Alemtuzumab Plus Peripheral Stem Cell Transplantation in Treating 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.
Procedure: peripheral blood stem cell transplantation
Radiation: radiation therapy
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study of Campath-1H (NSC #950010) and Peripheral Blood Stem Cell Transplant for Patients With Chronic Lymphocytic Leukemia|
|Study Start Date:||February 2001|
|Primary Completion Date:||December 2004 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00006390
|United States, Illinois|
|Veterans Affairs Medical Center - Lakeside Chicago|
|Chicago, Illinois, United States, 60611-4494|
|Robert H. Lurie Comprehensive Cancer Center at Northwestern University|
|Chicago, Illinois, United States, 60611|
|United States, Maryland|
|Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins|
|Baltimore, Maryland, United States, 21231|
|United States, Massachusetts|
|Cancer Center at Tufts - New England Medical Center|
|Boston, Massachusetts, United States, 02111|
|Beth Israel Deaconess Medical Center|
|Boston, Massachusetts, United States, 02215|
|United States, Minnesota|
|CCOP - Metro-Minnesota|
|Saint Louis Park, Minnesota, United States, 55416|
|United States, New Jersey|
|CCOP - Northern New Jersey|
|Hackensack, New Jersey, United States, 07601|
|United States, Pennsylvania|
|CCOP - Geisinger Clinic and Medical Center|
|Danville, Pennsylvania, United States, 17822-2001|
|Penn State Cancer Institute at Milton S. Hershey Medical Center|
|Hershey, Pennsylvania, United States, 17033-0850|
|Abramson Cancer Center at the University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104|
|Fox Chase Cancer Center|
|Philadelphia, Pennsylvania, United States, 19111-2497|
|Hillman Cancer Center at University of Pittsburgh Cancer Institute|
|Pittsburgh, Pennsylvania, United States, 15236|
|United States, Wisconsin|
|University of Wisconsin Comprehensive Cancer Center|
|Madison, Wisconsin, United States, 53792-0001|
|CCOP - Marshfield Clinic Research Foundation|
|Marshfield, Wisconsin, United States, 54449|
|Study Chair:||Ian W. Flinn, MD, PhD||Sidney Kimmel Comprehensive Cancer Center|