Phase II Study of Resistant Potato Starch Plus Deferasirox to Improve Outcomes in Patients Undergoing Allogeneic Stem Cell Transplantation
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
50 participants
Oct 15, 2025
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria6
- 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 Criteria8
- 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
- Patients with iron overload receiving active treatment with deferasirox
- Known hypersensitivity to deferasirox or any component of Jadenu or Exjade
- Patients actively enrolled on treatment or in follow up phase on any other GVHD prevention trial
- Any physical or psychological condition that, in the opinion of the investigator, would pose an unacceptable risk to the patient or raise concern that the patient would not comply with protocol procedures
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Interventions
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
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06784336