Donor Peripheral Blood Stem Cell Transplant in Treating Patients With Hematologic Malignancies | Aplastic Anemia and MDS International Foundation

Clinical Trial: NCT01028716

Donor Peripheral Blood 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: 

This phase II trial studies how well donor peripheral blood stem cell (PBSC) transplant works in treating patients with hematologic malignancies. Cyclophosphamide when added to tacrolimus and mycophenolate mofetil is safe and effective in preventing severe graft-versus-host disease (GVHD) in most patients with hematologic malignancies undergoing transplantation of bone marrow from half-matched (haploidentical) donors. This approach has extended the transplant option to patients who do not have matched related or unrelated donors, especially for patients from ethnic minority groups. The graft contains cells of the donor's immune system which potentially can recognize and destroy the patient's cancer cells (graft-versus-tumor effect). Rejection of the donor's cells by the patient's own immune system is prevented by giving low doses of chemotherapy (fludarabine phosphate and cyclophosphamide) and total-body irradiation before transplant. Patients can experience low blood cell counts after transplant. Using stem cells and immune cells collected from the donor's circulating blood may result in quicker recovery of blood counts and may be more effective in treating the patient's disease than using bone marrow.

Status: 
Recruiting
Study Date: 
Mon, 02/01/2010 to Wed, 02/01/2017
Bone Marrow Disease(s): 
myelodysplastic syndromes (MDS)
Intervention: 
Drug: Cyclophosphamide Given IV Other Names: (-)-Cyclophosphamide 2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate Carloxan Ciclofosfamida Ciclofosfamide Cicloxal Clafen Claphene CP monohydrate CTX CYCLO-cell Cycloblastin Cycloblastine Cyclophospham Cyclophosphamid monohydrate Cyclophosphamidum Cyclophosphan Cyclophosphane Cyclophosphanum Cyclostin Cyclostine Cytophosphan Cytophosphane Cytoxan Fosfaseron Genoxal Genuxal Ledoxina Mitoxan Neosar Revimmune Syklofosfamid WR- 138719 Biological: Filgrastim Given IV or SC Other Names: Filgrastim XM02 G-CSF Neupogen r-metHuG-CSF Recombinant Methionyl Human Granulocyte Colony Stimulating Factor rG-CSF Tbo-filgrastim Tevagrastim Drug: Fludarabine Phosphate Given IV Other Names: 2-F-ara-AMP 9H-Purin-6-amine, 2-fluoro-9-(5-O-phosphono-.beta.-D-arabinofuranosyl)- Beneflur Fludara Oforta SH T 586 Procedure: Laboratory Biomarker Analysis Correlative studies Drug: Mycophenolate Mofetil Given PO Other Names: Cellcept MMF Procedure: Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation Undergo PBSC Other Names: Non-myeloablative allogeneic transplant Nonmyeloablative Stem Cell Transplantation NST Procedure: Peripheral Blood Stem Cell Transplantation Undergo PBSC Other Names: PBPC transplantation Peripheral Blood Progenitor Cell Transplantation Peripheral Stem Cell Support Peripheral Stem Cell Transplantation Drug: Tacrolimus Given IV or PO Other Names: FK 506 Fujimycin Prograf Protopic Radiation: Total-Body Irradiation Undergo total-body irradiation Other Names: TOTAL BODY IRRADIATION Whole-Body Irradiation