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

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

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.

PRIMARY OBJECTIVES:

I. . To determine the biologically effective and tolerable dose (BETD) level of pretransplant single, high dose vitamin A supplementation in adult allogeneic stem cell transplant recipients.

SECONDARY OBJECTIVE:

I. To evaluate the feasibility of collecting stool and profiling the gut microbiome in relation to Vitamin A.

OUTLINE: This is a dose-escalation study. Patients are assigned to 1 of 2 cohorts.

TREATMENT COHORT: Patients receive vitamin A compound orally (PO) or enterally once prior to stem cell transplant. Patients may receive vitamin A compound PO or enterally two weeks after stem cell transplant if vitamin A levels have not improved by at least 10%.

CONTROL COHORT: Patients receive usual care.

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

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