Clinical trial NCT06784336: Phase II Study of Resistant Potato Starch Plus Deferasirox to Improve Outcomes in Patients Undergoing Allogeneic Stem Cell Transplantation
Official title: Phase II Multi-center Study of Resistant Potato Starch Plus Deferasirox to Improve Outcomes in Patients Undergoing Allogeneic Stem Cell Transplantation
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Allogeneic Stem Cell Transplant
Lead sponsor: University of Michigan Rogel Cancer Center
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2025-01-20
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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.

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

Primary outcomes:
measure: GVHD-free and relapse-free survival
timeFrame: up to 1 year post- transplantation
Secondary outcomes:
measure: Rates of grade II, III and IV acute GVHD
timeFrame: up to 1 year post- transplantation
measure: Rates of chronic GVHD requiring systemic immunosuppression
timeFrame: up to 1 year post- transplantation
measure: Length of event-free survival
timeFrame: up to 1 year post- transplantation
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Rogel Cancer Center
state: Michigan
Study officials:
affiliation: University of Michigan Rogel Cancer Center
name: Mary Riwes
role: PRINCIPAL_INVESTIGATOR
References: