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IS-free Treg HaploHCT

Clinical Trial: NCT04678401

For more details on this clinical trial, including contact information, please see this trial’s listing on clinicaltrials.gov:
Purpose: 

This research study is evaluating the safety and efficacy of the IS-free Treg-cell graft-engineered haplo transplant method in people with relapsed/refractory acute myeloid leukemia (AML) and/or myelodysplastic syndromes (MDS) receiving a haploidentical donor allogeneic hematopoietic stem cell transplant (HSCT).

The names of the study interventions involved in this study are:

  • Radiation-Total Myeloid and Lymphoid Irradiation (TMLI
  • Chemotherapy (Fludarabine, Thiotepa, Cyclophosphamide plus Mesna)
  • Infusion of haplo Treg-enriched donor cells (experimental therapy)
  • Infusion of unmodified haplo donor T cells (includes cancer-fighting T effector cells)
  • Infusion of haplo donor CD34+ Peripheral Blood Stem Cells
Status: 
Not yet recruiting
Study Date: 
Tue, 12/22/2020 ( ) to Tue, 10/31/2023 ( )
Bone Marrow Disease(s): 
  • acute myeloid leukemia (AML)
  • graft versus host disease (GVHD)
  • myelodysplastic syndromes (MDS)
Intervention: 
Experimental: IS-FREE TREG CRAFT_ENGINEERED HaploHCT After meeting eligibility criteria and being enrolled, patients will receive: Day -15 to -6 prior to hematopoietic stem cell transplant (HSCT), preparatory regimen of radiation and chemotherapy: Total Myeloid and Lymphoid Irradiation (TMLI): Days -15 to -11 prior to HSCT; - Chemotherapy (infusion): Day -10 to day -6 prior to HSCT: Fludarabine (all days), Thiotepa (days -10 and -9) and Cyclophosphamide and Mesna (days -8 and -7) Day -4 prior to (HSCT), a Treg-enriched donor cell infusion and graft vs host disease (GVHD) assessment Day -1 prior to (HSCT), a unmodified donor T Cell infusion and (GVHD) assessment Day of (day 0) (HSCT), CD34+ Haplo Peripheral Blood Stem Cell Infusion/Transplant and (GVHD) assessment Days 30, 60,100, 180, 365 post hematopoietic stem cell transplant (HSCT), participants will undergo testing and assessment of minimal residual disease (MRD) and (GVHD) Radiation: Radiation Total Myeloid and Lymphoid Irradiation (TMLI) delivered through Radiation Oncology institutional standards Other Name: Radiotherapy Drug: Fludarabine Given intravenously -10 to -6 days prior to hematopoietic stem cell transplant (HSCT) Other Name: Fludara Drug: Thiotepa Given intravenously on day -10 and day- 9 prior to hematopoietic stem cell transplant (HSCT) Other Name: Tepadina Drug: Cyclophosphamide Given intravenously with Mesna on day -8 and day- 7 prior to hematopoietic stem cell transplant (HSCT) Other Name: cytophosphane Drug: Mesna Given intravenously with Cyclophosphamide on day -8 and day -7 prior to hematopoietic stem cell transplant (HSCT) Other Name: Mesnex Biological: Treg-enriched donor cell Given intravenously -4 day prior to hematopoietic stem cell transplant (HSCT) Biological: Unmodified donor T Cell Given intravenously -1 day prior to hematopoietic stem cell transplant (HSCT) Procedure: CD34+ Haplo Peripheral Blood Stem Cell CD34+ Haplo Peripheral Blood Stem Cell Transplantation
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