Acute Myeloid Leukemia Clinical Trial
Official title:
Reduced Intensity Haploidentical Peripheral Blood Stem Cell Transplantation With Post-transplant Cyclophosphamide and Sirolimus/Mycophenolate Mofetil/RGI-2001 Based GVHD Prevention: a Pilot Study
This research study is studying the RGI-2001 for preventing Graft-vs-Host Disease (GVHD) in people with acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), myelodysplastic syndrome (MDS), myeloproliferative disorders (MPN), chronic myelomonocytic leukemic (CMML), chemosensitive hodgkin lymphoma (HL), or Non-Hodgkin lymphoma (NHL).who will have a blood stem cell transplantation. - GVHD is a condition in which cells from the donor's tissue attack the organs. - RGI-2001 is an investigational treatment
- This is a pilot study in subjects undergoing reduced-intensity haploidentical peripheral blood stem cell transplantation who will receive graft-versus-host disease prevention with post-transplant cyclophosphamide, followed by sirolimus, mycophenolate mofetil, and RGI-2001. - The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits. - The standard of care drugs of fludarabine, cyclophosphamide, melphalan, radiation, sirolimus, and mycophenolate mofetil are all FDA approved. - Eligible Participants will be placed in 1 of 2 groups, per physicians discretion: - Regimen #1 : - Before stem cell transplant:Fludarabine + Cyclophosphamide + Radiation - After stem cell transplant: Cyclophosphamide + Sirolimus +Mycophenolate mofetil + RGI-2001 - Regimen #2 - Before stem cell transplant: fludarabine + melphalan + radiation - After stem cell transplant: cyclophosphamide + sirolimus +Mycophenolate mofetil + RGI-2001 - A total of 20 participants will be enrolled to this trial - The U.S. Food and Drug Administration (FDA) has not approved RGI-2001 as a treatment for any disease. ;
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