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

NCT ID: NCT06784336

Last Updated: 2025-11-28

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-15
• Study Completion Date: 2029-10-31

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.

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.

Conditions

Allogeneic Stem Cell Transplant

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Study Treatment

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

Group Type: EXPERIMENTAL

Iron chelation

Intervention Type: 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

Potato Resistant Starch

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

Potato Resistant Starch

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

Intervention Type: DRUG

Other Intervention Names

Deferasirox; Bob's Red Mill

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Michigan Rogel Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mary Riwes

Role: PRINCIPAL_INVESTIGATOR

University of Michigan Rogel Cancer Center

Locations

University of Michigan Rogel Cancer Center

Ann Arbor, Michigan, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Mary Riwes

Role: CONTACT

mmriwes@umich.edu

734-936-8785

Facility Contacts

Mary Riwes, D.O.

Role: primary

mmriwes@umich.edu

734-936-8785

Other Identifiers

HUM00262804

Identifier Type: OTHER

Identifier Source: secondary_id

UMCC 2024.092

Identifier Type: -

Identifier Source: org_study_id