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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Patients will receive Iron chelation with deferasirox (Jadenu 7 mg/kg/day preferred versus Exjade 10 mg/kg/day) beginning on day -14 and continuing through day +100
Patients will receive PRS beginning on day -6 and continuing through day +100. Patients will take 20g packet twice daily
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, United States
RECRUITINGGVHD-free and relapse-free survival
Assessed in a time-to-event analysis, with GRFS defined as the first occurrence of grade III or IV acute GVHD, chronic GVHD warranting systemic immunosuppression, disease relapse or progression, or death from any cause.
Time frame: up to 1 year post- transplantation
Rates of grade II, III and IV acute GVHD
Cumulative incidence of grades II to IV GVHD and of grades III to IV acute GVHD
Time frame: up to 1 year post- transplantation
Rates of chronic GVHD requiring systemic immunosuppression
Cumulative incidence of chronic GVHD warranting systemic immunosuppression
Time frame: up to 1 year post- transplantation
Length of event-free survival
time to relapse/progression or death as first event
Time frame: up to 1 year post- transplantation
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