Study of Nicotinamide Riboside Supplementation in Allogeneic Hematopoietic Cell Transplantation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Nicotinamide riboside (NR).
- Who it may be relevant to
- Registry conditions: Allogeneic Hematopoietic Cell Transplantation. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Pilot Study of Nicotinamide Riboside Supplementation in Allogeneic Hematopoietic Cell Transplantation
Overview
The purpose of this study is to find a safe and tolerable way to improve engraftment after transplant. Research studies have shown that adding nicotinamide riboside to donor cells has the potential to increase blood stem cell numbers and potentially decrease the time to engraftment. Also, nicotinamide riboside, TRU NIAGEN (the study drug) is a type of vitamin B supplement that the general public can get without a prescription and is well tolerated.
Detailed description
This is a single-center, pilot feasibility study of NR supplementation in allogeneic (donor) HCT in which the study team is seeking to obtain preliminary data on any beneficial effect of increasing NAD+ levels in-vivo to facilitate engraftment. Engraftment is defined as the process during which transplanted stem cells begin to grow in the bone marrow and produce new white blood cells, red blood cells, and platelets. It takes about 14 to 24 days for donor cells to engraft after infusion, and the time between which blood counts fall to the time when they recover is a very critical period. Transfusions are frequently required to prevent bleeding and antibiotics are needed to prevent infections during this critical time period. Shortening the time of engraftment decreases these risks and can improve long-term health status.
The primary objectives of this study is to evaluate safety and tolerability of NR supplementation
The secondary objective of this study is to evaluate neutrophil and platelet recovery after HCT
Interventions
- Drug Nicotinamide riboside (NR)
Nicotinamide riboside, PO, 500mgtwice daily for 21, 28, and 35 days
Primary outcome measures
- Percent of participants who receive >75% of scheduled doses. [Time frame: day +7]
- Percent of participants who receive >75% of scheduled doses. [Time frame: day +14]
- Percent of participants who receive >75% of scheduled doses. [Time frame: day +21]
- Percent of participants experiencing a CTCAE 5.0 grade 3 or higher related to the study drug [Time frame: day +7]
- Percent of participants experiencing a CTCAE 5.0 grade 3 or higher related to the study drug [Time frame: day +14]
- Percent of participants experiencing a CTCAE 5.0 grade 3 or higher related to the study drug [Time frame: day +21]
Secondary outcome measures (2)
- Median days to neutrophil recovery after HCT [Time frame: Up to 100 days from start of treatment]
- Median days to platelet recovery after HCT [Time frame: Up to 100 days from start of treatment]
Eligibility criteria
Inclusion criteria
- All disease indications for allogeneic hematopoietic cell transplantation except for myelofibrosis.
- Subject must meet program eligibility criteria\* for myeloablative conditioning alloHCT and plan to undergo myeloablative conditioning.
- HLA-identical related donor or unrelated human donor source with bone marrow graft.
- Subjects must provide a written informed consent.
Exclusion criteria
- History of allergy or intolerance to NR precursor compounds, including niacin or nicotinamide
- Pregnant or breastfeeding women are excluded from this study since allogeneic HCT is a strict contraindication.
- Subjects with uncontrolled intercurrent illness or psychiatric illness/social situations that would limit compliance with study requirements.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Cleveland Clinic, Case Comprehensive Cancer Center — Cleveland
Identifiers
NCT: NCT04332341 · CASE2Z20