Phase II Study of Resistant Potato Starch Plus Deferasirox to Improve Outcomes in Patients
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.
| Condition(s) | Allogeneic Stem Cell Transplant |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| 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. |
| Who can participate | 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 infe |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | University of Michigan Rogel Cancer Center |
| Locations | Ann Arbor, Michigan, United States |
| Start date | 2025-10-15 |
| NCT ID | NCT06784336 |
| Official listing | https://clinicaltrials.gov/study/NCT06784336 |