Study of Nicotinamide Riboside Supplementation in Allogeneic Hematopoietic Cell Transplantation

Allogeneic Hematopoietic Cell Transplantation Clinical Trial

Official title:

A Pilot Study of Nicotinamide Riboside Supplementation in Allogeneic Hematopoietic Cell Transplantation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04332341
• Other study ID #: CASE2Z20
• Status: Recruiting
• Phase: Early Phase 1
• Start date: May 19, 2020
• Est. completion date: March 1, 2025

Study information

• Verified date: June 2024
• Source: Case Comprehensive Cancer Center
• Contact: Ronald Sobecks, MD
• Phone: 1-866-223-8100
• Email: TaussigResearch[@]ccf.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: March 1, 2025
• Est. primary completion date: October 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Allogeneic Hematopoietic Cell Transplantation

Intervention

Drug:
• Nicotinamide riboside (NR)
Nicotinamide riboside, PO, 500mgtwice daily for 21, 28, and 35 days

Locations

Country	Name	City	State
United States	Cleveland Clinic, Case Comprehensive Cancer Center	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Case Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent of participants who receive >75% of scheduled doses.	Tolerability of NR in allogeneic HCT recipients, defined as 8 or more of 15 participants (i.e. at least 50% of enrolled subjects) able to receive >75% of their scheduled doses (overall rate 53%, 95% confidence intervals 33%-86%). This will include both patients who discontinue NR due to study drug related toxicity and patients who are not able to stay on NR due to transplant related toxicity that limits ability to take the drug	day +7
Primary	Percent of participants who receive >75% of scheduled doses.	Tolerability of NR in allogeneic HCT recipients, defined as 8 or more of 15 participants (i.e. at least 50% of enrolled subjects) able to receive >75% of their scheduled doses (overall rate 53%, 95% confidence intervals 33%-86%). This will include both patients who discontinue NR due to study drug related toxicity and patients who are not able to stay on NR due to transplant related toxicity that limits ability to take the drug	day +14
Primary	Percent of participants who receive >75% of scheduled doses.	Tolerability of NR in allogeneic HCT recipients, defined as 8 or more of 15 participants (i.e. at least 50% of enrolled subjects) able to receive >75% of their scheduled doses (overall rate 53%, 95% confidence intervals 33%-86%). This will include both patients who discontinue NR due to study drug related toxicity and patients who are not able to stay on NR due to transplant related toxicity that limits ability to take the drug	day +21
Primary	Percent of participants experiencing a CTCAE 5.0 grade 3 or higher related to the study drug	Safety of NR in allogeneic HCT recipients as measured by percent of participants experiencing a CTCAE 5.0 grade 3 or higher that is related to the study drug	day +7
Primary	Percent of participants experiencing a CTCAE 5.0 grade 3 or higher related to the study drug	Safety of NR in allogeneic HCT recipients as measured by percent of participants experiencing a CTCAE 5.0 grade 3 or higher that is related to the study drug	day +14
Primary	Percent of participants experiencing a CTCAE 5.0 grade 3 or higher related to the study drug	Safety of NR in allogeneic HCT recipients as measured by percent of participants experiencing a CTCAE 5.0 grade 3 or higher that is related to the study drug	day +21
Secondary	Median days to neutrophil recovery after HCT	Median and range of days to neutrophil recovery after HCT. Recovery defined as first day of three consecutive days with absolute neutrophil count 500 cells/mm3 (0.5 x 109/L) or greater	Up to 100 days from start of treatment
Secondary	Median days to platelet recovery after HCT	Median and range of days to Platelet recovery after HCT. Recovery defined as first day of three consecutive days with platelet count 20,000/mm3 (20 x 109/L) or greater and unsupported by platelet transfusions.	Up to 100 days from start of treatment