Phase II Study of Resistant Potato Starch Plus Deferasirox to Improve Outcomes in Patients Undergoing Allogeneic Stem Cell Transplantation

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Michigan Rogel Cancer Center

About this trial

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 criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Iron chelation
  • Potato Resistant Starch

Treatment groups

50 Participants
are divided into 1 treatment group