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

Clinical Trial: NCT02566304

Reduced Intensity Chemotherapy and Radiation Therapy Before Donor Stem Cell Transplant in Treating Patients With Hematologic Malignancies
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