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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Allogeneic Stem Cell Transplant
• Intervention / Treatment: Drug: Iron chelation; Drug: Potato Resistant Starch

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.

21NOV2025- The grant previously listed on this trial is associated with the conduct of a preliminary study NCT02763033. Therefore, it was removed from this clinical trial as it is not being used for the conduct of this study.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Mary Riwes; Phone Number: 734-936-8785; Email: mmriwes@umich.edu

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48187
      • Recruiting
      • University of Michigan Rogel Cancer Center
      • Contact: Mary Riwes, D.O.; Phone Number: 734-936-8785; Email: mmriwes@umich.edu
      • Principal Investigator: Mary Riwes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Study Treatment; All subjects will be enrolled into one arm and will be treated with RPS and Iron Chelation	Drug: Iron chelation; Patients will receive Iron chelation with deferasirox (Jadenu 7 mg/kg/day preferred versus Exjade 10 mg/kg/day) beginning on day -14 and continuing through day +100; Other Names: Deferasirox; Drug: Potato Resistant Starch; Patients will receive PRS beginning on day -6 and continuing through day +100. Patients will take 20g packet twice daily; Other Names: Bob's Red Mill

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
GVHD-free and relapse-free survival	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.	up to 1 year post- transplantation

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Michigan Rogel Cancer Center
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI); National Institutes of Health (NIH)
• Investigators: Principal Investigator: Mary Riwes, University of Michigan Rogel Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2025
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): October 1, 2029

Study Registration Dates

• First Submitted: January 14, 2025
• First Submitted That Met QC Criteria: January 14, 2025
• First Posted (Actual): January 20, 2025

Study Record Updates

• Last Update Posted (Actual): November 28, 2025
• Last Update Submitted That Met QC Criteria: November 21, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Chelating Agents; Sequestering Agents; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Azoles; Pharmacologic Actions; Chemical Actions and Uses; Hydrocarbons; Hydrocarbons, Cyclic; Carboxylic Acids; Hydrocarbons, Aromatic; Benzene Derivatives; Specialty Uses of Chemicals; Acids, Carbocyclic; Benzoates; Triazoles; Deferasirox; Iron Chelating Agents
• Other Study ID Numbers: UMCC 2024.092; HUM00262804 (Other Identifier: University of Michigan)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No