Study of Nicotinamide Riboside Supplementation in Allogeneic Hematopoietic Cell Transplantation

Last updated: April 14, 2025
Sponsor: Case Comprehensive Cancer Center
Overall Status: Active - Recruiting

Phase

1

Condition

Allo-hematopoietic Stem Cell Transplant

Allogeneic Hematopoietic Stem Cell Transplant

Treatment

Nicotinamide riboside (NR)

Clinical Study ID

NCT04332341
CASE2Z20
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • All disease indications for allogeneic hematopoietic cell transplantation except formyelofibrosis.

  • Subject must meet program eligibility criteria* for myeloablative conditioningalloHCT 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

Exclusion Criteria:

  • History of allergy or intolerance to NR precursor compounds, including niacin ornicotinamide

  • Pregnant or breastfeeding women are excluded from this study since allogeneic HCT isa strict contraindication.

  • Subjects with uncontrolled intercurrent illness or psychiatric illness/socialsituations that would limit compliance with study requirements.

Study Design

Total Participants: 20
Treatment Group(s): 1
Primary Treatment: Nicotinamide riboside (NR)
Phase: 1
Study Start date:
May 19, 2020
Estimated Completion Date:
September 30, 2026

Study 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

Connect with a study center

  • Cleveland Clinic, Case Comprehensive Cancer Center

    Cleveland, Ohio 44195
    United States

    Active - Recruiting

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