drugset / Trial / NCT01621477

T-Cell Replete Haploidentical Donor Hematopoietic Stem Cell Plus Natural Killer (NK) Cell Transplantation in Patients With Hematologic Malignancies Relapsed or Refractory Despite Previous Allogeneic Transplant

NCT01621477

NaSingle-groupOpen-labelTreatment

Summary

The primary aim of this protocol is to evaluate if the one-year survival is significantly improved in the group of patients who receive a T-cell replete haploidentical donor hematopoietic cell transplant (HCT) with a novel reduced intensity conditioning regimen. Study population will consist of patients (21 years or under) with hematologic malignancies that have relapsed or are refractory after prior allogeneic transplant. Toxicity will be evaluated by the rate of transplant related mortality and the rates of moderate and severe graft-versus-host disease (GvHD) at day 100. The investigators will describe event-free, and disease-free survival at one year, as well as the rates of hematopoietic recovery and donor engraftment and study comprehensively immune reconstitution following T-cell replete haploidentical transplantation.

Timeline

Start
2012-08
Primary completion
2015-12
Completion
2015-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Rexlemestrocel-L Cell therapy
Background Busulfan Small molecule
Background Clofarabine Other / unclassified
Background Cyclophosphamide Other / unclassified
Background Cytarabine Small molecule
Background Mycophenolate Mofetil Small molecule
Background Plerixafor Small molecule
Background Tacrolimus Small molecule
Background Thymoglobulin Protein / enzyme biologic