drugset / Trial / NCT00578266

Allogeneic Stem Cell Transplantation for Patients With Severe Aplastic Anemia

NCT00578266

Phase 1 Completed 8 enrolled Mayo Clinic
NaSingle-groupOpen-labelTreatment

Summary

For patients with severe aplastic anemia (SAA) who have failed to respond to immunosuppressive therapy and lack an HLA identical family member, our objectives are to make an initial assessment of the safety and efficacy of allogenic stem cell transplantation from either a matched unrelated donor or a mismatched reacted donor using the conditioning regimen of Cytoxan, reduced total body irradiation (TBI) and Campath IH. The principle measures of safety and efficacy will be : 1. Patient survival probability at 100 days, 1 year and 2 years. 2. Incidence of graft versus host disease (GVHD), as well as incidence of acute GVHD and chronic GVHD within 6 months and 2 years. 3. Engraftment at 6 months, 1 year and 2 years

Timeline

Start
2007-02
Primary completion
2016-08-16
Completion
2016-08-16

Drugs

EvaluationDrugModalityDoseRoute
Subject Campath IH Unknown
Subject Cyclophosphamide Other / unclassified 50 mg/kg
Background 2-MERCAPTOETHANESULFONIC ACID Small molecule
Background Tacrolimus Small molecule

Indications