Research On Nicotinamide Riboside Supplement Support in MDS (ROSS Trial)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Colorado, Denver
About this trial
This is an open-label, phase 2 study for lower risk MDS and high risk CCUS patients who are transfusion independent. There will be two cohorts enrolled at the same time to measure the effect of nicotinamide riboside and pterostilbene at different doses. The primary goals of the study are:
* to assess if study drug improves cytopenias in patients * to determine safety of the study drug in patients
Eligibility criteria
Qualifiers
Subject must voluntarily sign and date an informed consent, approved by an Institutional Review Board (IRB), prior to the initiation of any research directed procedures.
Stated willingness to comply with all study procedures and be available for the duration of the study.
Be a male or female aged ≥ 18 years of age.
For persons of reproductive potential, use of highly effective method(s) of contraception.
Disqualifiers
Subject is known to be positive for HIV with uncontrolled disease. HIV testing is not required.
Subject is known to be positive for hepatitis B or C infection with the exception of those with an undetectable viral load. Hepatitis B or C testing is not required and subjects with serologic evidence of prior vaccination to HBV may participate.
Significant active cardiac disease within the previous 6 months including: New York Heart Association heart failure > class 2, unstable angina, or myocardial infarction.
Renal, neurologic, psychiatric, endocrinologic, metabolic, immunologic, hepatic, cardiovascular disease, or bleeding disorder independent of leukemia.
Trial design
Treatments tested in this trial
- Nicotinamide Riboside
- Pterostilbene
Treatment groups
10 Participants
are divided into 2 treatment groupsSponsors and collaborators
University of Colorado, Denver
Lead sponsor
Cancer League of Colorado
Collaborator
Source ClinicalTrials.gov