Research On Nicotinamide Riboside Supplement Support in MDS (ROSS Trial)

Recruiting now · Phase 2

Conditions studied: Clonal Cytopenia of Undetermined Significance, Myelodysplastic Syndrome

In brief

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

Key facts

Study ID: NCT07579429
Run by: University of Colorado, Denver
People needed: 10
Starts: 2026-05-20
Expected to finish: 2030-12-18
Last updated by the study team: 2026-06-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.
Subject must have confirmation of high risk CCUS (defined by CHRS score) or the diagnosis of MDS in the lower risk category as defined by IPSS-M less than 0.
Patients must have ECOG of ≤ 2
Subject must have adequate renal function as demonstrated by a calculated creatinine clearance ≥ 30 mL/min; determined via urine collection for 24-hour creatinine clearance or by the Cockcroft Gault formula.
Subject must have adequate liver function as demonstrated by:
aspartate aminotransferase (AST) ≤ 3.0 × ULN
alanine aminotransferase (ALT) ≤ 3.0 × ULN
Unless due to Gilbert's syndrome, patients must have a total bilirubin ≤ 3 × ULN.
Subject is informed that consumption of the following fruits is prohibited 3 days prior to the initiation of study treatment and throughout participation: grapefruit, grapefruit products, Seville oranges (including marmalade containing Seville oranges) or Star fruit.

You may not qualify if…

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.
Subject has any history of clinically significant condition(s) that in the opinion of the investigator would adversely affect his/her participating in this study including, but not limited to:
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.
Subject has a malabsorption syndrome or other condition that precludes enteral route of administration. This includes history of inflammatory bowel disease (e.g. Crohn's disease, ulcerative colitis), celiac disease (e.g. sprue), prior gastrectomy or upper bowel removal, or any other gastrointestinal disorder or defect that would interfere with the absorption, distribution, metabolism or excretion of the study drug and/or predispose the subject to an increased risk of gastrointestinal toxicity.
Subject exhibits evidence of uncontrolled systemic infection requiring therapy (viral, bacterial or fungal). Uncontrolled is defined as ongoing signs/symptoms related the infection without improvement despite appropriate antibiotics, antiviral therapy and/or other treatment.
Subject has a history of other malignancies prior to study entry, with the exception of:
Adequately treated in situ carcinoma of the breast or cervix uteri
Basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin
Prostate cancer not requiring therapy beyond hormonal therapy
Previous malignancy confined and surgically resected (or treated with other modalities) with curative intent
Any subject who is transfusion dependent and a candidate for MDS therapy such as erythroid stimulating agents, thrombopoietin receptor agonists, Lusparercept, Imetelstat or hypomethylating agents.
Pregnant or breast-feeding females. A pregnancy test will be obtained at the time of screening if applicable.
Known or suspected hypersensitivity to nicotinamide riboside and pterostilbene.

Where it is running

University of Colorado Hospital — Aurora, Colorado, United States (enrolling)

Full record on ClinicalTrials.gov

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