이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

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

2026년 6월 1일 업데이트: University of Colorado, Denver

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

연구 개요

상태

모병

정황

개입 / 치료

상세 설명

This is an open label, Phase 2 study for lower risk MDS and high risk CCUS patients who are transfusion independent.

Ten subjects will be accrued in this protocol in two cohorts. The first five subjects in cohort 1 will be given nicotinamide riboside and pterostilbene 250mg-50mg daily for a year. The second cohort will have five subjects and nicotinamide riboside and pterostilbene will be given 250mg-50mg twice daily for a year. The two cohorts can enroll concurrently. Study visits will be every 90 days. Two bone marrow biopsies will be performed, one at the time of screening and one after 180 days of therapy. The bone marrow biopsy at 180 days will serve to assess responses such as changes in variant allele frequencies, as well as correlative studies.

연구 유형

중재적

등록 (추정된)

10

단계

  • 2 단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 장소

  • 미국
    • Colorado
      • Aurora, Colorado, 미국, 80045
        • 모병
        • University of Colorado Hospital
        • 부수사관:
          • Jonathan Gutman, MD
        • 부수사관:
          • Manali Kamdar, MD
        • 부수사관:
          • Daniel Sherbenou, MD
        • 부수사관:
          • Christine McMahon, MD
        • 부수사관:
          • Steven Bair, MD
        • 연락하다:
        • 부수사관:
          • Ajay Major, MD
        • 부수사관:
          • Daniel Pollyea, MD
        • 수석 연구원:
          • Maria Amaya, PhD MD
        • 부수사관:
          • Matthew Angelos, MD
        • 부수사관:
          • Cassandra Duarte, MD
        • 부수사관:
          • Bradley Haverkos, MD
        • 부수사관:
          • Andrew Kent, MD
        • 부수사관:
          • Jorge Monge-Urrea, MD

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위화되지 않음
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Nicotinamide Riboside and Pterostilbene - Low Dose
Participants receive oral nicotinamide riboside 250 mg and pterostilbene 50 mg once daily for up to 12 months.
의약품: Nicotinamide Riboside
Nicotinamide riboside is an orally administered dietary supplement and a vitamin B3 derivative that serves as a precursor to nicotinamide adenine dinucleotide (NAD+).
의약품: Pterostilbene
Pterostilbene is an orally administered dietary supplement and a naturally occurring polyphenol structurally related to resveratrol.
실험적: Nicotinamide Riboside and Pterostilbene - High Dose
Participants receive oral nicotinamide riboside 250 mg and pterostilbene 50 mg twice daily for up to 12 months.
의약품: Nicotinamide Riboside
Nicotinamide riboside is an orally administered dietary supplement and a vitamin B3 derivative that serves as a precursor to nicotinamide adenine dinucleotide (NAD+).
의약품: Pterostilbene
Pterostilbene is an orally administered dietary supplement and a naturally occurring polyphenol structurally related to resveratrol.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Preliminary Efficacy: Cytopenia Improvement
기간: 24 weeks
To assess efficacy of nicotinamide riboside and pterostilbene supplementation by assessing whether it increased hemoglobin by 1g/dL in 24 weeks.
24 weeks

2차 결과 측정

결과 측정
측정값 설명
기간
Safety Information Collection
기간: From enrollment to 30 days after last dose of study drug, approximately 390 days.
To determine the safety of nicotinamide riboside and pterostilbene in patients with CCUS and MDS via AE and SAE collection throughout study. Frequency and proportion of specific AEs will be calculated for the entire cohort, as well as for each individual dosing cohort.
From enrollment to 30 days after last dose of study drug, approximately 390 days.
Additional Efficacy Outcomes - Platelet and Neutrophil Response
기간: From start of study drug to end of treatment, approximately 360 days.
-To assess platelet response and neutrophil response. Platelet response will be defined as an increase of at least 30 x 109/L or an increase from < 20 x 109/L to > 20 x 109/L. Neutrophil response will be defined as an increase of at least 100% and an absolute increase of at least 0.5 x 109/L.
From start of study drug to end of treatment, approximately 360 days.
Additional Efficacy Outcomes - Decrease in Variant Allele Frequency
기간: From start of study drug to end of treatment, approximately 360 days.
-To assess decrease in variant allele frequency by 50%. Secondary end points will include decrease in variant allele frequency by 50%, and platelet and neutrophil response.
From start of study drug to end of treatment, approximately 360 days.

기타 결과 측정

결과 측정
측정값 설명
기간
Patient Survival
기간: From enrollment to end of study, approximately 390 days.
Exploratory efficacy endpoints will include survival. For MDS subjects, progression free survival will be defined as time from MDS diagnosis to progression to AML or death from any cause. Progression free survival for CCUS will be defined as time from CCUS diagnosis to progression to MDS, AML or death from any cause.
From enrollment to end of study, approximately 390 days.

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

University of Colorado, Denver

협력자

Cancer League of Colorado

수사관

  • 수석 연구원: Maria Amaya, PhD MD, University of Colorado, Denver

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2026년 5월 20일

기본 완료 (추정된)

2029년 12월 18일

연구 완료 (추정된)

2030년 12월 18일

연구 등록 날짜

최초 제출

2026년 5월 5일

QC 기준을 충족하는 최초 제출

2026년 5월 5일

처음 게시됨 (실제)

2026년 5월 12일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 6월 3일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 6월 1일

마지막으로 확인됨

2026년 6월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • 25-1665.cc

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

예

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

골수 형성 이상 증후군에 대한 임상 시험

Nicotinamide Riboside에 대한 임상 시험

유사한 임상시험 검색

스폰서 및 공동 작업자

건강 상태

약물 개입

CROs by country

CROs in Qatar

정황

희귀 질병

약물 개입

식이 보충제

스폰서 / 협력자

위치

구독하다