A Phase 2 Study of MAX-40279 Combined With Venetoclax and Azacitidine in Unfit Newly Diagnosed Acute Myeloid Leukemia
調査の概要
詳細な説明
研究の種類
入学 (推定)
段階
- フェーズ2
連絡先と場所
研究連絡先
- 名前：Jing Wang
- 電話番号：8621-61009600
- メール：jwang@maxinovel.com
研究場所
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Tianjin、中国
- 募集
- Institute of Institute of Hematology & Blood Diseases Hospital ( Chinese Academy of Medical Sciences)
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コンタクト：
- jianxiang Wang, MD
- 電話番号：86-22-23909278
- メール：wangjx@ihcams.ac.cn
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参加基準
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
説明
Inclusion Criteria:
1. Patients meeting the World Health Organization (WHO) 2016 diagnostic criteria for newly diagnosed acute myeloid leukemia (AML) patients unfit for intensive chemotherapy:
- Age ≥65 years, or
- Age >18 years and ineligible for standard-dose chemotherapy, defined by ≥1 of the following:
ECOG performance status 2 or 3；History of chronic heart failure (CHF) requiring treatment or left ventricular ejection fraction (LVEF) ≤50% DLCO ≤65% or FEV1 ≤65%Creatinine clearance ≥30 mL/min but ≤45 mL/min (Cockcroft-Gault)、Any other condition deemed incompatible with standard chemotherapy (requires PI approval) 2. No prior AML therapy, except:Hydroxyurea. 3. ECOG performance status ≤3 4. Laboratory requirements: WBC≤3×10*9/L、AST/ALT/ALP ≤3×ULN (except: due to leukemic involvement)、Total bilirubin ≤1.5×ULN、Serum creatinine clearance ≥30 mL/min (measured or calculated) 5. Life expectancy ≥3 months 6. Contraception requirements: Negative pregnancy test for women of childbearing potential；Agreement to use effective contraception during treatment and for 6 months after therapy
Exclusion Criteria:
- AML with BCR::ABL1 fusion、Acute promyelocytic leukemia (APL).
- Secondary AML, including:Therapy-related AML (per WHO classification)、AML with prior history of myelodysplastic syndrome (MDS) or myeloproliferative neoplasm (MPN).
- Use of strong/moderate CYP3A4 inducers within 3 days prior to treatment initiation.
- Hypersensitivity to any study drugs.
- Active malignancy in other organs (requiring treatment).
- Active cardiac disease, defined as ≥1 of the following:Myocardial infarction within 6 months before enrollment；History of symptomatic arrhythmia requiring medication；Uncontrolled/symptomatic congestive heart failure (NYHA Class >2)
- Active infections, including:Untreated tuberculosis or any aspergillosis.
- Known HIV, active hepatitis B (HBV), or hepatitis C (HCV).
- Central nervous system (CNS) leukemia at baseline.
- Conditions limiting oral drug absorption (e.g., malabsorption syndrome).
- Medical history of:Epilepsy requiring medication、Dementia or psychiatric disorders impairing protocol compliance.
- Investigator's discretion for ineligibility.
研究計画
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：なし
- 介入モデル：単一グループの割り当て
- 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 |
|---|---|
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実験的：MAX-40279 Combined with Venetoclax and Azacitidine in unfit newly diagnosed AML
Patients in dose escalation stage received oral MAX-40279 at 40 mg, 50 mg, and 60 mg twice daily (BID), in combination with VEN (100 mg on day 1, 200 mg on day 2, and 400 mg daily thereafter) and AZA (75 mg/m2 days 1-7) in 28-day cycles. Patients in dose expansion stage received RP2D MAX-40279 plus VEN (100 mg on day 1, 200 mg on day 2, and 400 mg daily thereafter) and AZA (75 mg/m2 days 1-7). |
Dose escalation：MAX-40279: 40 mg, 50 mg, and 60 mg twice daily (BID). Dose expantion: MAX-40279 RP2D. Venetoclax: 100 mg on day 1, 200 mg on day 2, and 400 mg daily thereafter. Azacitidine: 75 mg/m2 days 1-7. 28 days are one cycle.
Given by IV, 75 mg/m2
他の名前：
100 mg on day 1, 200 mg on day 2, and 400 mg daily thereafter.
他の名前：
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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 |
|---|---|---|
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DLT
時間枠：Dose escalation; an average of 6 months.
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The dose limiting toxicities, Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
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Dose escalation; an average of 6 months.
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Adverse events (AEs), serious adverse events (SAEs)
時間枠：Through study completion; an average of 24 months.
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Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
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Through study completion; an average of 24 months.
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Maximum Tolerated Dose (MTD) or Recommended Phase 2 Dose (RP2D)
時間枠：Dose escalation; an average of 6 months.
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Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
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Dose escalation; an average of 6 months.
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CRc
時間枠：Through study completion; an average of 24 months.
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complete remission rate
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Through study completion; an average of 24 months.
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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RFS
時間枠：Through study completion; an average of 8 months.
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Recurrence-Free Survival
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Through study completion; an average of 8 months.
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DoR
時間枠：Through study completion; an average of 8 months.
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duration of response
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Through study completion; an average of 8 months.
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OS
時間枠：Through study completion; an average of 24 months.
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overall survival
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Through study completion; an average of 24 months.
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協力者と研究者
スポンサー
捜査官
- 主任研究者：Jianxiang Wang, MD、Institute of Institute of Hematology & Blood Diseases Hospital
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
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
- MAX-40279-010
- CTR20250827 (レジストリ識別子：CENTER FOR DRUG EVALUATION, NMPA)
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
米国FDA規制機器製品の研究
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