Reduced-Intensity Preparative Regimen for Allogeneic Stem Cell Transplantation in Patients With Severe Aplastic Anemia

• Status: Withdrawn
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the effectiveness of allogeneic transplant after a reduced-intensity preparative regimen for patient, to evaluate survival, and to evaluate the side effects of this treatment. The patient will be in the study for two years for treatment and active monitoring. After treatment and active monitoring are over, the patient's medical condition will be followed indefinitely.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: City of Hope Medical Center
• Treatments: Cyclophosphamide; Fludarabine; Fludarabine phosphate; Thymoglobulin

Criteria

Inclusion Criteria:

• 21 years old or younger

• Male or female recipients must have histopathologically confirmed diagnosis of severe aplastic anemia. Diagnostic Criteria for Server Aplastic Anemia will be based on the definitions set forth by the international Aplastic Anemia Study Group

• At least two of the following:

Absolute neutrophil count <0.5 x 109/L Platelet count <20 x 109 /L Anemia with corrected reticulocyte count <1%

AND

• Bone marrow cellularity <25%, or bone marrow cellularity <50% with fewer than 30% hematopoietic cell

• Availability of an HLA identical sibling

Exclusion Criteria:

• Active and uncontrolled infection

• HIV-1 infection

• Pregnancy or breastfeeding.

• DLCO <40% predicted

• Left Ventricular Ejection Fraction < 40%

• Performance scale Karnofsky <=40% or Lansky<=40% for patients <16 years old