Leukemia Clinical Trial
Official title:
Phase I/II Pilot Study of Allogeneic Peripheral Blood Stem Cell Infusion For Patients With High Risk Chronic Lymphocytic Leukemia
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer 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 and kill more
cancer cells.
PURPOSE: Phase I/II trial to study the effectiveness of combination chemotherapy plus
peripheral stem cell transplantation in treating patients with refractory chronic
lymphocytic leukemia.
OBJECTIVES: I. Determine the feasibility and toxicity of using allogeneic peripheral blood
stem cell transplantation after intensive, but non-myeloablative chemotherapy with
fludarabine/cyclophosphamide in patients with advanced chronic lymphocytic leukemia. II.
Determine the engraftment kinetics and degree of chimerism available with this strategy.
OUTLINE: This is a nonrandomized, dose-seeking study. Stem cell donors receive G-CSF for 4
days prior to and throughout stem cell harvest. Patients receive intensive chemotherapy with
fludarabine and cyclophosphamide for 3 days, with patients entered at increasing doses of
both drugs until the dose allowing engraftment is determined. Three days after intensive
chemotherapy, allogeneic stem cells are infused. Responding patients who do not experience
worse than grade 1 acute graft-vs.-host disease receive additional stem cell infusions after
60 and 120 days. Patients are followed monthly for 4 months, at 6 and 12 months, then yearly
for 5 years.
PROJECTED ACCRUAL: Up to 25 patients will be entered.
;
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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