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Phase II Study of Resistant Potato Starch Plus Deferasirox for Allogeneic Stem Cell Transplant

This study is testing if combining resistant potato starch with a medication called deferasirox (Jadenu or Exjade) can improve outcomes for people having an allogeneic stem cell transplant (a procedure where you receive healthy blood-forming cells from a donor). Researchers believe this combination might help by increasing good bacteria in the gut and improving oxygen levels in the intestines, which could reduce a common complication called acute Graft versus Host Disease (GVHD). The study aims to see if this approach is safe and effective in reducing GVHD and improving survival without relapse. You may be able to join if you are an adult with certain blood disorders undergoing this type of transplant. The study is currently unclear on its recruitment status.

Study design
This is an interventional study planning to enroll 50 participants. The phase of the study is not specified.
What's involved
You would receive deferasirox starting 14 days before your transplant and resistant potato starch starting 6 days before, with both continuing for 100 days after the transplant.
Compensation
Not stated in the trial record.
Follow-up
Your progress will be followed for up to 1 year after your transplant to check for GVHD-free and relapse-free survival.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06784336

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
University of Michigan Rogel Cancer Center
~50 participants
Updated 2026-07-21 on ClinicalTrials.gov
What's tested:Iron chelationPotato Resistant Starch

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
GVHD-free and relapse-free survival
Measured over up to 1 year post- transplantation

Conditions

Allogeneic Stem Cell Transplant

Explore related trials

Hematologic Neoplasm

Where it's being run

1 sites across 1 states
Michigan1

Study leadership

  • Mary Riwes · PRINCIPAL_INVESTIGATOR · University of Michigan Rogel Cancer Center

Who to contact

Mary Riwes
[email protected]
734-936-8785
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • GVHD-free and relapse-free survivalup 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.