Phase II Multi-center Study of Resistant Potato Starch Plus Deferasirox to Improve Outcomes in Patients Undergoing Allogeneic Stem Cell Transplantation
University of Michigan Rogel Cancer Center
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.
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.…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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 * Ability to understand and the willingness to sign a written informed consent * Availability of a full-HLA matched related or unrelated donor who is medically eligible to donate cells according to the National Marrow Donor Program criteria Exclusion Criteria: * Patients with active inflammatory bowel di…
Interventions
- DrugIron chelation
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
- DrugPotato Resistant Starch
Patients will receive PRS beginning on day -6 and continuing through day +100. Patients will take 20g packet twice daily
Location
- University of Michigan Rogel Cancer CenterAnn Arbor, Michigan