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

Phase 2

Not yet recruiting

• Conditions: Allogeneic Stem Cell Transplant
• Interventions: Drug: Iron chelation; Drug: Potato Resistant Starch

• Registration Number: NCT06784336
• Lead Sponsor: University of Michigan Rogel Cancer Center

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.

Detailed Description

The deferasirox intervention will begin one week prior to the RPS (Resistant Potato Starch) conditioning phase and both will continue through day +100. The study hypothesis is that a short-term administration of a resistant starch and iron chelation therapy will be capable of both increasing levels of butyrate within the intestine and restoring physiological hypoxia in the intestines, which together will reduce rates of acute GVHD (Graft versus Host Disease) and improve the clinically meaningful outcome of GRFS (Graft versus Host Disease / Relapse-Free Survival) at 12 months post-transplant.

Study Timeline

• Study First Submitted: 2025-01-14
• Study First Submitted QC: 2025-01-14
• Study First Posted: 2025-01-20
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-08
• Last Update Posted: 2025-05-11
• Study Start: 2025-08
• Primary Completion: 2028-08
• Study Completion: 2029-08

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Study Treatment	Iron chelation	All subjects will be enrolled into one arm and will be treated with RPS and Iron Chelation
Study Treatment	Potato Resistant Starch	All subjects will be enrolled into one arm and will be treated with RPS and Iron Chelation

Primary Outcome Measures

Name	Time	Method
GVHD-free and relapse-free survival	up to 1 year post- transplantation	Assessed in a time-to-event analysis, with GRFS defined as the first occurrence of grade III or IV acute GVHD, chronic GVHD warranting systemic immunosuppression, disease relapse or progression, or death from any cause.

Secondary Outcome Measures

Name	Time	Method
Rates of grade II, III and IV acute GVHD	up to 1 year post- transplantation	Cumulative incidence of grades II to IV GVHD and of grades III to IV acute GVHD
Rates of chronic GVHD requiring systemic immunosuppression	up to 1 year post- transplantation	Cumulative incidence of chronic GVHD warranting systemic immunosuppression
Length of event-free survival	up to 1 year post- transplantation	time to relapse/progression or death as first event

Trial Locations

Locations (1)

University of Michigan Rogel Cancer Center; 🇺🇸 Ann Arbor, Michigan, United States