Trial Information

Use of G-CSF Stimulated HLA-Identical Allogeneic Peripheral Blood Stem Cells for Patients With High Risk Acute Myelogenous Leukemia or CML in Blast Crisis

OBJECTIVES: I. Determine the toxic effects and feasibility of using filgrastim in promoting
hematopoietic recovery and leukemia control after intensive but nonmyeloablative salvage
chemotherapy. II. Determine the engraftment kinetics and degree of chimerism achievable.

OUTLINE: The trial will have 2 patient groups. Patients not in remission are assigned to
group 1, while patients in remission are assigned to group 2. Then, groups are divided into
2 treatment arms. Patients failing fludarabine therapy receive cytarabine (Ara-C) IV over 2
hours on days -7, -6, -5, -4 and -3. Beginning 4 hours before the first dose of Ara-C,
patients receive cladribine (2-chlorodeoxyadenosine; 2-CdA) by continuous infusion for 5
days. Patients without prior fludarabine therapy receive fludarabine IV over 30 minutes
daily on days -6, -5, -4 and -3. Ara-C IV begins 4 hours after the beginning of the
fludarabine infusion and continues for 4 hours. Idarubicin IV is given on days -6, -5 and
-4. Donors receive filgrastim SC every 12 hours for 2 days prior to stem cell collection.
Cells are infused on day 0. For GVHD prophylaxis, all patients receive cyclosporine via
continuous IV infusion. Oral cyclosporine is administered once patients tolerate oral
feeding and continued for 6 months postinfusion. Then, the dose of cyclosporine is tapered
10% weekly until discontinued. Methylprednisolone begins 5 days after infusion and is
gradually tapered.

PROJECTED ACCRUAL: A maximum of 15 patients per arm are likely to be entered in 24 to 36
months.