RecruitingEarly Phase 1NCT04332341

Study of Nicotinamide Riboside Supplementation in Allogeneic Hematopoietic Cell Transplantation

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


Sponsor

Case Comprehensive Cancer Center

Enrollment

20 participants

Start Date

May 19, 2020

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria4

  • 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 Criteria3

  • 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.

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Interventions

DRUGNicotinamide riboside (NR)

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


Locations(1)

Cleveland Clinic, Case Comprehensive Cancer Center

Cleveland, Ohio, United States

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NCT04332341


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