Phase II Study of Campath-1H (NSC #950010) and Peripheral Blood Stem Cell Transplant for Patients With Chronic Lymphocytic Leukemia
- 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
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
Masking: Open Label, Primary Purpose: Treatment
Ian W. Flinn, MD, PhD
Sidney Kimmel Comprehensive Cancer Center
United States: Food and Drug Administration
|Fox Chase Cancer Center||Philadelphia, Pennsylvania 19111|
|Beth Israel Deaconess Medical Center||Boston, Massachusetts 02215|
|CCOP - Metro-Minnesota||Saint Louis Park, Minnesota 55416|
|CCOP - Northern New Jersey||Hackensack, New Jersey 07601|
|Penn State Cancer Institute at Milton S. Hershey Medical Center||Hershey, Pennsylvania 17033-0850|
|University of Wisconsin Comprehensive Cancer Center||Madison, Wisconsin 53792|
|Cancer Center at Tufts - New England Medical Center||Boston, Massachusetts 02111|
|CCOP - Geisinger Clinic and Medical Center||Danville, Pennsylvania 17822-2001|
|Abramson Cancer Center at the University of Pennsylvania||Philadelphia, Pennsylvania 19104|
|Veterans Affairs Medical Center - Lakeside Chicago||Chicago, Illinois 60611|
|Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins||Baltimore, Maryland 21231-2410|
|Hillman Cancer Center at University of Pittsburgh Cancer Institute||Pittsburgh, Pennsylvania 15236|
|CCOP - Marshfield Clinic Research Foundation||Marshfield, Wisconsin 54449|
|Robert H. Lurie Comprehensive Cancer Center at Northwestern University||Chicago, Illinois 60611|