Allogeneic Hematopoietic Stem Cell Transplantation Recipient
Conditions
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.
Interventions
DIETARY_SUPPLEMENTVitamin A Compound
Given PO or enterally
OTHERBest Practice
Receive usual care
Sponsors
Ohio State University Comprehensive Cancer Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Up to day 28 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of gastrointestinal graft versus host disease | Up to day 180 after stem cell transplant | Cumulative incidence of GI GVHD will be calculated and graphed. |
| Incidence of Toxicity | Up to 28 days | The toxicity analysis will include summarization of the toxicity and tolerability will be tabulated by dose level and summarized. Severe (grade 3+) toxicities will be summarized as well by type as well as in summary format of hematologic vs. non-hematologic severe toxicity incidence. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORHannah Choe, MD
Ohio State University Comprehensive Cancer Center
Outcome results
None listed