Single high-dose vitamin A given with allogeneic stem cell transplant

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, double-blind Phase 2 trial comparing a single large oral dose of vitamin A to a placebo in adults undergoing allogeneic hematopoietic stem cell transplantation who receive peripheral blood stem cell grafts. The trial enrolls patients with acceptable liver tests and a vitamin A level below the age-based upper limit of normal and excludes those with raised intracranial pressure, liver cirrhosis, or pregnancy. Investigators will monitor for the development of moderate-to-severe chronic graft-versus-host disease, with particular attention to gastrointestinal GVHD, and will track safety and liver function after dosing. The design builds on preliminary data linking lower vitamin A levels to increased GI GVHD risk and tests whether supplementation at transplant can reduce that risk.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Be 18 years of age or older
* Be scheduled for allogeneic stem cell transplant.
* Have a vitamin A level \< upper limit of normal for age.
* Be able to tolerate enteral vitamin dose administration.
* Have a total bilirubin level \< 1.5x ULN and an AST and/or ALT\< 3xULN for age
* Receiving PBSCs as stem cell graft

Exclusion Criteria:

* Ongoing raised intracranial pressure (see appendix D for definition of raised intracranial pressure)
* Liver cirrhosis (see appendix C for definition of liver cirrhosis)
* Patients will be excluded if they are currently pregnant.
* Patients will be excluded if they have a fish (not shellfish) allergy.

Where it's running

• Moffitt Cancer Center
  Tampa, Florida, United States Recruiting
• Roswell Park Comprehensive Cancer Center
  Buffalo, New York, United States Recruiting
• The Ohio State University
  Columbus, Ohio, United States Recruiting

Study contacts

• Principal investigator: Pooja Khandelwal, MD — Children's Hospital Medical Center, Cincinnati
• Study coordinator: Celeste Dourson, MS, CCRP
• Email: celeste.dourson@cchmc.org
• Phone: 513-636-7679

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.