Study of Nicotinamide Riboside Supplementation in Allogeneic Hematopoietic Cell Transplantation
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorCase Comprehensive Cancer Center
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Nicotinamide riboside (NR)
DrugNicotinamide riboside, PO, 500mgtwice daily for 21, 28, and 35 days
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Nicotinamide riboside (NR)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
day +72
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
Time frame
day +143
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
Time frame
day +214
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
Time frame
day +7Secondary outcomes
1
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
Time frame
Up to 100 days from start of treatment2
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.
Time frame
Up to 100 days from start of treatmentSponsors and contacts
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Source ClinicalTrials.gov