Nicotinamide Riboside Supplementation in Allogeneic Hematopoietic Cell Transplantation

This study is testing if Nicotinamide riboside (TRU NIAGEN), a type of vitamin B supplement, can safely and effectively improve how well new blood cells grow after an allogeneic hematopoietic cell transplant (a transplant using donor cells). Researchers believe that adding Nicotinamide riboside might help increase the number of blood stem cells and speed up the time it takes for them to engraft (start growing in your bone marrow). This could reduce risks like bleeding and infections. The study is looking at how many participants can take most of their scheduled doses. You may be able to join if you are 18 or older, having an allogeneic hematopoietic cell transplant for most conditions (except myelofibrosis), and meet other transplant criteria. The current status of this study is unclear.

Study design
This is a single-center pilot study with a planned enrollment of 20 participants. It is testing Nicotinamide riboside.
What's involved
You would take Nicotinamide riboside by mouth twice daily for 21, 28, or 35 days. The study will check how much of the medication you take over 7, 14, and 21 days.
Compensation
Not stated in the trial record.
Follow-up
The primary goals of the study are measured at day +7, day +14, and day +21 after the transplant.

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NCT04332341

Study of Nicotinamide Riboside Supplementation in Allogeneic Hematopoietic Cell Transplantation

Recruiting
EARLY_PHASE1Ages 18+InterventionalTreatment
Case Comprehensive Cancer Center
~20 participants
Updated 2026-08-06 on ClinicalTrials.gov
What's tested:Nicotinamide riboside (NR)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percent of participants who receive >75% of scheduled doses.
Measured over day +7
+5 more outcomes measured
Allogeneic Hematopoietic Cell Transplantation
1 sites across 1 states
Ohio1
  • Ronald Sobecks, MD · PRINCIPAL_INVESTIGATOR · Cleveland Clinic, Case Comprehensive Cancer Center

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Eligibility criteria

Inclusion

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

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.
  • Percent of participants who receive >75% of scheduled doses.day +7

    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

  • Percent of participants who receive >75% of scheduled doses.day +14

    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

  • Percent of participants who receive >75% of scheduled doses.day +21

    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

  • Percent of participants experiencing a CTCAE 5.0 grade 3 or higher related to the study drugday +7

    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

  • Percent of participants experiencing a CTCAE 5.0 grade 3 or higher related to the study drugday +14

    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

  • Percent of participants experiencing a CTCAE 5.0 grade 3 or higher related to the study drugday +21

    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