Reduced Intensity Chemotherapy and Radiation Therapy Before Donor Stem Cell Transplant in Treating Patients With Hematologic Malignancies | Aplastic Anemia & MDS International Foundation
Reduced Intensity Chemotherapy and Radiation Therapy Before Donor Stem Cell Transplant in Treating Patients With Hematologic Malignancies

Clinical Trial: NCT02566304

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

PRIMARY OBJECTIVES:

I. To demonstrate efficacy of this approach over the historical 2 step reduced intensity conditioning (RIC) approaches in the "vulnerable" population defined as: patients with hematopoietic cell transplant (HCT)-co-morbidity index (CI)/age scores >= 2, but no more than a score of 5 as based on the Sorror et al. data.

SECONDARY OBJECTIVES:

I. To compare the non-relapse mortality (NRM) and relapse related mortality (RRM) rates at 1 year for patients treated on this study to the that of patients undergoing haploidentical RIC hematopoietic stem cell transplantation (HSCT) as reported in the literature and as observed in the 2 step RIC trials.

II. To determine the incidence and severity of graft-versus-host disease (GVHD) in patients undergoing treated on the Thomas Jefferson University (TJU) RIC 2 step approach.

III. To evaluate engraftment rates and lymphoid reconstitution in patients treated on the TJU RIC 2 step approach.

OUTLINE:

RIC: Patients receive fludarabine phosphate intravenously (IV) over 60 minutes on days -10 to -8 and cyclophosphamide IV over 2 hours on days -3 and -2. Patients also undergo total body irradiation (TBI) followed by a donor lymphocyte infusion (DLI) on day -6.

TRANSPLANT: Patients undergo cluster of differentiation (CD)34+ peripheral blood stem cell transplant on day 0.

GVHD PROPHYLAXIS: Patients receive tacrolimus orally (PO) beginning day -1 with a taper initiated on day 42 and mycophenolate mofetil IV twice daily (BID) on days -1 to 28 in the absence of GVHD.

After completion of study treatment, patients are followed up for 1 year.

Status: 
Recruiting
Study Date: 
Wed, 09/30/2015 to Tue, 09/01/2020
Bone Marrow Disease(s): 
aplastic anemia
Intervention: 
Drug: Fludarabine Given IV Other Names: Fludarabine phosphate Fludara Radiation: Total-Body Irradiation Undergo TBI Biological: T Cell-Depleted Donor Lymphocyte Infusion Undergo DLI Drug: Cyclophosphamide Given IV Other Names: Endoxan Cytoxan Neosar Procytox Revimmune Cycloblastin Cytophosphane CP Procedure: Peripheral Blood Stem Cell Transplantation Undergo PBSC transplant Procedure: Allogeneic Hematopoietic Stem Cell Transplantation Undergo PBSC transplant Drug: Tacrolimus Given PO Other Names: FK-506 Fujimycin Prograf Advograf Protopic Drug: Mycophenolate mofetil Given IV Other Names: Mycophenolic acid MMF CellCept Myfortic