A Randomized, Multicenter, Phase III Trial of Tacrolimus / Methotrexate Versus Post-Transplant Cyclophosphamide / Tacrolimus / Mycophenolate Mofetil in Non-Myeloablative / Reduced Intensity Conditioning Allogeneic Peripheral Blood Stem Cell Transplantation (BMT CTN #1703; Progress III); Companion Study: Microbiome and Immune Reconstitution in Cellular Therapies and Hematopoietic Stem Cell Transplantation (BMT CTN #1801; Mi-Immune)
Myelodysplastic Syndromes (MDS)
18 Years and older, Male and Female
1703: The study is designed as a randomized, phase III, multicenter trial comparing two acute graft-versus-host disease (aGVHD) prophylaxis regimens: tacrolimus / methotrexate (Tac / MTX) versus post-transplant cyclophosphamide / tacrolimus / mycophenolate mofetil (PTCy / Tac / MMF) in the setting of reduced intensity conditioning (RIC) allogeneic peripheral blood stem cell (PBSC) transplantation. 1801: The goal of this protocol is to test the primary hypothesis that the engraftment stool microbiome diversity predicts one-year non-relapse mortality in patients undergoing reduced intensity allogeneic HCT.
1703: Graft-versus-Host Disease (GVHD) is a complication that affects many hematopoietic stem
cell transplant (HSCT) patients; it occurs when the new cells from a transplant attack the
recipient's body. The current standard GVHD prophylaxis regimen for patients with hematologic
malignancies undergoing HSCT involves a combination of immunosuppressive agents given for the
first 6 months after transplant.
The standard strategy of Tacrolimus/Methotrexate will be used as a control arm in comparison
to one other treatment plan utilizing Tacrolimus/Mycophenolate Mofetil/Post-Transplant
Cyclophosphamide. Study participants will receive an infusion of mobilized peripheral blood
stem cell grafts on both arms. Study participants will be randomized to one of these two
1801: A relationship between the intestinal microbiota and graft-versus-host disease (GVHD)
has long been appreciated but is still not well understood. Mice transplanted in germ-free
conditions or treated with gut-decontaminating antibiotics developed less severe GVHD.
Clinical studies initially suggested a benefit from near-total bacterial decontamination, but
later showed no clear benefit and this approach was discontinued in the early 1990s. Partial
gut decontamination continues to be practiced at many centers. More recently, the advent of
next-generation sequencing (NGS) has resulted in cheaper and easier characterization of
complex microbial mixtures. This has led to a renewed interest in evaluating the relationship
between the microbiota and human health and disease, including recipients of hematopoietic
cell transplantation (HCT). Similarly, NGS has also contributed to significant advancements
in the investigator's understanding of immune reconstitution in HCT patients and how this may
impact clinica outcomes.
The goal of this protocol is to test the primary hypothesis that the engraftment stool
microbiome diversity predicts one-year non-relapse mortality in patients undergoing reduced
intensity allogeneic HCT.
Treatment Sites in Georgia
5670 Peachtree Dunwoody Road
Atlanta, GA 30342
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