Clinical trial NCT03719092: High Dose Vitamin a in Preventing Gastrointestinal GVHD in Participants Undergoing Donor Stem Cell Transplant
Official title: Single, High Dose Vitamin a Replacement in Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplantation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Allogeneic Hematopoietic Stem Cell Transplantation Recipient
Lead sponsor: Ohio State University Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2018-10-25
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

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

Primary outcomes:
measure: 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
timeFrame: Up to day 28
Secondary outcomes:
measure: Incidence of gastrointestinal graft versus host disease
timeFrame: Up to day 180 after stem cell transplant
measure: Incidence of Toxicity
timeFrame: Up to 28 days
Other outcomes:
measure: Compliance of Stool collection
timeFrame: Pre-transplant, day 0, day 14, and day 28
measure: Stool microbe and vitamin A correlation
timeFrame: Pre-transplant, day 0, day 14, and day 28
Locations:
city: Columbus
country: United States
facility: Ohio State University Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Ohio State University Comprehensive Cancer Center
name: Hannah Choe, MD
role: PRINCIPAL_INVESTIGATOR
References: