Combination Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Patients With Chronic Myelogenous Leukemia

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00002674

Enrollment

Registered

2004-08-23

Start date

1994-10-31

Completion date

2000-03-31

Last updated

2010-04-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Leukemia

Keywords

relapsing chronic myelogenous leukemia, chronic phase chronic myelogenous leukemia, accelerated phase chronic myelogenous leukemia, Philadelphia chromosome positive chronic myelogenous leukemia

Brief summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Bone marrow transplantation may be able to replace immune cells that were destroyed by chemotherapy used to kill cancer cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by G-CSF and peripheral stem cell transplantation in treating patients with chronic myelogenous leukemia.

Detailed description

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.

Interventions

BIOLOGICALfilgrastim

DRUGcytarabine

DRUGetoposide

DRUGhydroxyurea

DRUGmitoxantrone hydrochloride

PROCEDUREperipheral blood stem cell transplantation

Study design

Primary purpose

TREATMENT

Eligibility

Sex/Gender

ALL

Age

17 Years to 65 Years

Healthy volunteers

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026