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| ID | Type | Description | Link |
|---|---|---|---|
| HUM00262804 | Other Identifier | University of Michigan |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Treatment | Experimental | All subjects will be enrolled into one arm and will be treated with RPS and Iron Chelation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Iron chelation | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| GVHD-free and relapse-free survival | 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. | up to 1 year post- transplantation |
| Measure | Description | Time Frame |
|---|---|---|
| Rates of grade II, III and IV acute GVHD | Cumulative incidence of grades II to IV GVHD and of grades III to IV acute GVHD | up to 1 year post- transplantation |
| Rates of chronic GVHD requiring systemic immunosuppression |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mary Riwes | Contact | 734-936-8785 | mmriwes@umich.edu |
| Name | Affiliation | Role |
|---|---|---|
| Mary Riwes | University of Michigan Rogel Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan Rogel Cancer Center | Recruiting | Ann Arbor | Michigan | 48187 | United States |
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| Potato Resistant Starch | Drug | Patients will receive PRS beginning on day -6 and continuing through day +100. Patients will take 20g packet twice daily |
|
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Cumulative incidence of chronic GVHD warranting systemic immunosuppression
| up to 1 year post- transplantation |
| Length of event-free survival | time to relapse/progression or death as first event | up to 1 year post- transplantation |
| ID | Term |
|---|---|
| D007502 | Iron Chelating Agents |
| D000077588 | Deferasirox |
| ID | Term |
|---|---|
| D002614 | Chelating Agents |
| D064449 | Sequestering Agents |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D020313 | Specialty Uses of Chemicals |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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