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

The Ohio State University

Status: Active, not recruiting

Conditions: Allogeneic Hematopoietic Stem Cell Transplantation Recipient

Treatments: Dietary Supplement: Vitamin A Compound; Other: Best Practice

Study type: Interventional

Funder types: Other

Identifiers

NCT03719092

NCI-2018-01838 (Registry Identifier)

OSU-18078

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 62 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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62 participants in 2 patient groups

Treatment Cohort (vitamin A compound)

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Vitamin A Compound

Control Cohort (usual care)

Active Comparator group

Description:

Patients receive usual care.

Treatment:

Other: Best Practice