EUCTR2022-001279-15-ES进行中（未招募）1 期
A Phase 1b/2 study of the safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of the selective SYK inhibitor lanraplenib (LANRA) in combination with the FLT3 inhibitor gilteritinib, in patients with FLT3-mutated relapsed or refractory AML - Lanraplenib plus gilteritinib therapy in patients with FLT3 mutated, R/R AM
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 55
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Adults =18 years of age with acute myeloid leukemia (AML) and at least 1 prior line of therapy
- •- FLT3-mutated disease documented in a local reference laboratory
- •- Have the ability to understand the requirements and procedures of the study and sign a written informed consent form
- •- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1 or 2
- •- Adequate hepatic and renal function
- •- Prothrombin time (PT), activated partial thromboplastin time (aPTT) and international normalized ratio (INR) =1.5x upper limit of normal (ULN) unless receiving therapeutic anticoagulation
- •- Negative serum ß-human chorionic gonadotropin (HCG) test in women of child-bearing potential (WOCBP)
- •- Left ventricular ejection fraction =50% confirmed by echocardiogram (ECHO) or multi-gated acquisition (MUGA) scan
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 45
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •- Known central nervous system (CNS) involvement with leukemia
- •- Clinical signs/symptoms of leukostasis that have failed therapy including hydroxyurea and/or leukapheresis of at least 3 days duration
- •- Pregnant or breastfeeding women
- •- Active infection with hepatitis B, C or human immunodeficiency virus (HIV) infection
- •- Disseminated intravascular coagulation with active bleeding or signs of thrombosis
- •- Known active COVID-19
- •- Administration of a live attenuated virus vaccine within 35 days before Cycle 1 Day 1 (C1D1)
- •- History of non-myeloid malignancy except for the following: adequately treated localized basal cell or squamous cell carcinoma of the skin; cervical carcinoma in situ; superficial bladder cancer; asymptomatic prostate cancer without known metastatic disease, with no requirement for therapy or requiring only hormonal therapy and with normal prostate specific antigen for > 1 year prior to start of study therapy; or any other cancer that has been in complete remission without treatment for =3 years prior to enrollment
- •- Clinically significant heart disease
- •- Patients with a corrected QT interval (using the Fridericia formula, QTcF) >480 msec or Long QT Syndrome
- •- Evidence of ongoing uncontrolled systemic bacterial, fungal, or viral infection at the time of study treatment initiation
- •- Current (within 30 days of study enrollment) drug-induced liver injury, chronic active hepatitis, alcoholic liver disease, nonalcoholic steatohepatitis, primary biliary cholangitis with inadequate response to ursodeoxycholic acid or other health authority approved therapy , extrahepatic obstruction caused by cholelithiasis, cirrhosis of the liver, or portal hypertension
- •- Ongoing (within 6 weeks of study enrollment) hepatic encephalopathy
- •- Ongoing immunosuppressive therapy, including systemic chemotherapy for treatment of leukemia
- •- Subject requiring chronic treatment with strong cytochrome P450 (CYP) 3A4 inhibitors or inducers beginning 7 days prior to initiating study treatment until study treatment completion
研究者
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