High Dose Vitamin A in Preventing Gastrointestinal GVHD in Participants Undergoing Donor Stem Cell Transplant
| Status: | Not yet recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 10/27/2018 |
| Start Date: | December 1, 2018 |
| End Date: | December 31, 2021 |
| Contact: | Ohio State University Comprehensive Cancer Center |
| Email: | OSUCCCClinicaltrials@osumc.edu |
| Phone: | 800-293-5066 |
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.
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 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.
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.
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
We found this trial at
1
site
Columbus, Ohio 43210
Principal Investigator: Hannah Choe, MD
Phone: 614-293-5428
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