Phase II Study of Resistant Potato Starch Plus Deferasirox to Improve Outcomes in Patients Undergoing Allogeneic Stem Cell Transplantation
NCT06784336 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50
Last updated 2025-11-28
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
Interventions
- DRUG
-
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
- DRUG
-
Potato Resistant Starch
Patients will receive PRS beginning on day -6 and continuing through day +100. Patients will take 20g packet twice daily
Sponsors & Collaborators
-
University of Michigan Rogel Cancer Center
lead OTHER
Principal Investigators
-
Mary Riwes · University of Michigan Rogel Cancer Center
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-10-15
- Primary Completion
- 2028-10-31
- Completion
- 2029-10-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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