ISRCTN12278036进行中（未招募）1 期
A phase Ib study of JNJ-75276617 in combination with AML-directed therapies for participants with acute myeloid leukemia harboring KMT2A or NPM1 alterations
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 150
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Diagnosis of AML according to World Health Organization (WHO) 2016 criteria:
- •1.1. De novo or secondary AML
- •1.2. Relapsed /refractory (Arm A)
- •1.3. Harboring NPM1 / KMT2A alterations
- •2. Pretreatment clinical laboratory values meeting the following criteria -listed below: White blood cell (WBC) count: less than or equal to <=25 x 10^9 per liter (/L), adequate liver and renal function
- •3. ECOG performance status grade of 0, 1 or 2
- •4. A woman of childbearing potential must have a negative highly sensitive serum beta-human chorionic gonadotropin at screening and within 48 hours prior to the first dose of study treatment
- •5. Must sign an informed consent form (ICF) indicating participant understands the purpose of the study and procedures required for the study and is willing to participate in the study.
- •6. Willing and able to adhere to the prohibitions and restrictions specified in this protocol
排除标准
- •1. Acute promyelocytic leukemia according to WHO 2016 criteria
- •2. Leukemic involvement of the central nervous system
- •3. Recipient of solid organ transplant
- •4. Cardiovascular disease that is uncontrolled, increases the risk for Torsades de Pointes or that was diagnosed within 6 months prior to the first dose of study treatment including, but not limited to:
- •4.1. Myocardial infarction
- •4.2. Severe or unstable angina
- •4.3. Clinically significant cardiac arrhythmias, including bradycardia (less than [<] 50 beats per minute)
- •4.4. Uncontrolled (persistent) hypertension: (example, blood pressure greater than [>] 140/90 millimeters of mercury [mm Hg]
- •4.5. Acute neurologic events such as stroke or transient ischemic attack, intracranial or subarachnoid hemorrhage, intracranial trauma
- •4.6. Venous thromboembolic events (for example, pulmonary embolism) within 1 month prior to the first dose of study treatment (uncomplicated Grade less than or equal to [=]2 deep vein thrombosis is not considered exclusionary)
- •4.7. Congestive heart failure (NYHA class III to IV); (h) Pericarditis or clinically significant pericardial effusion
- •4.8. Myocarditis
- •4.9. Endocarditis
- •4.10. Clinically significant hypokalemia, hypomagnesemia, hypocalcemia (corrected for hypoalbuminemia)
- •5. Any toxicity (except for alopecia, stable peripheral neuropathy, thrombocytopenia, neutropenia, anemia) from previous anticancer therapy that has not resolved to baseline or to grade 1 or less
- •6. Pulmonary compromise that requires the need for supplemental oxygen use to maintain adequate oxygenation
研究者
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