Recruiting
Phase 2

Potato-Based Starch & Iron Chelation

Sponsor:

University of Michigan Rogel Cancer Center

Code:

NCT06784336

Conditions

Allogeneic Stem Cell Transplant

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Iron chelation

Potato Resistant Starch

Study Details

Brief 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.

Conditions

Allogeneic Stem Cell Transplant

Study ID

NCT06784336

Start date

Oct 15, 2025

Status verified date

Jul, 2026

Completion date

Oct, 2029

Anticipated

Primary completion date

Oct, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 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

Study Design

Enrollment

50 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Study Treatment

All subjects will be enrolled into one arm and will be treated with RPS and Iron Chelation

Interventions

Iron 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

Potato Resistant Starch

Patients will receive PRS beginning on day -6 and continuing through day +100. Patients will take 20g packet twice daily

Primary outcome measure

  • GVHD-free and relapse-free survival [ Time Frame: up to 1 year post- transplantation ]

Central Contacts and Locations

Central contacts

Mary Riwes

734-936-8785mmriwes@umich.edu

Locations

University of Michigan Rogel Cancer Center

Recruiting

Ann Arbor, Michigan, United States, 48187

Contacts

Mary Riwes, D.O.

734-936-8785mmriwes@umich.edu

Principal Investigator:

Mary Riwes

More Information

Sponsor

University of Michigan Rogel Cancer Center

Last update posted

Jul 21, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Michigan Rogel Cancer Center on 2026-07-21.