Phase II Study of Resistant Potato Starch Plus Deferasirox to Improve Outcomes in Patients Undergoing Allogeneic Stem Cell Transplantation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Iron chelation, Potato Resistant Starch.
- Who it may be relevant to
- Registry conditions: Allogeneic Stem Cell Transplant. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Phase II Multi-center Study of Resistant Potato Starch Plus Deferasirox to Improve Outcomes in Patients Undergoing Allogeneic Stem Cell Transplantation
Overview
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.
Detailed description
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.
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
Primary outcome measures
- GVHD-free and relapse-free survival [Time frame: up to 1 year post- transplantation]
Secondary outcome measures (3)
- Rates of grade II, III and IV acute GVHD [Time frame: up to 1 year post- transplantation]
- Rates of chronic GVHD requiring systemic immunosuppression [Time frame: up to 1 year post- transplantation]
- Length of event-free survival [Time frame: up to 1 year post- transplantation]
Eligibility criteria
Inclusion criteria
- 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 criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- University of Michigan Rogel Cancer Center — Ann Arbor
Identifiers
NCT: NCT06784336 · UMCC 2024.092 · HUM00262804