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

• Status: Terminated
• Trial end date: 2015-12-01

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.

• Phase: Phase 2

Details

• Lead Sponsor: St. Jude Children's Research Hospital
• Collaborator: Assisi Foundation
• Treatments: Antilymphocyte Serum; Antineoplastic Agents; Busulfan; Clofarabine; Cyclophosphamide; Cytarabine; Immunosuppressive Agents; JM 3100; Mycophenolate mofetil; Mycophenolic Acid; Plerixafor; Tacrolimus; Thymoglobulin