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Phase II Study of Campath-1H (NSC #950010) and Peripheral Blood Stem Cell Transplant for Patients With Chronic Lymphocytic Leukemia
RATIONALE: Monoclonal antibodies such as alemtuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy or radiation therapy. Combining monoclonal antibody therapy, chemotherapy, radiation therapy, and peripheral stem cell transplantation may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of alemtuzumab plus peripheral stem cell transplantation in treating patients who have chronic lymphocytic leukemia.
OBJECTIVES: * Determine the ability of in vivo purging with alemtuzumab (monoclonal antibody CD52; Campath-1H) to produce a stem cell graft without detectable leukemia cells in patients with chronic lymphocytic leukemia. * Determine the ability to successfully mobilize stem cells after in vivo purging with monoclonal antibody CD52 in these patients. * Determine the toxicity of this treatment regimen in these patients. * Determine the response to this treatment regimen in these patients at 6 months after peripheral blood stem cell transplantation. OUTLINE: This is a multicenter study. Patients receive induction therapy comprising alemtuzumab (monoclonal antibody CD52; Campath-1H) IV over 2 hours three times a week for 4 weeks. Beginning no more than 2 weeks after induction therapy, patients receive mobilization chemotherapy comprising cyclophosphamide IV over 1-2 hours on day 1 and filgrastim (G-CSF) subcutaneously (SC) starting on day 2 and continuing until the last day of apheresis. Patients undergo peripheral blood stem cell apheresis on days 10-14. Beginning 2-4 weeks after apheresis, patients receive a preparative regimen comprising cyclophosphamide IV over 2 hours on days -5 and -4 and fractionated total body irradiation twice a day over 6-10 hours on days -3 to -1. Patients undergo peripheral blood stem cell transplantation on day 0. Patients receive G-CSF SC beginning on day 1 and continuing until blood counts recover. Patients are followed at 60 days, 1 year, and then annually thereafter until disease progression. PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
Age
18 - 65 years
Sex
ALL
Healthy Volunteers
No
Veterans Affairs Medical Center - Lakeside Chicago
Chicago, Illinois, United States
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States
Cancer Center at Tufts - New England Medical Center
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, United States
CCOP - Northern New Jersey
Hackensack, New Jersey, United States
CCOP - Geisinger Clinic and Medical Center
Danville, Pennsylvania, United States
Penn State Cancer Institute at Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
Abramson Cancer Center at the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Start Date
July 5, 2001
Primary Completion Date
December 1, 2004
Last Updated
June 22, 2023
alemtuzumab
BIOLOGICAL
filgrastim
BIOLOGICAL
cyclophosphamide
DRUG
peripheral blood stem cell transplantation
PROCEDURE
radiation therapy
RADIATION
Lead Sponsor
Eastern Cooperative Oncology Group
Collaborators
NCT07388563
NCT00106925
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