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
This study is assessing whether the IS-free Treg-cell graft-engineered haplo HSCT) approach
will reduce risk of relapse while preventing usual toxicities related to stem cell
transplants (e.g., graft-versus-host-disease (GVHD)). GVHD is a complication of
transplantation where the T cells (a type of white blood cell that helps protect the body
from relapse by killing cancer cells) in the donor graft attack and damage some of the host
tissues. Patients who receive an allogeneic (using another person as the donor) hematopoietic
stem cell transplant (HSCT) may develop graft-versus-host disease (GVHD) toxicity and are
also at risk of disease relapse.
The research study procedures include: screening for eligibility and study treatment
including evaluations and follow up visits.
Participants will receive the study intervention Treg-enriched donor cells and will then be
followed for 1 year after transplantation.
It is expected that about 10 people will take part in this research study.
Dana-Farber Cancer Institute research funds along with charitable donations are supporting
this research study. Regeneron Pharmaceuticals, Inc. (a pharmaceutical company) is also
supporting this research study by providing funding and support for correlative laboratory
Stem Cell Transplant Complications, Graft Vs Host Disease, Myeloid Leukemia, Acute, Myeloid Leukemia in Relapse (Disorder), Myelodysplastic Syndromes
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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