Recruiting
Early Phase 1

Nicotinamide Riboside

Sponsor:

Case Comprehensive Cancer Center

Code:

NCT04332341

Conditions

Allogeneic Hematopoietic Cell Transplantation

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Nicotinamide riboside (NR)

Study Details

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.

Conditions

Allogeneic Hematopoietic Cell Transplantation

Study ID

NCT04332341

Start date

May 19, 2020

Status verified date

Aug, 2026

Completion date

Sep, 2026

Anticipated

Primary completion date

Sep, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Nicotinamide riboside (NR)

Interventions

Nicotinamide riboside (NR)

Nicotinamide riboside, PO, 500mgtwice daily for 21, 28, and 35 days

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Ronald Sobecks, MD

1-866-223-8100TaussigResearch@ccf.org

Locations

Cleveland Clinic, Case Comprehensive Cancer Center

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Navneet Majhail, MD

866-223-8100TaussigResearch@ccf.org

Principal Investigator:

Navneet Majhail, MD

More Information

Sponsor

Case Comprehensive Cancer Center

Last update posted

Aug 6, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Case Comprehensive Cancer Center on 2026-08-06.