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Completed
NCT03719092
High Dose Vitamin A in Preventing Gastrointestinal GVHD in Participants Undergoing Donor Stem Cell Transplant
Conditions: Allogeneic Hematopoietic Stem Cell Transplantation Recipient
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 62
Sponsor: Ohio State University Comprehensive Cancer Center
Location: Ohio State University Comprehensive Cancer Center Columbus Ohio
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.
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT03719092). StuddyBuddy aggregates publicly available trial information.