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Sponsored by: |
Masonic Cancer Center, University of Minnesota |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00005984 |
RATIONALE: Giving colony-stimulating factors, such as G-CSF, and cyclophosphamide helps stem cells move from the patient's bone marrow to the blood so they can be collected and stored. Chemotherapy and radiation therapy is then given to prepare the bone marrow for the stem cell transplant. The stem cells are returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy and radiation therapy.
PURPOSE: This phase II trial is studying how well cyclophosphamide plus filgrastim followed by stem cell transplant works in treating patients with chronic phase or accelerated phase chronic myelogenous leukemia.
Condition | Intervention | Phase |
---|---|---|
Leukemia |
Drug: cyclophosphamide Drug: filgrastim Drug: recombinant interferon alfa Procedure: peripheral blood stem cell transplantation Procedure: radiation therapy |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Autologous Marrow Transplantation for Chronic Myelogenous Leukemia Using Stem Cells Obtained After In Vivo Cyclophosphamide/G-CSF Priming |
Study Start Date: | August 2000 |
OBJECTIVES:
OUTLINE: Patients receive priming therapy consisting of cyclophosphamide IV over 2 hours on day 1 and filgrastim (G-CSF) daily subcutaneously (SQ) starting on day 5 and continuing until completion of leukapheresis. Peripheral blood stem cells (PBSC) are collected between days 14-21.
Patients then receive preparative therapy for transplant consisting of cyclophosphamide IV over 2 hours on days -7 and -6 and total body irradiation twice a day on days -4 through -1. Patients receive the PBSC transplantation on day 0. Patients also receive G-CSF IV starting on day 0 and continuing until blood counts recover. Patients then receive interferon alfa SQ daily in the absence of unacceptable toxicity or disease progression.
Patients are followed at 3 weeks; then at 3, 6, 9, 12, and 18 months; and then annually for 5 years.
PROJECTED ACCRUAL: Not specified
Ages Eligible for Study: | up to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed chronic or accelerated phase chronic myelogenous leukemia (CML)
PATIENT CHARACTERISTICS:
Age:
Performance status:
Age 65-70 years:
Under 65 years:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Age 65-70 years:
Under 65 years:
Cardiovascular:
Age 65-70 years:
Pulmonary:
Age 65-70 years:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
United States, Minnesota | |
University of Minnesota Cancer Center | |
Minneapolis, Minnesota, United States, 55455 |
Study Chair: | Catherine M. Verfaillie, MD | Masonic Cancer Center, University of Minnesota |
Study ID Numbers: | CDR0000067972, UMN-MT-9611, UMN-MT-1996-11 |
Study First Received: | July 5, 2000 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00005984 |
Health Authority: | United States: Federal Government |
chronic phase chronic myelogenous leukemia accelerated phase chronic myelogenous leukemia Philadelphia chromosome positive chronic myelogenous leukemia childhood chronic myelogenous leukemia |
Philadelphia Chromosome Interferon-alpha Interferon Type I, Recombinant Chronic myelogenous leukemia Hematologic Diseases Interferons Myeloproliferative Disorders Cyclophosphamide |
Leukemia, Myeloid Leukemia, Myeloid, Chronic-Phase Leukemia Leukemia, Myeloid, Accelerated Phase Leukemia, Myelogenous, Chronic, BCR-ABL Positive Bone Marrow Diseases Interferon Alfa-2a |
Anti-Infective Agents Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Growth Substances Physiological Effects of Drugs Immunosuppressive Agents Antiviral Agents Angiogenesis Inhibitors |
Pharmacologic Actions Neoplasms Therapeutic Uses Myeloablative Agonists Antineoplastic Agents, Alkylating Angiogenesis Modulating Agents Growth Inhibitors Antirheumatic Agents Alkylating Agents |