Active — Not RecruitingNot Applicable

High Dose Vitamin A in Preventing Gastrointestinal GVHD in Participants Undergoing Donor Stem Cell Transplant

United States62 participantsStarted 2020-02-07

Plain-language summary

This phase I trial studies the side effects and how well high dose vitamin A works in preventing gastrointestinal graft versus host disease (GVHD) in participants undergoing donor stem cell transplant. Vitamin A deficiency is associated with increased risk of gastrointestinal GVHD. Vitamin A regulates growth and differentiation of intestinal cells and may reduce risk of gastrointestinal GVHD.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Adult patients planned to undergo an allogeneic stem cell transplant (SCT) with an human leukocyte antigen (HLA)-matched (unrelated or related) or 1 allele mismatched (7/8) donor or haploidentical donor who received either myeloablative or nonmyeloablative conditioning for hematologic malignancies are eligible Exclusion Criteria: * Vitamin A hypersensitivity or allergy * Abnormal liver enzymes outside of the institutional laboratory normal range within 30 days of screening * Abnormal total, indirect, or direct bilirubin outside of the institutional laboratory normal range within 30 days of screening * Enteral feeding intolerance * Medication intolerance - history of allergic reaction to Vitamin A or other history of discontinuation to study drug due to adverse effect * Pregnancy

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Vitamin A dose that achieves level in the upper quartile of normal range for sex in at least 2/3 cases without dose limiting toxicity

Timeframe: Up to day 28

Trial details

NCT IDNCT03719092

SponsorOhio State University Comprehensive Cancer Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-04-30

View on ClinicalTrials.gov More Allogeneic Hematopoietic Stem Cell Transplantation Recipient trials