Actively Recruiting
Phase II Study of Resistant Potato Starch Plus Deferasirox to Improve Outcomes in Patients Undergoing Allogeneic Stem Cell Transplantation
Led by University of Michigan Rogel Cancer Center · Updated on 2025-11-28
50
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and early effectiveness of combining a commercially available potato-based resistant starch with iron chelation therapy in patients undergoing allogeneic stem cell transplantation (alloHCT). The study aims to see if this combination can increase beneficial butyrate levels and restore normal oxygen conditions in the intestines, potentially reducing acute graft versus host disease (GVHD) and improving survival without GVHD or relapse at 12 months after transplant. Participants will receive iron chelation therapy with deferasirox starting 14 days before transplant and continuing through 100 days after. Resistant potato starch treatment begins 6 days before transplant and also continues through day 100, with patients taking 20g packets twice daily. All participants receive both treatments as part of a single study group. During the study, participants will be monitored for GVHD and relapse-free survival up to one year after transplant. Researchers will assess rates of acute and chronic GVHD, length of event-free survival, and other health outcomes. Participants will be regularly evaluated to track safety and treatment effects throughout the study period, which lasts up to one year post-transplant.
CONDITIONS
Brief Title
Phase II Study of Resistant Potato Starch Plus Deferasirox to Improve Outcomes in Patients Undergoing Allogeneic Stem Cell Transplantation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with hematologic disorders undergoing allo-HCT from fully HLA-matched unrelated or related donors after full-intensity conditioning regimen
- Age 6518 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 will not qualify if you...
- 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
- 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 would pose an unacceptable risk or raise concern about compliance with protocol procedures
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 16 weeks (from day -14 to day +100)
Participants receive iron chelation with deferasirox starting 14 days before the resistant potato starch (RPS) conditioning phase, which begins 6 days before transplantation. Both deferasirox and RPS are taken through 100 days after transplantation.
Visits as per treatment schedule through day +100
Duration - Up to 1 year post-transplantation
Participants are monitored for graft versus host disease (GVHD), relapse-free survival, and other clinical outcomes up to 1 year post-transplantation.
Periodic visits for up to 12 months after treatment completion
Trial Site Locations
Total: 1 location
1
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, United States, 48187
Actively Recruiting
Research Team
M
Mary Riwes
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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