Spots Global Cancer Trial Database for Safety and Early Efficacy Study of TBX-2400 in Patients With AML or Myelofibrosis
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Trial Identification
Brief Title: Safety and Early Efficacy Study of TBX-2400 in Patients With AML or Myelofibrosis
Official Title: A Phase I Study to Assess the Safety and Early Efficacy of TBX-2400 in Enhancing Engraftment in Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplant for the Treatment of Acute Myelogenous Leukemia or Myelofibrosis
Study ID: NCT04709458
Interventions
Study Description
Brief Summary: This is a study of allogeneic stem cell transplantation with TBX-2400 in adult subjects with Acute Myelogenous Leukemia (AML) or Myelofibrosis (MF). The donor cells are exposed to a protein that has been shown in the laboratory to improve the ability of the donor cells to make blood and immune cells after transplant. Exposure of the donor cells to this protein does not modify the genes in the cells in any way. This study has two goals. The first goal is to find out if transplant with TBX-2400 is safe. The second goal is to find out what effects TBX-2400 stem cells have on time to engraftment in adult subjects with AML or MF. The study hypothesis is that TBX-2400 cells will shorten the time to immune reconstitution after transplant.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University Hospital Centre Zagreb, Zagreb, , Croatia
Fondazione Policlinico Universitario Agostino Gemelli, Roma, , Italy
Contact Details
Name: Andrea Bacigalupo, MD
Affiliation: Unit for Hematology and BMT, Fondazione Policlinico Universitario Agostino Gemelli, Rome, Italy
Role: PRINCIPAL_INVESTIGATOR
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