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

NCT06784336 | Recruiting Phase 2 FDA Drug

• 2 other identifiers: UMCC 2024.092HUM00262804
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Allogeneic Stem Cell Transplant

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Rates of grade II, III and IV acute GVHD

  up to 1 year post- transplantation

• Rates of chronic GVHD requiring systemic immunosuppression

  up to 1 year post- transplantation

• Length of event-free survival

  up to 1 year post- transplantation

Study Arms (1)

Study Treatment

EXPERIMENTAL

All subjects will be enrolled into one arm and will be treated with RPS and Iron Chelation

Drug: Iron chelation; Drug: Potato Resistant Starch

Interventions

Iron chelation DRUG

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

Also known as: Deferasirox

Study Treatment

Potato Resistant Starch DRUG

Patients will receive PRS beginning on day -6 and continuing through day +100. Patients will take 20g packet twice daily

Also known as: Bob's Red Mill

Study Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan Rogel Cancer Center: lead

Study Sites (1)

University of Michigan Rogel Cancer Center

Ann Arbor, Michigan, 48187, United States

RECRUITING

MeSH Terms

Interventions

Iron Chelating Agents; Deferasirox

Intervention Hierarchy (Ancestors)

Chelating Agents; Sequestering Agents; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Mary Riwes

  University of Michigan Rogel Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mary Riwes

CONTACT

734-936-8785; mmriwes@umich.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2025
• First Posted: January 20, 2025
• Study Start: October 15, 2025
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): October 1, 2029
• Last Updated: November 28, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)