drugset / Trial / NCT01810588

Targeting the IPA and Matching for the Non-Inherited Maternal Antigen for Haplo-Cord Transplantation

NCT01810588

Phase 2 Active not recruiting 270 enrolled Weill Medical College of Cornell University
Non-randomizedSingle-groupOpen-labelTreatment

Summary

In this trial, we aim to improve the outcomes of haplo cord transplant. Haplo cord transplant is a novel and promising way to improve transplant outcomes. We hypothesize that identification of a graft that is at least 5/6 matched and inherited paternal antigen (IPA) targeted (i.e., cord blood grafts share one or more IPA antigens with the prospective recipient) is more important to the outcome of haplo cord transplant than the nucleated cell dose. The identification of such a graft for a large proportion of the subjects may necessitate accepting a lower umbilical cord graft dose. In addition to a umbilical cord blood transplant, recipients will receive stem cells from a family member ( a haplo-identical donor) . After collection and prior to infusion, these cells will be purified using a device called a CliniMACS CD34 selection device. The subject will undergo a chemotherapy conditioning regimen prior to transplantation. No experimental drugs are used in this study, and the combinations of drugs that will be used in the conditioning regimen are combinations that have been used in the past.

Timeline

Start
2012-10-16
Primary completion
2023-08-09
Completion
2028-04

Drugs

EvaluationDrugModalityDoseRoute
Background Fludarabine Small molecule 30 mg/m2 Intravenous
Background Melphalan Small molecule 70 mg/m2 Intravenous
Background Mycophenolate Mofetil Small molecule 1000 mg Oral
Background Rituximab Monoclonal antibody 375 mg/m2
Background Tacrolimus Small molecule 0.09 mg/kg Intravenous
Background Thymoglobulin Protein / enzyme biologic 1.5 mg/kg Intravenous