JPRN-jRCT2031210152
暂停
1 期
A Phase 1 First-In-Human Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of AMG 427 in Subjects With Relapsed/Refractory Acute Myeloid Leukemia.
ocal Contact0 个研究点目标入组 200 人2021年6月15日
概览
- 阶段
- 1 期
- 干预措施
- 未指定
- 疾病 / 适应症
- Relapsed/Refractory Acute Myeloid Leukemia (AML)
- 发起方
- ocal Contact
- 入组人数
- 200
- 状态
- 暂停
- 最后更新
- 2年前
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •1\. Subject has provided informed consent prior to initiation of any study\-specific activities/procedures.
- •2\. Subjects greater than or equal to 18 years of age at the time of signing consent.
- •3\. For relapsed/refractory AML subjects only, AML as defined by the WHO Classification as persisting or recurring following 1 or more treatment courses (exceptions noted in exclusion criteria).
- •4\. Myeloblasts greater than or equal to 5% in bone marrow, as confirmed by immunophenotype by flow cytometry.
- •5\. Eastern Cooperative Oncology Group (ECOG) Performance Status of less than or equal to 2\.
- •6\. Renal function as follows: serum creatinine less than 2\.0 mg/dL (176\.84 mol/L); estimated glomerular filtration rate (eGFR) greater than 30 mL/min/1\.73 m2\.
- •7\. Hepatic function as follows: aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than or equal to 3\.0 x upper limit of normal (ULN); bilirubin less than or equal to 1\.5 x ULN (unless considered due to Gilbert's syndrome or hemolysis).
- •8\. No active tuberculosis in the setting of anti\-TNF therapy \- National guidelines should be followed for the appropriate tuberculosis screening in the setting of anti\-TNF therapy, including a minimum of:
- •\- Subject has a negative test for tuberculosis during screening defined as either:
- •\-\- Negative purified protein derivative (PPD) (\< 5 mm induration at 48 to 72 hours after test is placed) OR
排除标准
- •1\. Patients with acute promyelocytic leukemia (APML).
- •2\. Active extramedullary AML in the central nervous system (CNS)
- •3\. Known hypersensitivity to immunoglobulins.
- •4\. White blood cells (WBC) greater than 15,000 cells/mcL (15 cells x 10^9/L) at screening (hydroxyurea is permitted to enable eligibility).
- •5\. Subjects with a prior or concurrent malignancy whose natural history or treatment is anticipated to interfere with the safety or efficacy assessment of the investigational regimen. Exception: Subjects with prior or concurrent malignancy not anticipated to interfere with the safety or efficacy of the investigational regimen may be included only after discussion with the Amgen Medical Monitor.
- •6\. Autologous HSCT within 6 weeks prior to start of AMG 427 treatment.
- •7\. Allogeneic HSCT within 3 months prior to start of AMG 427 treatment.
- •8\. Any graft\-versus\-host disease requiring systemic therapy with immunomodulators.
- •9\. History or evidence of significant cardiovascular risk including any of the following: symptomatic congestive heart failure, unstable angina, clinically significant arrhythmias (eg, ventricular fibrillation, ventricular tachycardia etc.), recent coronary angioplasty, intra\-cardiac defibrillators or any clinically relevant concurrent disorder that may pose a risk to subject safety or interfere with study evaluation, procedures, or completion.
- •10\. History of arterial thrombosis (eg, stroke or transient ischemic attack) in the past 3 months.
结局指标
主要结局
未指定
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