Clinical trial NCT04332341: Study of Nicotinamide Riboside Supplementation in Allogeneic Hematopoietic Cell Transplantation
Official title: A Pilot Study of Nicotinamide Riboside Supplementation in Allogeneic Hematopoietic Cell Transplantation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Allogeneic Hematopoietic Cell Transplantation
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2020-04-02
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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

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.

Primary outcomes:
measure: Percent of participants who receive >75% of scheduled doses.
timeFrame: day +7
measure: Percent of participants who receive >75% of scheduled doses.
timeFrame: day +14
measure: Percent of participants who receive >75% of scheduled doses.
timeFrame: day +21
measure: Percent of participants experiencing a CTCAE 5.0 grade 3 or higher related to the study drug
timeFrame: day +7
measure: Percent of participants experiencing a CTCAE 5.0 grade 3 or higher related to the study drug
timeFrame: day +14
measure: Percent of participants experiencing a CTCAE 5.0 grade 3 or higher related to the study drug
timeFrame: day +21
Secondary outcomes:
measure: Median days to neutrophil recovery after HCT
timeFrame: Up to 100 days from start of treatment
measure: Median days to platelet recovery after HCT
timeFrame: Up to 100 days from start of treatment
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic, Case Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Cleveland Clinic, Case Comprehensive Cancer Center
name: Ronald Sobecks, MD
role: PRINCIPAL_INVESTIGATOR
References: