Research On Nicotinamide Riboside Supplement Support in MDS (ROSS Trial) (ROSS)
2026年6月1日 更新者：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
調査の概要
詳細な説明
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.
研究の種類
介入
入学 (推定)
10
段階
- フェーズ2
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Derek Schatz
- 電話番号：720-848-0628
- メール：derek.schatz@cuanschutz.edu
研究場所
-
-
Colorado
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Aurora、Colorado、アメリカ、80045
- 募集
- University Of Colorado Hospital
-
副調査官：
- Jonathan Gutman, MD
-
副調査官：
- Manali Kamdar, MD
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副調査官：
- Daniel Sherbenou, MD
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副調査官：
- Christine McMahon, MD
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副調査官：
- Steven Bair, MD
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コンタクト：
- Derek Schatz
- 電話番号：(720) 848-0628
- メール：DEREK.SCHATZ@CUANSCHUTZ.EDU
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副調査官：
- Ajay Major, MD
-
副調査官：
- Daniel Pollyea, MD
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主任研究者：
- Maria Amaya, PhD MD
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副調査官：
- Matthew Angelos, MD
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副調査官：
- Cassandra Duarte, MD
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副調査官：
- Bradley Haverkos, MD
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副調査官：
- Andrew Kent, MD
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副調査官：
- Jorge Monge-Urrea, MD
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：非ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Nicotinamide Riboside and Pterostilbene - Low Dose
Participants receive oral nicotinamide riboside 250 mg and pterostilbene 50 mg once daily for up to 12 months.
|
Nicotinamide riboside is an orally administered dietary supplement and a vitamin B3 derivative that serves as a precursor to nicotinamide adenine dinucleotide (NAD+).
Pterostilbene is an orally administered dietary supplement and a naturally occurring polyphenol structurally related to resveratrol.
|
|
実験的：Nicotinamide Riboside and Pterostilbene - High Dose
Participants receive oral nicotinamide riboside 250 mg and pterostilbene 50 mg twice daily for up to 12 months.
|
Nicotinamide riboside is an orally administered dietary supplement and a vitamin B3 derivative that serves as a precursor to nicotinamide adenine dinucleotide (NAD+).
Pterostilbene is an orally administered dietary supplement and a naturally occurring polyphenol structurally related to resveratrol.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Preliminary Efficacy: Cytopenia Improvement
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Safety Information Collection
時間枠：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
時間枠：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.
|
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Additional Efficacy Outcomes - Decrease in Variant Allele Frequency
時間枠：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.
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Patient Survival
時間枠：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.
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From enrollment to end of study, approximately 390 days.
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：Maria Amaya, PhD MD、University of Colorado, Denver
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2026年5月20日
一次修了 (推定)
2029年12月18日
研究の完了 (推定)
2030年12月18日
試験登録日
最初に提出
2026年5月5日
QC基準を満たした最初の提出物
2026年5月5日
最初の投稿 (実際)
2026年5月12日
学習記録の更新
投稿された最後の更新 (実際)
2026年6月3日
QC基準を満たした最後の更新が送信されました
2026年6月1日
最終確認日
2026年6月1日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- 25-1665.cc
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
はい
米国FDA規制機器製品の研究
いいえ
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。