Potato Resistant Starch + Iron Chelation for Stem Cell Transplant
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to test the safety and early effectiveness of a potato-based resistant starch combined with iron chelation therapy (a treatment to remove excess iron) for patients receiving stem cell transplants. It targets those with blood disorders receiving a transplant from a closely matched donor. Participants must be able to swallow pills and have a suitable donor ready. The study seeks to determine if this combination can improve outcomes for patients undergoing these transplants. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, if you are receiving treatment for iron overload with deferasirox, you may not be eligible to participate.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that potato-resistant starch is generally safe and practical for patients undergoing stem cell transplants. In earlier studies, patients experienced noticeable changes in their gut bacteria, which were expected and not harmful. Overall, no major safety concerns have been found with using this starch.
Iron chelation therapy is a well-known treatment that helps control iron levels in the body. This is especially important for individuals undergoing hematopoietic stem cell transplants, as iron can sometimes accumulate to harmful levels. Studies have demonstrated that iron chelation therapy can lower this risk without major safety issues.
Both treatments in the study—potato-resistant starch and iron chelation—have shown promising safety in past research. They appear to be well-tolerated, with no serious side effects reported so far.12345Why are researchers excited about this trial's treatments?
Most treatments for conditions requiring stem cell transplants focus on managing symptoms and complications with medications and supportive care. But the combination of Potato Resistant Starch (RPS) and iron chelation offers a novel approach. RPS is unique because it acts as a prebiotic, potentially enhancing gut health and immune function, which are critical for patients undergoing stem cell transplants. Iron chelation helps reduce excess iron in the body, which can be a problem after transplants. Researchers are excited because this dual-action strategy could improve patient outcomes by supporting both gut health and iron balance, tackling two common issues faced by transplant patients.
What evidence suggests that this trial's treatments could be effective for stem cell transplant?
Research has shown that potato resistant starch (RPS) might help increase good bacteria in the gut, benefiting people receiving stem cell transplants. This starch acts like a prebiotic, feeding the helpful bacteria that can reduce complications such as graft-versus-host disease (GVHD) after a transplant. Iron chelation therapy, also included in this trial, lowers iron levels in the body, which is crucial because excess iron can harm patients undergoing stem cell transplants. Effectively managing iron levels can lead to better long-term health for these patients. Both treatments, provided to participants in this trial, show promise in improving the health and recovery of stem cell transplant recipients.13456
Who Is on the Research Team?
Mary Riwes
Principal Investigator
University of Michigan Rogel Cancer Center
Are You a Good Fit for This Trial?
This trial is for adults over 18 with blood disorders who are getting a stem cell transplant from a fully matched donor after intense treatment. They must be able to swallow pills, have good physical function, and understand the study. People can't join if they have certain gut diseases, allergies to iron medicine (deferasirox), are in another GVHD prevention trial, had gastric bypass surgery, active C. difficile infection or need treatment for iron deficiency anemia.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Pre-treatment
Deferasirox intervention begins one week prior to the RPS conditioning phase
Treatment
Participants receive Resistant Potato Starch and Iron Chelation therapy through day +100 post-transplant
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessment of GVHD-free and relapse-free survival
What Are the Treatments Tested in This Trial?
Interventions
- Iron chelation
- Potato Resistant Starch
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Michigan Rogel Cancer Center
Lead Sponsor
National Institutes of Health (NIH)
Collaborator
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator