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 | Aplastic Anemia and MDS International Foundation

Clinical 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
For more details on this clinical trial, including contact information, please see this trial’s listing on clinicaltrials.gov:
Purpose: 

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.

Status: 
Recruiting
Study Date: 
Wed, 08/01/2012 to Wed, 08/01/2018
Bone Marrow Disease(s): 
myelodysplastic syndromes (MDS)
Associated Drug(s): 
Intervention: 
Drug: clofarabine Given on Day -9 and Day -8 (Day 0 is first stem cell infusion). Drug class: antineoplastic agent Other Names: Cl-F-Ara-A CAFdA Clofarex Clolar(TM) Drug: cytarabine Given on Day -9 and Day -8 (Day 0 is first stem cell infusion). Drug class: antineoplastic agent Other Name: Ara-C Drug: busulfan Given on Day -7 and Day -6 (Day 0 is first stem cell infusion). Drug class: antineoplastic agent Other Names: Myleran(R) Busulfex Drug: Plerixafor Given on Day -7 and Day -6 (Day 0 is first stem cell infusion). Drug class: Hematopoietic Stem Cell Mobilizer Other Names: AMD3100 Mozobil(R) Drug: cyclophosphamide Given on Day -5 and Day +4 (Day 0 is first stem cell infusion). Drug class: antineoplastic agent; immunosuppressive agent. Other Name: Cytoxan Drug: antithymocyte globulin (rabbit) Given on Day -4, Day -3, Day -2, and Day -1 (Day 0 is first stem cell infusion). Drug class: immunosuppressive agent. Other Names: Rabbit ATG Rabbit Thymoglobulin(R) Biological: stem cells Patients undergo T cell replete Hematopoietic stem cell infusion on Day 0 and Day +1. Patients undergo natural killer (NK) cell transplantation on day +6 (Day 0 is first stem cell infusion). Other Name: HSC infusion Drug: Tacrolimus Given on Day +11 (Day 0 is first stem cell infusion). Drug class: immunosuppressive agent. Other Names: FK506 Prograf(R) Protonic(R) Drug: mycophenolate mofetil Given on Day +11 (Day 0 is first stem cell infusion). Drug class: immunosuppressive agent. Other Names: MMF CellCept(R)