drugset / Trial / NCT01350245

Bone Marrow Transplantation of Patients in Remission Using Partially Matched Relative Donor

NCT01350245 ↗

NaSingle-groupOpen-labelTreatment

Summary

The primary hypothesis of this research study is that patients in remission undergoing myeloablative haploidentical hematopoietic stem cell transplantation (HSCT) on the Thomas Jefferson University (TJU) 2 Step treatment regimen will have a disease-free survival (DFS) rate at 1 year that is the same or better than the historical DFS of patients with similar diagnoses and ages undergoing matched sibling HSCT. Based on a review of the literature a DFS rate of 50% or better at 1 year would meet the criterion for an effective alternative therapy. A DFS rate of 75% or better would imply superior efficacy of the TJU 2 Step approach over T-replete matched sibling HSCT.

Timeline

Start
2010-07
Primary completion
2013-05
Completion
2014-05

Drugs

EvaluationDrugModalityDoseRoute
Background Cyclophosphamide Other / unclassified 60 mg/kg —
Background Mycophenolate Mofetil Small molecule — —
Background Tacrolimus Small molecule — —