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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
25
predetermined dose, intravenously, a predetermined times per cycle Given in both pre stem cell and post stem cell cycles
◦Cyclophosphamide predetermined dose, predetermined number of times in Given in pre-stem cell Regimen #1 Cyclophosphamide predetermined dose, predetermined number of times in cycle, intravenous infusion
Total body irradiation (TBI) once per cycle.
Melphalan, infusion, determined dosage, once per cycle
Sirolimus: Predetermined dosage, predetermined number of time in cycle, oral: Please note that doses of sirolimus can be adjusted at the treating physician's discretion given the multiple drugs and other situations which affect its metabolism
◦Mycophenolate mofetil, oral or iv(predetermined dose or IV TID (based upon actual body weight), at predetermined times per cycle
IV, predetermined dose, weekly to 6 total doses
◦Given in Post Stem Cell cycle of Regimen #1 and #2 Cyclophosphamide predetermined dose, predetermined number of times in cycle, intravenous infusion
Massachusetts General Hospital
Boston, Massachusetts, United States
Number of patients achieving successful donor engraftment
(absolute neutrophil count \> 500/uL and ≥ 90% donor cell chimerism)
Time frame: 60 Days
100-day non-relapse mortality (NRM) rate.
The regimen will be considered as safe if 100d NRM rate is \<=5%, and not safe if 100d NRM rate is ≥25%.
Time frame: 100 Days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.