drugset / Trial / NCT01745913

Randomized HaploCord Blood Transplantation vs. Double Umbilical Cord Blood Transplantation for Hematologic Malignancies

NCT01745913

Phase 2 Terminated 2 enrolled Weill Medical College of Cornell University
RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is compare the efficacy of haplo-cord transplant (investigational arm) with that of a more commonly used procedure in which only the cells contained in one or two umbilical cords are infused (standard arm). We hypothesize that reduced intensity conditioning and haplo-cord transplant results in fast engraftment of neutrophils and platelets, low incidences of acute and chronic graft versus host disease, low frequency of delayed opportunistic infections, reduced transfusion requirements, shortened length of hospital stay and promising long term outcomes. We also hypothesize that umbilical cord blood selection can prioritize matching and better matched donors can be identified rapidly for most subjects.

Timeline

Start
2012-10-26
Primary completion
2015-04-29
Completion
2015-04-29

Drugs

EvaluationDrugModalityDoseRoute
Background Fludarabine Small molecule 30 mg/m2 Intravenous
Background Melphalan Small molecule 70 mg/m2 Intravenous
Background Thymoglobulin Protein / enzyme biologic 1.5 mg/kg Intravenous