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

  • STATUS
    Recruiting
  • End date
    Dec 31, 2022
  • participants needed
    34
  • sponsor
    Ohio State University Comprehensive Cancer Center
Updated on 26 April 2022

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.

Description

PRIMARY OBJECTIVES:

I. To assess the feasibility and safety of pre-transplant single, high dose vitamin A supplementation in adult allogeneic stem cell transplant recipients until day +28 after transplant.

OUTLINE: This is a dose-escalation study.

Participants receive vitamin A compound orally (PO) or enterally once prior to stem cell transplant.

After completion of study treatment, participants are followed up periodically.

Details
Condition Allogeneic Hematopoietic Stem Cell Transplantation Recipient
Treatment Vitamin A Compound
Clinical Study IdentifierNCT03719092
SponsorOhio State University Comprehensive Cancer Center
Last Modified on26 April 2022

Eligibility

Yes No Not Sure

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
Baseline pre-transplant Vitamin A levels higher than the upper quartile of normal range for age
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
Pregnancy
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