RECRUITING

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

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Allogeneic Stem Cell Transplant

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-09
Study Completion:2029-09
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06784336

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patients with hematologic disorders undergoing allo-HCT from fully HLA-matched unrelated or related donors after full-intensity conditioning regimen
  2. * Age ≥18 years
  3. * Karnofsky performance status \>70%, see Appendix A
  4. * Patients must be able to swallow capsules/tablets
  5. * Ability to understand and the willingness to sign a written informed consent
  6. * 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
  1. * Patients with active inflammatory bowel disease requiring treatment per treating investigator
  2. * Patients with a history of gastric bypass surgery
  3. * 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
  4. * Patients with active iron deficiency anemia requiring treatment
  5. * Patients with iron overload receiving active treatment with deferasirox
  6. * Known hypersensitivity to deferasirox or any component of Jadenu or Exjade
  7. * Patients actively enrolled on treatment or in follow up phase on any other GVHD prevention trial
  8. * 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

Contacts and Locations

Study Contact

Mary Riwes
CONTACT
734-936-8785
mmriwes@umich.edu

Principal Investigator

Mary Riwes
PRINCIPAL_INVESTIGATOR
University of Michigan Rogel Cancer Center

Study Locations (Sites)

University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, 48187
United States

Collaborators and Investigators

Sponsor: University of Michigan Rogel Cancer Center

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-09
Study Completion Date2029-09

Study Record Updates

Study Start Date2025-09
Study Completion Date2029-09

Terms related to this study

Additional Relevant MeSH Terms

  • Allogeneic Stem Cell Transplant