This phase II trial studies how well resistant potato starch (RPS) when given together with deferasirox works in preventing graft versus host disease (GVHD) in patients undergoing allogeneic hematopoietic stem cell transplantation (allo-HCT). Allo-HCT is a procedure in which a person receives blood-forming stem cells (cells from which all blood cells develop) from a genetically similar, but not identical, donor. This is often a sister or brother, but could be an unrelated donor. Sometimes the transplanted cells from a donor can attack the body's normal cells causing the patient to develop GVHD. GVHD develops in approximately 40-50% of patients undergoing matched related and matched unrelated donor transplants. One of the major factors that can lead to injury or death after transplant is GVHD. Early research has shown that the intestinal microbiome (the bacteria that normally live in an individual's stomach and intestines) may impact whether or not GVHD occurs after transplant. RPS is a dietary supplement made from potato starch. Deferasirox regulates levels of iron in the body. Giving these drugs together may promote changes in the intestinal microbiome in a way which may prevent GVHD.
Additional locations may be listed on ClinicalTrials.gov for NCT06784336.
Locations matching your search criteria
United States
Michigan
Ann Arbor
University of Michigan Comprehensive Cancer CenterStatus: Active
Contact: Mary Mansour Riwes
Phone: 734-936-8785
PRIMARY OBJECTIVE:
I. To assess impact of RPS in combination with iron chelation (along with standard GVHD-prevention strategies) on the incidence of graft versus host disease-free and relapse-free survival (GRFS) at 1 year in recipients of human leukocyte antigen (HLA)-matched allo-HCT with full intensity conditioning regimens.
SECONDARY OBJECTIVES:
I. To measure rates of grade II, III and IV acute GVHD during the study period.
II. To measure rates of chronic GVHD requiring systemic immunosuppression during the study period.
III. To measure event-free survival (time to relapse/progression or death as first event) during the study period.
EXPLORATORY OBJECTIVES:
I. To examine the changes of the intestinal microbiome in patients undergoing allo-HCT.
II. To measure fecal butyrate and levels of other stool metabolites in patients undergoing alloHCT.
III. To measure plasma butyrate and levels of other plasma metabolites in patients undergoing allo-HCT.
IV. To measure serum iron studies in patients undergoing allo-HCT.
V. To measure time to neutrophil engraftment post allo-HCT.
VI. To measure time to platelet cell engraftment post allo-HCT.
VII. Assess red blood cell transfusion dependency.
OUTLINE:
Patients receive deferasirox orally (PO) once daily (QD) on days -14 to +100 and RPS PO twice daily (BID) on days -6 to +100 in the absence of disease progression or unacceptable toxicity. Patients also receive standard of care GVHD prophylaxis regimens per institutional protocols on study. Additionally, patients undergo echocardiography (ECHO) or multigated acquisition scan (MUGA) during screening and blood sample collection throughout the study.
After completion of study treatment, patients are followed up at days +130, +160, and +365.
Lead OrganizationUniversity of Michigan Comprehensive Cancer Center
Principal InvestigatorMary Mansour Riwes
