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Completed

NCT Number: NCT00002674

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

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.

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Key information

Conditions

Leukemia Bone Marrow Diseases Chronic Disease Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases Leukemia, Myelogenous, Chronic, BCR-ABL Positive Leukemia, Myeloid Leukemia, Myeloid, Accelerated Phase Leukemia, Myeloid, Chronic-Phase Myeloproliferative Disorders Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

17 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

filgrastim

Biological

Cytarabine

Drug

etoposide

Drug

Hydroxyurea

Drug

mitoxantrone hydrochloride

Drug

peripheral blood stem cell transplantation

Procedure

Sponsors and collaborators

Lead sponsor

Fred Hutchinson Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
1994
Primary completion
2000
Study completion
2000
First posted
Aug 23, 2004
Registry last updated
Apr 2, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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