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Clinical Trial 18766
Interventions:Cellcept (Mycophenolate Mofetil); Mycophenolate Mofetil; Rapamune (Sirolimus); Rapamycin (Sirolimus); Sirolimus; busulfan; cyclophosphamide; cytoxan (cyclophosphamide); fludarabine (Fludarabine phosphate)
Study Type: Prevention
Phase of Study: Phase II
- Joseph Pidala
A Calcineurin Inhibitor-Free GVHD Prevention Regimen After Related Haploidentical Peripheral Blood Stem Cell Transplantation
The purpose of this study is to find out if a combination of drugs (these are called: cyclophosphamide, sirolimus, and mycophenolate mofetil) will protect participants better against graft vs. host disease (GVHD) after receiving a hematopoietic cell transplant from a related partially matched (haploidentical) donor. As part of the treatment for their blood cancer, participants need a hematopoietic cell transplantation (HCT) to improve their chances of cure. In any HCT, after the stem cell infusion is given, a combination of drugs is needed to prevent GVHD and facilitate acceptance of the graft.
Primary objective is to estimate the cumulative incidence of grade II-IV acute GVHD by day 100 after related haploidentical peripheral blood stem cell transplantation using the GVHD prophylaxis regimen PTCy, sirolimus and mycophenolate mofetil. Secundary objectives are: - To determine the cumulative incidence of chronic GVHD by 1 year. - To examine additional transplantation outcomes including malignancy relapse, overall survival, progression-free survival, non-relapse mortality, and engraftment and immune reconstitution. - To examine peripheral blood markers of immune tolerance development. - To evaluate the impact of the use of haploidentical related donors in the access of ethnic/race minority patients to allogeneic transplantation.