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Granulocyte-Macrophage Colony Stimulating Factor (Rhu-GM-CSF) and Autologous Bone Marrow Transplantation for Chronic Myeloid Leukemia


Phase 2
12 Years
70 Years
Not Enrolling
Both
Leukemia

Thank you

Trial Information

Granulocyte-Macrophage Colony Stimulating Factor (Rhu-GM-CSF) and Autologous Bone Marrow Transplantation for Chronic Myeloid Leukemia


OBJECTIVES: I. Determine the one year event-free survival in patients with chronic phase
chronic myeloid leukemia receiving sargramostim (GM-CSF)-treated autologous bone marrow
transplantation followed by GM-CSF and interferon alfa. II. Determine the toxicity of this
regimen in these patients.

OUTLINE: Patients undergo harvesting of autologous bone marrow. A portion of the cells are
treated ex vivo with sargramostim (GM-CSF) for 3 days. Patients then receive myeloablative
chemotherapy with busulfan and cyclophosphamide on days -9 to -2 according to the
preparative regimen protocol. Patients undergo sargramostim (GM-CSF)-treated autologous bone
marrow transplantation on day 0. Patients receive GM-CSF subcutaneously daily on days 5-180,
and interferon alfa daily on days 90-180. Patients are followed monthly for 1 year, every 6
months for 2 years, and then annually for 3 years.

PROJECTED ACCRUAL: A total of 9-19 patients will be accrued for this study within 2-3 years.

Inclusion Criteria


DISEASE CHARACTERISTICS: Diagnosis of chronic phase chronic myeloid leukemia (CML) by
cytogenetic and/or molecular analyses No more than 10% blasts on blood and bone marrow
morphology Philadelphia (Ph) chromosome positive Ph chromosome-negative CML allowed if
evidence of the BCR-ABL rearrangement by molecular or FISH analyses or evidence of the
P120 protein Duration of CML less than 3 years, unless cytogenetic remission to interferon
has been achieved Failed to obtain and maintain a complete cytogenetic remission on a
prior trial of interferon therapy Absence of detectable PH-negative cells in bone marrow
or blood after 6 months of therapy Lack of a progressive increase in Ph-negative cells
between 6 and 12 months of therapy Less than 50% Ph-negative cells after 12 months of
therapy Absence of complete cytogenetic remission after 24 months of therapy Inability to
tolerate prior interferon therapy No accelerated phase or blast crisis CML, chronic
myelomonocytic leukemia, or juvenile CML Concurrent enrollment on the busulfan and
cyclophosphamide preparative regimen protocol

PATIENT CHARACTERISTICS: Age: 12 to 70 Performance status: Not specified Life expectancy:
Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified
Other: No history of intolerance to sargramostim (GM-CSF)

PRIOR CONCURRENT THERAPY: See Disease Characteristics

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

B. Douglas Smith, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Sidney Kimmel Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000068460, J9833

NCT ID:

NCT00011934

Start Date:

May 1998

Completion Date:

Related Keywords:

  • Leukemia
  • relapsing chronic myelogenous 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

Name

Location

Johns Hopkins Oncology CenterBaltimore, Maryland  21287