myeloid Leukemia


Phase 2
18 Years
N/A
Not Enrolling
Both
Leukemia

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Trial Information

Granulocyte-Macrophage Colony Stimulating Factor (Rhu-GM-CSF) With Interferon-Alpha (IFN-alpha) for Chronic Myeloid Leukemia


OBJECTIVES: I. Estimate the rate of major cytogenetic responses to sargramostim (GM-CSF) and
interferon alfa in patients with newly diagnosed chronic phase chronic myeloid leukemia. II.
Estimate the dosing, schedule, and toxic effects of GM-CSF plus interferon alfa in these
patients.

OUTLINE: All patients are in hematologic remission on subcutaneous interferon alfa upon
entering the study. Once a complete hematologic response is achieved and the interferon alfa
dose has been stable for 14 days, patients receive subcutaneous sargramostim (GM-CSF) daily
for 6 months. Patients are followed at 3, 6, 9, and 12 months.

PROJECTED ACCRUAL: Approximately 48 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS: Cytogenetically or molecularly proven chronic phase chronic
myeloid leukemia (CML) that is Philadelphia chromosome positive OR Philadelphia chromosome
negative with evidence of the BCR-ABL rearrangement or evidence of the P120 protein On
interferon alfa therapy less than 6 months In complete hematologic response, defined as:
WBC less than 10,000/mm3 Platelet count less than 450,000/mm3 Less than 5% circulating
blasts No signs and symptoms of disease, including progressive splenomegaly

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Not specified Life
expectancy: Not specified Hematopoietic: See Disease Characteristics Hepatic: Not
specified Renal: Not specified Other: Not pregnant or nursing Fertile patients must use
effective contraception No history of intolerance to sargramostim (GM-CSF) Must be able to
perform self injection

PRIOR CONCURRENT THERAPY: Biologic therapy: Prior interferon alfa required Chemotherapy:
Prior hydroxyurea and cytarabine allowed Endocrine therapy: Not specified Radiotherapy:
Not specified Surgery: Not specified Other: No other concurrent myelosuppressive drug
therapy

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Richard J. Jones, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Sidney Kimmel Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000066625

NCT ID:

NCT00003561

Start Date:

February 1998

Completion Date:

August 2010

Related Keywords:

  • Leukemia
  • chronic phase chronic myelogenous leukemia
  • Philadelphia chromosome positive chronic myelogenous leukemia
  • Philadelphia chromosome negative chronic myelogenous leukemia
  • Leukemia
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive
  • Leukemia, Myeloid, Chronic-Phase

Name

Location
Johns Hopkins Oncology Center Baltimore, Maryland  21287