Combination Chemotherapy Followed By Umbilical Cord Blood Transplantation in Treating Patients With Hematologic Cancer or Severe Aplastic Anemia

OBJECTIVES:

- Determine the incidence and severity of acute toxicity in patients with hematologic
malignancies or severe aplastic anemia treated with a non-myeloablative conditioning
regimen followed by umbilical cord blood transplantation.

- Determine the incidence and severity of acute and chronic graft-versus-host-disease in
patients treated with this regimen.

- Determine the incidence of relapse, disease-free survival, and overall survival of
patients treated with this regimen.

- Determine the survival rate at 100 days post-transplantation in patients treated with
this regimen.

- Determine the incidence of regimen-related complications (infection, hepatic
veno-occlusive disease, and interstitial pneumonitis) in patients treated with this
regimen.

- Determine the incidence of primary and secondary graft failure in patients treated with
this regimen.

- Determine the rates and kinetics of donor-derived lymphoid, myeloid, neutrophil, RBC,
and platelet engraftment in patients treated with this regimen.

OUTLINE: Patients receive a non-myeloablative conditioning regimen comprising fludarabine IV
over 30 minutes on days -8 to -4, cyclophosphamide IV over 2 hours on days -3 to -2, and
anti-thymocyte globulin (ATG) IV over at least 4 hours on days -2 to -1. Patients unable to
tolerate ATG may receive methylprednisolone IV over 1 hour on days -3 to -1.

Patients undergo multiple unit umbilical cord blood transplantation on days 0-1. Patients
receive filgrastim (G-CSF) subcutaneously beginning on day 7 and continuing until blood
counts recover.

Patients are followed monthly for 6 months; at 9, 12, 14, 16, 18, and 24 months; and then
annually thereafter.

PROJECTED ACCRUAL: A total of 24 patients will be accrued for this study within 2 years.