A PILOT STUDY OF TOTAL BODY IRRADIATION AND CYCLOPHOSPHAMIDE FOLLOWED BY AUTOLOGOUS TRANSPLANTATION WITH CD34 SELECTED PERIPHERAL BLOOD STEM CELLS IN PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA
OBJECTIVES: I. Evaluate engraftment after autografting with CD34 selected peripheral blood
stem cells (PBSC) in patients with chronic lymphocytic leukemia (CLL). II. Evaluate the
efficacy of CD34 selection for purging CLL from PBSC collection. III. Determine the
effectiveness of mobilization chemotherapy with cyclophosphamide, etoposide, and
dexamethasone plus filgrastim (granulocyte colony-stimulating factor) to mobilize PBSC in
these patients. IV. Describe toxicity and disease response to a conditioning regimen of
total body irradiation and cyclophosphamide in these patients.
OUTLINE: There are 3 phases to the treatment plan: Cytoreductive chemotherapy can be given
by conventional chemotherapy. Patients are treated until at least a good partial remission.
Patients will have CD34 selected peripheral blood stem cells (PBSC) stored after treatment
with mobilization chemotherapy followed by filgrastim (granulocyte colony-stimulating
factor; G-CSF). Cyclosphosphamide (CTX) IV is given over 1 hour. Etoposide (VP-16) is given
over 1-2 hours on day 2. Dexamethasone is given 4 times a day on days 1-3. G-CSF is given
subcutaneously daily beginning 2 days after chemotherapy and continuing until PBSC
collection is completed. At least 4 weeks should ensue after mobilization chemotherapy
before proceeding with the transplant. Patients are treated with TBI on days -6, -5, and -4
and CTX on days -3 and -2. PBSC are infused on day 0.
PROJECTED ACCRUAL: A total of 15 patients will be entered in this study.
Primary Purpose: Treatment
David G. Maloney, MD, PhD
Fred Hutchinson Cancer Research Center
United States: Federal Government
|Fred Hutchinson Cancer Research Center||Seattle, Washington 98109|