jRCT2080225162已完成2 期
A Phase I/II, Multicenter, Open-Label, Nonrandomized Study to Evaluate the Tolerability and Safety of ASTX660 and the Efficacy at the Recommended Dose of ASTX660 in Patients With Relapsed or Refractory T-Cell Lymphoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 1
- 主要终点
- Dose Limiting Toxicity
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 干预模型
- Multicenter, Open-label, Nonrandomized, Phase 1/2 Trial
- 主要目的
- Treatment Purpose
入排标准
- 年龄范围
- 20age old over 至 No limit（—）
- 性别
- All
入选标准
- •Patients with T-cell lymphoma with histological diagnosis based on WHO classification (2017)
- •Patients with evaluable lesions.
- •Patients with ECOG PS score of 0 or
- •Patients with adequate organ functions as shown below.
- •a) AST and ALT 2.0xULN or less (3.0xULN or less if liver infiltration is present)
- •b) Total bilirubin 1.5xULN or less
- •c) ANC 1,000/mm3 or more (750/mm3 or more if bone marrow infiltration is present)
- •d) Platelet count 50,000/mm3 or more (25,000/mm3 or more if bone marrow infiltration is present)
- •e) Serum creatinine 1.5xULN or less or creatinine clearance 50 mL/min or more
- •f) Amylase and lipase 1.0xULN or less
排除标准
- •Patients with active infection requiring treatment with antibiotics, antifungals, or antivirals
- •Patients with heart disease that meets the followings:
- •a) LVEF of < 50% by echocardiography or MUGA scan
- •b) Congestive heart failure (NYHA classification 3 or 4)
- •c) Uncontrolled heart disease including unstable angina pectoris or hypertension considered to require hospitalization within last 3 months (90 days)
- •d) Complete left bundle branch block, 3 degree (complete) atrioventricular block, use of pacemaker, history or complication of poorly controlled arrhythmia requiring treatment
- •e) History or complication of long QT syndrome
- •f) History or complication of ventricular arrhythmia requiring active treatment
- •g) Corrected QT interval of 470 or more msec based on 12-lead ECG performed at the screening
- •h) Concern on increased cardiac risk by participating in the study based on medical judgment
- •Patients receiving the following treatment for the primary disease prior to the initial dose of study drug
- •a) Chemotherapy or radiotherapy within last 3 weeks
- •b) Skin directed therapy including local treatment or phototherapy within last 3 weeks
- •c) Treatment with monoclonal antibody within last 4 weeks
- •d) Treatment with other study drugs or study treatment within last 3 weeks or 5 half-lives, whichever is longer
- •Patients with prior allogeneic stem cell transplantation, or autologous stem cell transplantation within 14 weeks prior to the day of initial dose of study drug
- •Patients who have received corticosteroids at a dose exceeding a prednisone equivalent dose of 10 mg/day within 3 weeks prior to the initial dose of study drug.
- •Patients with Inadequately controlled diabetes mellitus
结局指标
主要结局
Dose Limiting Toxicity
Phase I part(dose-escalation part)
Safety
Phase I part(ATLL expansion part)
Overall response rate(ORR)
Phase II part: by the Central Data Review Committee
次要结局
未报告次要终点
研究者
研究点 (1)
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