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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Single, High Dose Vitamin A Replacement in Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplantation

Conditions
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Allogeneic Hematopoietic Stem Cell Transplantation Recipient

Intervention / Treatment
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* Dietary Supplement: Vitamin A Compound


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prevention (vitamin A compound)<br>Participants receive vitamin A compound PO or enterally once prior to stem cell transplant. once over a given 24 hour period with or without food. We will re-dose at 2000 IU/kg (maximum 120,000 IU) if Week 2 Vitamin A levels remain within 10% of baseline Vitamin A. | Dietary Supplement: Vitamin A Compound<br>* Given PO or enterally<br>* Other names: Vogan;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Determining a Vitamin A dose administered within 14 days prior to transplant that maintains level in the upper quartile of normal range for sex at day 28 (+/- 7 days) after stem cell infusion as well as tolerable in adult allogeneic stem cell transplant recipients. determining a Vitamin A dose administered within 14 days prior to transplant that maintains level in the upper quartile of normal range for sex at day 28 (+/- 7 days) after stem cell infusion as well as tolerable in adult allogeneic stem cell transplant recipients. | Up to day 28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of gastrointestinal graft versus host disease | Cumulative incidence of GI GVHD will be calculated and graphed. | Up to day 180 after stem cell transplant |