Resistant potato starch plus iron chelation to reduce complications after allogeneic stem cell transplant

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase II, single‑center interventional trial at the University of Michigan Rogel Cancer Center testing a combination of a commercially available resistant potato starch (RPS) and the oral iron chelator deferasirox given to adults undergoing full‑intensity allogeneic hematopoietic cell transplantation from fully HLA‑matched donors. Deferasirox begins one week before the RPS conditioning phase and both interventions continue through day +100 after transplant. The study's hypothesis is that the combination will raise intestinal butyrate levels and restore physiological hypoxia in the gut, which together will reduce acute GVHD and improve 12‑month GRFS. Participants must meet standard transplant eligibility (age ≥18, Karnofsky >70%, able to swallow oral medication) and will be followed for clinical outcomes including acute GVHD and GRFS.

Why it matters

Who can join: the full rules

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

Where it's running

• University of Michigan Rogel Cancer Center
  Ann Arbor, Michigan, United States Recruiting

Study contacts

• Principal investigator: Mary Riwes — University of Michigan Rogel Cancer Center
• Study coordinator: Mary Riwes
• Email: mmriwes@umich.edu
• Phone: 734-936-8785

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.