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

Outcome

Outcome not reported

Stopped: “Study was terminated in August 2016 due to replacement by a new study.”

Drugs

EvaluationDrugModalityDoseRoute
Subject Stem Cells 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 rabbit anti-thymocyte globulin Protein / enzyme biologic — —