Sirolimus, Cyclosporine, and Mycophenolate Mofetil in Preventing Graft-versus-Host Disease in Treating Patients With Hematologic Malignancies Undergoing Donor Peripheral Blood Stem Cell Transplant | Aplastic Anemia and MDS International Foundation

Clinical Trial: NCT01251575

Sirolimus, Cyclosporine, and Mycophenolate Mofetil in Preventing Graft-versus-Host Disease in Treating Patients With Hematologic Malignancies Undergoing Donor Peripheral Blood Stem Cell Transplant
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 sirolimus, cyclosporine and mycophenolate mofetil works in preventing graft-vs-host disease (GVHD) in patients with hematologic malignancies undergoing donor peripheral blood stem cell (PBSC) transplant. Giving chemotherapy and total-body irradiation before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving total-body irradiation together with sirolimus, cyclosporine, and mycophenolate mofetil before and after transplant may stop this from happening.

Status: 
Recruiting
Study Date: 
Wed, 12/01/2010 to Thu, 11/01/2018
Bone Marrow Disease(s): 
myelodysplastic syndromes (MDS)
Associated Drug(s): 
Intervention: 
Procedure: Allogeneic Hematopoietic Stem Cell Transplantation Undergo allogeneic peripheral blood stem cell transplant Other Names: allogeneic stem cell transplantation HSC HSCT Drug: Cyclosporine Given PO or IV Other Names: 27-400 Ciclosporin CsA Cyclosporin Cyclosporin A Neoral OL 27-400 Sandimmun Sandimmune SangCya 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 Other: Laboratory Biomarker Analysis Correlative studies Drug: Mycophenolate Mofetil Given PO Other Names: Cellcept MMF Procedure: Peripheral Blood Stem Cell Transplantation Undergo allogeneic peripheral blood stem cell transplant Other Names: PBPC transplantation Peripheral Blood Progenitor Cell Transplantation Peripheral Stem Cell Support Peripheral Stem Cell Transplantation Drug: Sirolimus Given PO Other Names: AY 22989 RAPA Rapamune RAPAMYCIN SILA 9268A WY-090217 Radiation: Total-Body Irradiation Undergo total-body irradiation Other Names: TOTAL BODY IRRADIATION Whole-Body Irradiation