Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Patients With Myelofibrosis

Phase 2

Completed

• Conditions: Chronic Myeloproliferative Disorders

• Registration Number: NCT00006367
• Lead Sponsor: Fred Hutchinson Cancer Center

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 2000-05
• Study First Submitted: 2000-10-04
• Study First Submitted QC: 2003-11-10
• Study First Posted: 2003-11-11
• Study Completion: 2004-01
• Status Verified: 2010-06
• Last Update Submitted: 2010-06-15
• Last Update Posted: 2010-06-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (9)

Katmai Oncology Group; 🇺🇸 Anchorage, Alaska, United States

H. Lee Moffitt Cancer Center and Research Institute; 🇺🇸 Tampa, Florida, United States

University of Illinois College of Medicine; 🇺🇸 Chicago, Illinois, United States

Mayo Clinic Cancer Center; 🇺🇸 Rochester, Minnesota, United States

Washington University Siteman Cancer Center; 🇺🇸 Saint Louis, Missouri, United States

New York Presbyterian Hospital - Cornell Campus; 🇺🇸 New York, New York, United States

Fred Hutchinson Cancer Research Center; 🇺🇸 Seattle, Washington, United States

Hopital Saint-Louis; 🇫🇷 Paris, France

Addenbrooke's NHS Trust; 🇬🇧 Cambridge, England, United Kingdom