Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Patients With Myelofibrosis
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|ClinicalTrials.gov Identifier: NCT00006367|
Recruitment Status : Completed
First Posted : November 11, 2003
Last Update Posted : June 17, 2010
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.
PURPOSE: Phase II trial to study the effectiveness of chemotherapy followed by peripheral stem cell transplantation in treating patients who have myelofibrosis.
|Condition or disease||Intervention/treatment||Phase|
|Chronic Myeloproliferative Disorders||Biological: filgrastim Drug: busulfan Drug: cytarabine Drug: idarubicin Procedure: peripheral blood stem cell transplantation||Phase 2|
OBJECTIVES: I. Determine the ability of myeloablative chemotherapy followed by peripheral blood stem cell (PBSC) transplantation to restore effective marrow hematopoieses in patients with advanced idiopathic myelofibrosis or myelofibrosis secondary to other myeloproliferative disorders. II. Determine the ability of this regimen to palliate symptoms and prolong survival in these patients. III. Determine if there is evidence of clonal hematopoieses before PBSC mobilization, in the PBSC product, and after transplantation in these patients. IV. Correlate the properties of the peripheral blood before mobilization and the PBSC product with engraftment in these patients. V. Correlate the markers of angiogenesis with clinical parameters in these patients.
OUTLINE: Patients with evidence of leukemic progression receive cytoreduction therapy consisting of idarubicin IV on days 1-3 and cytarabine IV continuously over days 1-7 followed by filgrastim (G-CSF) subcutaneously (SC) daily until blood counts recover and leukapheresis is completed. Patients undergo leukapheresis beginning when blood counts recover and continuing until the target number of cells are collected. Patients with no evidence of leukemic progression receive filgrastim SC daily until leukapheresis is completed. Patients undergo leukapheresis beginning on day 4 and continuing until the target number of cells are collected. Patients receive myeloablative therapy consisting of oral busulfan every six hours on days -5 to -2. Patients with leukemic progression begin myeloablative therapy at least 28 days after completion of chemotherapy. Patients receive autologous peripheral blood stem cells IV on day 0. Patients are followed at 1 month, 3 months, 1 year, and then annually thereafter.
PROJECTED ACCRUAL: A total of 10-44 patients will be accrued for this study within 2 years.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||Autologous Peripheral Blood Stem Cell Mobilization and Transplantation for Myelofibrosis|
|Study Start Date :||May 2000|
|Actual Study Completion Date :||January 2004|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00006367
|United States, Alaska|
|Katmai Oncology Group|
|Anchorage, Alaska, United States, 99508-4627|
|United States, Florida|
|H. Lee Moffitt Cancer Center and Research Institute|
|Tampa, Florida, United States, 33612-9497|
|United States, Illinois|
|University of Illinois College of Medicine|
|Chicago, Illinois, United States, 60612|
|United States, Minnesota|
|Mayo Clinic Cancer Center|
|Rochester, Minnesota, United States, 55905|
|United States, Missouri|
|Washington University Siteman Cancer Center|
|Saint Louis, Missouri, United States, 63110|
|United States, New York|
|New York Presbyterian Hospital - Cornell Campus|
|New York, New York, United States, 10021|
|United States, Washington|
|Fred Hutchinson Cancer Research Center|
|Seattle, Washington, United States, 98109-1024|
|Paris, France, 75475|
|Addenbrooke's NHS Trust|
|Cambridge, England, United Kingdom, CB2 2QQ|
|Study Chair:||Jeanne E. Anderson, MD||Fred Hutchinson Cancer Research Center|