2024-520154-38-00招募中3 期
A Phase 3 Randomized, Double-blind, Placebo-controlled, Study of Bleximenib, Venetoclax and Azacitidine for the Treatment of Participants with Newly Diagnosed Acute Myeloid Leukemia Harboring KMT2ARearrangements or NPM1Mutations who are Ineligible for Intensive Chemotherapy
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 246
- 试验地点
- 104
- 主要终点
- Dual primary endpoints: CR and OS
研究概览
简要总结
To compare the efficacy of bleximenib and VEN+AZA vs VEN+AZA alone
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Be ≥18 years of age (or the legal age of majority in the jurisdiction in which the study is taking place, whichever is greater) at the time of informed consent.
- •Previously untreated KMT2Ar or NPM1m AML with ≥10% blasts per 2022 ICC criteria. -Participants with KMT2A partial tandem duplications or amplifications are NOT eligible. -Emergency leukapheresis or cytoreductive therapy with hydroxyurea or 1 dose up to 2 g/m2 cytarabine is permitted prior to first dose of study treatment. Note: these treatments should not be given until after the screening bone marrow assessment. Leukapheresis and cytarabine must be discontinued ≥24 hours prior to first dose of study treatment.
- •Ineligible for intensive chemotherapy based on the following criteria: ≥75 years of age and ineligible per physician’s discretion, with ECOG performance status of 0-2 ≥18 to <75 years of age with ≥1 of the following comorbidities: ECOG performance status of 2 Severe cardiac disorder (eg, congestive heart failure requiring treatment or chronic stable angina) Severe pulmonary disorder (eg, DLCO ≤ 65% or FEV1 ≤65%) Renal impairment defined as eGFR (MDRD formula) Comorbidity that, in the investigator’s opinion, makes the participant unsuitable for intensive chemotherapy, which must be documented before enrollment. Ineligibility for intensive chemotherapy should be explicitly approved by a multidisciplinary team in countries in which this process is standard of care
- •Adequate renal and hepatic functions prior to randomization: AST and ALT <3 × ULN; for participants with leukemic organ involvement (documented by biopsy or imaging) AST and ALT <5 × ULN is permitted. Total bilirubin ≤1.5 × ULN, unless bilirubin rise is due to congenital nonhemolytic hyperbilirubinemia such as Gilbert’s syndrome or of non-hepatic origin. eGFR (MDRD formula)
- •WBC count < 25 X 10^9/ L
排除标准
- •Known active leukemic involvement of the CNS
- •History of myelofibrosis
- •Cardiac disease: a. Any of the following within 6 months of randomization: myocardial infarction, uncontrolled/unstable angina, congestive heart failure (NYHA Class III or IV uncontrolled or symptomatic arrhythmias, stroke, or transient ischemic attack. b. QTcF ≥450 msec for males and ≥470 msec for females. Participants with a family history of Long QT syndrome are excluded. For participants with documented wide QRS interval (eg, due to a bundle branch block), alternate methods of calculating a corrected QT interval may be appropriate for eligibility determination if recommended by a consulting cardiologist and approved by the sponsor, provided there is no evidence or history of a repolarization abnormality.
- •Chronic respiratory disease requiring oxygen
- •Active infection that is uncontrolled prior to first dose of study treatment and may interfere with the study objectives or expose the patient to undue risk by participating in the trial; an infection controlled with systemic therapy is allowed.
结局指标
主要结局
Dual primary endpoints: CR and OS
Dual primary endpoints: CR and OS
次要结局
未报告次要终点
研究者
CTIS Point of Contact
Scientific
Janssen Cilag International
研究点 (104)
Loading locations...
相似试验
尚未招募
2 期
PreVent-ACaLLChronic Lymphocytic Leukemia2024-511072-33-00Rigshospitalet50
招募中
3 期
Zimberelimab and Domvanalimab in Combination With Chemotherapy Versus Pembrolizumab With Chemotherapy in Patients With Untreated Metastatic Non–Small Cell Lung Cancer.2023-509825-38-00Gilead Sciences Inc.322
招募中
2 期
Study of axitinib +/- pembrolizumab in first line treatment for patients with locally advanced or metastatic papillary renal cell carcinoma (PRCC)2024-513986-38-00Centre Leon Berard72
招募中
3 期
Multicenter, Phase 3 Study of Venetoclax and Azacitidine as Maintenance Therapy for Patients with Acute Myeloid Leukemia in First Remission After Conventional Chemotherapy2023-507221-42-00AbbVie Deutschland GmbH & Co. KG41
招募中
3 期
Study Evaluating Zipalertinib with Chemotherapy for Lung Cancer Patients with Uncommon EGFR Mutations After Surgery2025-521775-31-00Taiho Oncology Inc.91