Aplastic Anemia Clinical Trial
Official title:
A Dose Finding Study of Total Body Irradiation for Conditioning Patients With Severe Aplastic Anemia Transplanted With Umbilical Cord Blood
RATIONALE: Giving chemotherapy and total-body irradiation before a donor umbilical cord
blood stem cell transplant helps stop the growth of abnormal cells. It also helps stop the
patient's immune system from rejecting the donor's stem cells. When the healthy stem cells
from a donor are infused into the patient they may help the patient's bone marrow make stem
cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells
from a donor can make an immune response against the body's normal cells. Giving
cyclosporine and mycophenolate mofetil before and after transplant may stop this from
happening.
PURPOSE: This phase I trial is studying the side effects and best dose of total-body
irradiation when given together with cyclophosphamide and antithymocyte globulin in treating
patients with severe aplastic anemia undergoing umbilical cord blood transplant.
OBJECTIVES:
I. The objective of this study is to determine the lowest dose of total body irradiation
combined with cyclophosphamide and antithymocyte globulin that will achieve sustained
engraftment in patients with severe aplastic anemia transplanted with unrelated umbilical
cord blood.
OUTLINE: This is a dose-escalation study of total-body irradiation (TBI).
MYELOABLATIVE CONDITIONING REGIMEN: Patients receive cyclophosphamide IV on days -7 to -4,
-6 to -3, or -5 to -2 and antithymocyte globulin IV on days -6 to -4, -5 to -3, or -4 to -2.
TBI: Patients undergo TBI twice daily on days -3, -2, and/or -1.
UMBILICAL CORD BLOOD TRANSPLANTATION (UCBT): Patients undergo UCBT on day 0. Patients
receive filgrastim (G-CSF) IV or subcutaneously beginning on day 1 and continuing until
blood counts recover.
GRAFT-VS-HOST DISEASE (GVHD) PROPHYLAXIS: Patients receive cyclosporine IV or orally (twice
daily for patients >= 6 years of age or 3 times daily for patients < 6 years of age) on days
-1 to +180 and mycophenolate mofetil IV or orally (twice daily for patients >= 50 kg or 3
times daily for patients < 50 kg) beginning 4 hours after UCBT and continuing until
approximately day +0.
After completion of study therapy, patients are followed periodically.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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