drugset / Trial / NCT03955601

A Novel TBI Free Conditioning Protocol for Haploidentical Transplant in Acquired Aplastic Anemia:

NCT03955601

NaSingle-groupOpen-labelTreatment

Summary

Severe and very severe aplastic anemia are life threatening disorders for which allogeneic stem cell transplant is only curative treatment. However, matched sibling donor (MSD) is available in only 25-35% cases. Pakistan has a population of around 203 million but there is no donor registry available so there is no option available for matched unrelated donor (MUD) transplants . Haploidentical transplant represents only curative option for patients lacking MSD. Protocols involving post transplant cyclophosphamide require Total body irradiation (TBI) and utilize peripheral blood stem cell(PBSC) as graft source. TBI is not available in most of transplant centres across Pakistan due to lack of availability , cost and lack of expertise. The investigators have conceived a novel TBI free conditioning regimen to be used for haplo-identical Hemtopoeitic stem cell transplant in acquired aplastic anemia patients

Timeline

Start
2018-07-12
Primary completion
2020-12-30
Completion
2021-06-30

Drugs

EvaluationDrugModalityDoseRoute
Background ANTILYMPHOCYTE IMMUNOGLOBULIN (HORSE) Protein / enzyme biologic 5 mg/kg
Background Busulfan Small molecule 3.2 mg/kg Intravenous
Background Cyclophosphamide Other / unclassified 14.5 mg/kg Intravenous
Background Cyclophosphamide Other / unclassified 30 mg/kg Intravenous
Background Cyclophosphamide Other / unclassified 50 mg/kg Intravenous