a Single-arm, Open, Multicenter, Phase II Study to Investigator the Efficacy and Safety of HYML-122 in Patients With FLT3 Positive Relapsed or Refractory Acute Myeloid Leukemia (AML)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- ORR
研究概览
简要总结
this is a single-arm, open, multicenter, phase 2 study to evaluate the efficacy, safety and pharmacokinetics of HYLM-122 monotherapy in Chinese subjects with FLT3 positive relapsed or refractory acute myeloid leukemia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Fully understand the procedures of the clinical study and participate voluntarily with signed and dated written informed consent form, comply with the requirements of the study protocol.
- •Males and/or females at least 18 years old when signing the informed consent form.
- •Histologically confirmed AML (defined using WHO criteria 2016) with one of the following:
- •Refractory to at least 1 cycle of induction chemotherapy. Relapsed after achieving remission with a prior therapy.
- •Subject is positive for FLT3 mutation in bone marrow or blood after completion of the subject's last interventional treatment.
- •Eastern cooperative oncology group performance status (ECOG) ≤2 at screening.
- •Life expectancy of at least 3 months.
- •Women of childbearing potential have a negative pregnancy test at baseline and are willing to employ an effective method of contraception for the entire duration of study treatment and 6 months after the last dose.
排除标准
- •Known or suspected allergies to any of the investigational drug composition (HYML-122, lactose, hydroxypropyl cellulose, hyposubstituted hydroxypropyl cellulose, silicon dioxide, magnesium stearate, titanium dioxide and polyethylene glycol).
- •Medical history and surgical history excluded according to the protocol.
- •Any previous medical treatment history exclude from the protocol.
- •Abnormal laboratory results exclude from the protocol.
- •Combination of treatments and/or drugs required during the study period and cannot be discontinued that excluded from the protocol.
- •Alcohol abuse within 6 months prior to screening, defined as long-term drinking history, generally more than 5 years, equivalent to alcohol quantity ≥40g/d for men, ≥20g/d for women, or heavy drinking history within 2 weeks, equivalent to alcohol quantity ≥80g/d. alcohol volume (g) conversion formula=alcohol consumption (mL)*alcohol content (%)*0.
- •Abortion less than 30 days prior to screening, pregnant and lactating women (currently breast-feeding or less than one year after delivery although not breast-feeding), women of childbearing potential who are not guaranteed effective contraception during the study, planning pregnancy or donating eggs or sperm within 6 months after the last dose.
- •History of drug abuse or drug addicts.
- •Subjects may not be able to complete the study duo to poor compliance or other reasons, or unsuitable for the study by the investigator's judgment.
研究组 & 干预措施
HYML-122 treatment
HYML-122 tablets, 200mg spec, 28 days for each cycle. The first eligible three enrolled subjects will be administrated with 600mg bid dose regimen for 28 consecutive days ( 1 treatment cycle). The Data Monitoring Committee (DMC) will evaluate the safety, efficacy and PK data of these three subjects and make decision whether the regimen need to be adjusted (increasing/decreasing administration dosing or adjusting dosing frequency).
干预措施: HYML-122 (Drug)
结局指标
主要结局
ORR
时间窗: up to 24 months
overall remission rate, including complete remission without minimum residual disease (CRMRD-), complete remission (CR), complete remission with incomplete hematologic recovery (CRi), complete remission without platelet recovery (CRp), partial remission (PR).
composite complete remission (CRc) rate
时间窗: up to 24 months.
CRc rate is defined as the rate of all complete and incomplete remission (CRMRD-+CR+CRp+CRi).
次要结局
- EFS(up to 24 months)
- Cmax,ss(at the end of Cycle 1 (each cycle is 28 days))
- Cmin,ss(at the end of Cycle 1 (each cycle is 28 days))
- RFS(up to 24 months)
- OS(up to 24 months)
- duration of CR remission(up to 24 months)
- AUCss(at the end of Cycle 1 (each cycle is 28 days))
- Incidence of Treatment-Emergent Adverse Events (Safety and tolerability)(up to 24 months)
- Cav,ss(at the end of Cycle 1 (each cycle is 28 days))