Haplo Peripheral Blood Sct In GVHD Prevention
brief summary
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
detailed description
* 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.
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