Resistant potato starch plus iron chelation to reduce complications after allogeneic stem cell transplant
Phase II Multi-center Study of Resistant Potato Starch Plus Deferasirox to Improve Outcomes in Patients Undergoing Allogeneic Stem Cell Transplantation
This Phase II trial will test whether taking resistant potato starch together with the iron chelator deferasirox around an allogeneic stem cell transplant can lower acute graft‑versus‑host disease and improve graft‑versus‑host disease/relapse‑free survival for adult transplant recipients.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Michigan Rogel Cancer Center Academic / other |
| Locations | 1 site (Ann Arbor, Michigan) |
| Trial ID | NCT06784336 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults (≥18) undergoing full‑intensity allogeneic HCT with a fully HLA‑matched related or unrelated donor, with Karnofsky performance status >70% and ability to swallow capsules/tablets, are the intended participants.
Not a fit: Patients with active inflammatory bowel disease requiring treatment, prior gastric bypass surgery, active Clostridium difficile infection, pediatric patients, or those receiving mismatched or reduced‑intensity transplants are unlikely to be eligible or benefit.
Why it matters
Potential benefit: If successful, the combination could lower acute GVHD rates and increase 12‑month GRFS, potentially improving survival and quality of life after transplant.
How similar studies have performed: Preclinical work and small clinical studies targeting the gut microbiome and butyrate have shown promise for reducing GVHD, but combining resistant starch with iron chelation is a relatively novel approach with limited prior clinical data.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Ann Arbor, Michigan
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.