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Study of Nicotinamide Riboside Supplementation in Allogeneic Hematopoietic Cell Transplantation

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ClinicalTrials.gov Identifier: NCT04332341
Recruitment Status : Suspended (COVID-19 hold)
First Posted : April 2, 2020
Last Update Posted : August 25, 2020
Sponsor:
Information provided by (Responsible Party):
Case Comprehensive Cancer Center

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.

Condition or disease Intervention/treatment Phase
Allogeneic Hematopoietic Cell Transplantation Drug: Nicotinamide riboside (NR) Early Phase 1

Detailed 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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study of Nicotinamide Riboside Supplementation in Allogeneic Hematopoietic Cell Transplantation
Actual Study Start Date : May 19, 2020
Estimated Primary Completion Date : March 1, 2022
Estimated Study Completion Date : March 1, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Nicotinamide riboside (NR) Drug: Nicotinamide riboside (NR)
Nicotinamide riboside, PO, 500mgtwice daily for 21, 28, and 35 days




Primary Outcome Measures :
  1. Percent of participants who receive >75% of scheduled doses. [ Time Frame: 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

  2. Percent of participants who receive >75% of scheduled doses. [ Time Frame: 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

  3. Percent of participants who receive >75% of scheduled doses. [ Time Frame: 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

  4. Percent of participants experiencing a CTCAE 5.0 grade 3 or higher related to the study drug [ Time Frame: day +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

  5. Percent of participants experiencing a CTCAE 5.0 grade 3 or higher related to the study drug [ Time Frame: day +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

  6. Percent of participants experiencing a CTCAE 5.0 grade 3 or higher related to the study drug [ Time Frame: day +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


Secondary Outcome Measures :
  1. Median days to neutrophil recovery after HCT [ Time Frame: Up to 100 days from start of treatment ]
    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

  2. Median days to platelet recovery after HCT [ Time Frame: Up to 100 days from start of treatment ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04332341


Locations
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United States, Ohio
Cleveland Clinic, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
Case Comprehensive Cancer Center
Investigators
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Principal Investigator: Navneet Majhail, MD Cleveland Clinic, Case Comprehensive Cancer Center
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Responsible Party: Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT04332341    
Other Study ID Numbers: CASE2Z20
First Posted: April 2, 2020    Key Record Dates
Last Update Posted: August 25, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: IPD will not be shared publicly

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Niacinamide
Niacin
Nicotinic Acids
Vitamin B Complex
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Vasodilator Agents