Phase II Study of Resistant Potato Starch Plus Deferasirox to Improve Outcomes in Patients Undergoing Allogeneic Stem Cell Transplantation
Start Date
10/15/2025
Completion Date
10/1/2029
Summary
The study will evaluate the safety and early efficacy of administering the combination of a commercially available potato-based resistant starch along with iron chelation therapy to subjects undergoing alloHCT.
Detailed Description
The deferasirox intervention will begin one week prior to the RPS (Resistant Potato Starch) conditioning phase and both will continue through day +100. The study hypothesis is that a short-term administration of a resistant starch and iron chelation therapy will be capable of both increasing levels of butyrate within the intestine and restoring physiological hypoxia in the intestines, which together will reduce rates of acute GVHD (Graft versus Host Disease) and improve the clinically meaningful outcome of GRFS (Graft versus Host Disease / Relapse-Free Survival) at 12 months post-transplant. 21NOV2025- The grant previously listed on this trial is associated with the conduct of a preliminary study NCT02763033. Therefore, it was removed from this clinical trial as it is not being used for the conduct of this study.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Iron chelation
Potato Resistant Starch
Conditions
Locations
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan 48187
United States