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CYTOREDUCTIVE CHEMOTHERAPY WITH MITOXANTRONE, CYTOSINE ARABINOSIDE AND ETOPOSIDE FOLLOWED BY RECOMBINANT HUMAN G-CSF FOR MOBILIZATION OF PERIPHERAL BLOOD STEM CELLS IN PATIENTS WITH CHRONIC MYELOID LEUKEMIA


Phase 2
17 Years
65 Years
Not Enrolling
Both
Leukemia

Thank you

Trial Information

CYTOREDUCTIVE CHEMOTHERAPY WITH MITOXANTRONE, CYTOSINE ARABINOSIDE AND ETOPOSIDE FOLLOWED BY RECOMBINANT HUMAN G-CSF FOR MOBILIZATION OF PERIPHERAL BLOOD STEM CELLS IN PATIENTS WITH CHRONIC MYELOID LEUKEMIA


OBJECTIVES: I. Evaluate the efficacy of MCE (mitoxantrone/cytarabine/etoposide) followed by
granulocyte colony-stimulating factor to mobilize peripheral blood stem cells (PBSC) in
patients with chronic myeloid leukemia (CML). II. Evaluate the toxicity of this regimen.
III. Evaluate the cytoreductive effects of this regimen in CML as determined by the ability
to mobilize Philadelphia chromosome-negative PBSC. IV. Assess the time of peak CD34+ and
CD34+/CD38- cell concentrations in the peripheral blood of patients treated with this
regimen.

OUTLINE: The following acronyms are used: ARA-C Cytarabine, NSC-63878 DHAD Mitoxantrone,
NSC-301739 G-CSF Granulocyte Colony-Stimulating Factor (source not specified) HU
Hydroxyurea, NSC-32065 MCE DHAD/ARA-C/VP-16 VP-16 Etoposide, NSC-141540 Single-Agent
Cytoreduction followed by 3-Drug Combination Chemotherapy/Stem Cell Mobilization. HU;
followed by MCE; G-CSF.

PROJECTED ACCRUAL: 30 patients will be entered over 3 years.

Inclusion Criteria


DISEASE CHARACTERISTICS: Philadelphia chromosome-positive chronic myeloid leukemia (CML)
in chronic or accelerated phase Ineligible for allograft protocols or no available
HLA-matched sibling marrow donor No patients under age 55 who have consented to unrelated
donor search unless: Search unsuccessful for 6 months and unlikely a donor will be found
Transplant from an unrelated donor declined No history of CML blast crisis No grade III/IV
myelofibrosis

PATIENT CHARACTERISTICS: Age: Over 17 to under 66 Performance status: Not specified Life
expectancy: No limitations from disease other than leukemia Other: No hepatic, renal,
pulmonary, or cardiac dysfunction that would preclude transplant preparative regimen No
HIV antibody No active infection

PRIOR CONCURRENT THERAPY: At least 1 month since interferon

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Leona A. Holmberg, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Fred Hutchinson Cancer Research Center

Authority:

United States: Federal Government

Study ID:

928.00

NCT ID:

NCT00002674

Start Date:

October 1994

Completion Date:

March 2000

Related Keywords:

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

Name

Location
Fred Hutchinson Cancer Research Center Seattle, Washington  98109