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.
Patients with hematologic disorders undergoing allo-HCT from fully HLA-matched unrelated or related donors after full-intensity conditioning regimen
Age ≥18 years
Karnofsky performance status >70%, see Appendix A
Patients must be able to swallow capsules/tablets
Patients with active inflammatory bowel disease requiring treatment per treating investigator
Patients with a history of gastric bypass surgery
Patients with active Clostridium difficile infection at the time of study enrollment. Active infection is defined as a stool sample positive for Clostridium difficile toxin via enzyme immunoassay (EIA) and either symptoms (frequent loose stools) OR imaging findings consistent with toxic megacolon
Patients with active iron deficiency anemia requiring treatment
Single group
Iron chelation
DrugPatients 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
Potato Resistant Starch
DrugPatients will receive PRS beginning on day -6 and continuing through day +100. Patients will take 20g packet twice daily
GVHD-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.
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
Rates of chronic GVHD requiring systemic immunosuppression
Cumulative incidence of chronic GVHD warranting systemic immunosuppression
Length of event-free survival
time to relapse/progression or death as first event
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