High Dose Vitamin A for Stem Cell Transplant Recipients

N/A

Recruiting

Led By Hannah Choe, MD

Research Sponsored by Ohio State University Comprehensive Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

* 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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to day 180 after stem cell transplant

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing if high doses of vitamin A can help prevent gastrointestinal GVHD in people undergoing stem cell transplants.

Who is the study for?

This trial is for adults set to have a stem cell transplant from a donor who matches their human leukocyte antigen (HLA) or is slightly mismatched. They should be undergoing this procedure due to blood cancers and can have either intense or less intense pre-transplant treatments.

What is being tested?

The study tests if high doses of vitamin A can prevent gastrointestinal problems after receiving a stem cell transplant from a donor. It's in the early stages, focusing on safety and how well it works to stop these complications.

What are the potential side effects?

Potential side effects are not detailed here, but generally, high doses of vitamin A may cause headaches, dizziness, nausea, skin irritation, pain at the site of injection if given intravenously, and could potentially lead to liver damage with prolonged use.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to day 180 after stem cell transplant

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to day 180 after stem cell transplant

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to day 180 after stem cell transplant for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Vitamin A

Secondary study objectives

Incidence of gastrointestinal graft versus host disease

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Prevention (vitamin A compound)Experimental Treatment1 Intervention

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.

0 / 1Eligibility criteria met