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Study on the Efficacy and Safety of VA Regimen Compared to "3+7" Regimen in Newly Diagnosed AML With NPM1 or IDH1/IDH2 Mutations

2026年6月23日 更新者：Shen yang

A Prospective, Multicenter, Randomized Controlled, Open Label, Non-Inferiority Study Comparing the Efficacy and Safety of the VA Regimen (Venetoclax Combined With Azacitidine) With the "3+7" Regimen in the Treatment of Newly Diagnosed AML Patients With NPM1 or IDH1/IDH2 Mutations

This prospective, multicenter, randomized, open-label, non-inferiority clinical study aims to compare the efficacy and safety of VA regimen (venetoclax combined with azacitidine) versus conventional "3+7" chemotherapy regimen in adult patients aged 18 to 65 years with newly diagnosed acute myeloid leukemia (AML) carrying NPM1, IDH1 or IDH2 gene mutations.

The primary goal of this trial is to check whether the VA treatment can reach a non-inferior composite complete remission rate at the end of the induction treatment cycle, which is the key primary endpoint of this research. Several secondary clinical outcomes will also be evaluated in this study, including the rate of minimal residual disease (MRD) negativity after remission, duration of remission, 1-year event-free survival rate and 1-year overall survival rate of enrolled patients. In addition, the safety and treatment-related side effects occurring during the whole induction treatment phase will be systematically collected and compared between two groups as another important secondary assessment.

Eligible enrolled participants will be randomly split into two study groups: patients in experimental group will receive venetoclax plus azacitidine (VA regimen), while patients in control group will receive standard "3+7" induction chemotherapy following conventional clinical protocol. All subjects will complete regular disease assessment, laboratory examinations and scheduled follow-up visits as required by trial design during treatment and post-treatment observation period.

Researchers will collect and analyze all above clinical outcome data from all participants, to verify the non-inferior efficacy and relative safety of VA regimen for this specific subtype of newly diagnosed AML patients.

調査の概要

状態

まだ募集していません

条件

介入・治療

研究の種類

介入

入学 (推定)

148

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

研究場所

  • 中国
    • Shanghai Municipality
      • Shanghai、Shanghai Municipality、中国、200025
        • Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
        • コンタクト：

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:

  • Age ≥ 65 years old ≥ 18 years old;
  • Diagnosed as acute myeloid leukemia (non APL) (diagnostic criteria refer to the 2022 ELN classification system);
  • Initial diagnosis accompanied by NPM1 mutations (A, B, D types and rare types are all acceptable) and/or IDH1/IDH2 mutations;
  • Have not received any other induction therapy before (except hydroxyurea);
  • Physical fitness status score (ECOG PS) 0-3;

  • Having sufficient organ function, defined as follows:

    1. Liver function: serum total bilirubin ≤ 3 x upper limit of normal range (ULN), aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALP) ≤ 3 x ULN, unless considered to be caused by leukemia;
    2. Renal function: endogenous creatinine clearance rate ≥ 30ml/min;
    3. Heart function: NYHA classification ≤ 2 points;
  • Participants must have the ability to understand and be willing to participate in this study, and sign an informed consent form.

Exclusion Criteria:

  • Acute promyelocytic leukemia;
  • Merge extramedullary infiltration such as central nervous system leukemia;
  • Have a clear history of CMML or MDS, and later progress to AML; Or have a history of malignant tumors;
  • There is uncontrolled active infection (including bacterial, fungal, or viral infections);
  • Pregnant or lactating women;
  • Researchers determine that participants are not suitable to participate in this experiment

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：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：Venetoclax plus Azacitidine (VA regimen)
  1. Venetoclax: oral administration, specified dosage and schedule for induction cycle;
  2. Azacitidine: subcutaneous/intravenous injection with standard induction dose and treatment cycle per clinical protocol.
薬：VEN combined with azacitidine
Venetoclax,oral targeted anti-BCL-2 agent and Azacitidine,hypomethylating agent, given via injection for experimental VA arm only
アクティブコンパレータ："3+7" induction chemotherapy
Standard 3+7 induction chemotherapy (Cytarabine continuous infusion for 7 days plus Anthracycline intravenous infusion for 3 days) following routine clinical induction regimen for AML.
薬：Cytarabine plus Daunorubicin
Cytarabine,continuous intravenous infusion for total 7 days and Daunorubicin,Intravenous anthracycline chemotherapy administered for 3 days,in standard 3+7 induction regimen

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
時間枠
Composite complete remission rate at the end of induction cycle
時間枠：At the end of 1-2 induction treatment cycles (each cycle is 28 days)
At the end of 1-2 induction treatment cycles (each cycle is 28 days)

二次結果の測定

結果測定
メジャーの説明
時間枠
Composite Complete Remission
時間枠：At the end of 1-2 induction treatment cycles (each cycle is 28 days)
At the end of 1-2 induction treatment cycles (each cycle is 28 days)
Minimal residual disease (MRD) negative rate after remission
時間枠：At the end of induction cycle (each cycle is 28 days)
At the end of induction cycle (each cycle is 28 days)
Duration of Response (DoR)
時間枠：From date of confirmed complete response (CR) until documented disease relapse or death from any cause, assessed up to 24 months after randomization
From date of confirmed complete response (CR) until documented disease relapse or death from any cause, assessed up to 24 months after randomization
1-year Event-Free Survival (EFS) rate
時間枠：From date of randomization until first documented treatment failure, relapse, or death from any cause, assessed up to 24 months after randomization; 1-year rate calculated at 12 months post-randomization
From date of randomization until first documented treatment failure, relapse, or death from any cause, assessed up to 24 months after randomization; 1-year rate calculated at 12 months post-randomization
1-year Overall Survival (OS) rate
時間枠：From date of randomization until death from any cause, assessed up to 24 months after randomization; 1-year rate calculated at 12 months post-randomization
From date of randomization until death from any cause, assessed up to 24 months after randomization; 1-year rate calculated at 12 months post-randomization
1-year recurrence free survival rate
時間枠：From date of randomization until first confirmed disease recurrence or death from any cause, assessed up to 24 months after randomization; the 1-year rate will be calculated at the 12-month timepoint after randomization
From date of randomization until first confirmed disease recurrence or death from any cause, assessed up to 24 months after randomization; the 1-year rate will be calculated at the 12-month timepoint after randomization
Safety profile during induction therapy
時間枠：From initiation of induction therapy through the end of the induction treatment period,assessed up to 8 weeks after randomization
Evaluate the incidence of grade 3 and grade 4 adverse events classified per CTCAE Version 5.0, the duration of severe adverse events, type, frequency and management of all treatment-emergent adverse events occurring during the induction treatment phase.
From initiation of induction therapy through the end of the induction treatment period,assessed up to 8 weeks after randomization

その他の成果指標

結果測定
時間枠
Correlation between baseline AML gene mutation status detected by next-generation sequencing and anti-leukemic efficacy endpoints (complete remission rate, MRD-negative rate, 1-year recurrence-free survival rate) in VA regimen arm
時間枠：From date of randomization up to 24 months after randomization, biomarker-efficacy correlation analysis will be performed using clinical data collected within the first 12 months post randomization
From date of randomization up to 24 months after randomization, biomarker-efficacy correlation analysis will be performed using clinical data collected within the first 12 months post randomization
Hospitalization duration during induction therapy
時間枠：From the date of induction therapy initiation through completion of the first induction cycle (each cycle is 28 days)
From the date of induction therapy initiation through completion of the first induction cycle (each cycle is 28 days)
Transfusion volume during induction therapy
時間枠：From the date of induction therapy initiation through completion of the first induction cycle (each cycle is 28 days)
From the date of induction therapy initiation through completion of the first induction cycle (each cycle is 28 days)
Medical cost during induction therapy
時間枠：From the date of induction therapy initiation through completion of the first induction cycle (each cycle is 28 days)
From the date of induction therapy initiation through completion of the first induction cycle (each cycle is 28 days)

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。

スポンサー

Shen yang

捜査官

  • 主任研究者：Yang Shen, MD、Ruijin Hospital

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 (推定)

2026年7月1日

一次修了 (推定)

2028年5月31日

研究の完了 (推定)

2032年5月31日

試験登録日

最初に提出

2026年6月10日

QC基準を満たした最初の提出物

2026年6月23日

最初の投稿 (実際)

2026年6月24日

学習記録の更新

投稿された最後の更新 (実際)

2026年6月24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23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

  • NPM1/IDH-AML01

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

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いいえ

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