Phase II Study of Resistant Potato Starch Plus Deferasirox to Improve Outcomes in Patients Undergoing Allogeneic Stem Cell Transplantation

Launched by UNIVERSITY OF MICHIGAN ROGEL CANCER CENTER · Jan 14, 2025

Keywords

ClinConnect Summary

This clinical trial is studying whether a combination of a special type of potato starch and a medication called deferasirox can help improve the health outcomes of patients undergoing allogeneic stem cell transplantation (allo-HCT). Allo-HCT is a procedure where patients receive stem cells from a donor to help treat certain blood disorders. The researchers want to see if this combination treatment can be safe and effective for patients during their recovery.

To be eligible for this trial, participants need to be at least 18 years old and have certain blood disorders that require them to have a stem cell transplant from a fully matched donor. They should also be in good enough health to manage the treatment, which means they can perform daily activities without too much difficulty. Patients should be able to swallow capsules and be willing to sign a consent form to participate. However, some patients may not qualify if they have certain medical conditions, such as active infections or previous surgeries that affect their stomach. Participants in this study will be closely monitored for their health and how they respond to the treatment.

Gender

ALL

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