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.

Study Overview

• Status: Recruiting
• Conditions: Allogeneic Hematopoietic Stem Cell Transplantation Recipient
• Intervention / Treatment: Dietary supplement: Vitamin A Compound

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 34
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rachel Dalton; Email: Rachel.Dalton@osumc.edu
• Study Contact Backup: Name: Ohio State University Comprehensive Cancer Center; Phone Number: 800-293-5066; Email: OSUCCCClinicaltrials@osumc.edu

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Recruiting
      • Ohio State University Comprehensive Cancer Center
      • Principal Investigator: Hannah Choe, MD
      • Contact: Hannah Choe, MD; Phone Number: 614-293-5428; Email: Hannah.Choe@osumc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Prevention (vitamin A compound); 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; Given PO or enterally; Other Names: Vitamin A; A 313; Anti-Infective Vitamin; Antixerophthalmic Vitamin; Aquasol A; Arovit; Avibon; Avitol; Axerol; Axerophthol; Axerophtholum; Biosterol; Biovit-A; Del-Vi-A; Ido A 50; Idrurto A; Lard Factor; Lard-Factor; Ledovit A; Micelle A; Mulsal A Megadosis; Oleovitamin A; Ophthalamin; Pedi-Vit-A; Retinol, all trans-; Rinocusi Vitaminico; Vitamin A Alcohol; Vitamin A USP; Vitamin A1; Vitaminoftalmina; Vitaminum A; Vogan

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Ohio State University Comprehensive Cancer Center
• Investigators: Principal Investigator: Hannah Choe, MD, Ohio State University Comprehensive Cancer Center

Publications and helpful links

Helpful Links

• The Jamesline

Study record dates

Study Major Dates

• Study Start (Actual): February 7, 2020
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: October 23, 2018
• First Submitted That Met QC Criteria: October 23, 2018
• First Posted (Actual): October 25, 2018

Study Record Updates

• Last Update Posted (Actual): May 12, 2023
• Last Update Submitted That Met QC Criteria: May 10, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Protective Agents; Micronutrients; Antioxidants; Anticarcinogenic Agents; Vitamins; Vitamin A; Retinol palmitate
• Other Study ID Numbers: OSU-18078; NCI-2018-01838 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No