NCT06220162招募中2 期
A Clinical Study of Chidamide in Combination With Venetoclax and Azacitidine (VAC) for Patients With Acute Myeloid Leukemia Who Did Not Achieve CR/CRi/MLFS (PR or NR) With One Cycle of Venetoclax and Azacitidine (VA).
The First Affiliated Hospital of Soochow University1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2024年2月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- ORR(overall response rate)
研究概览
简要总结
Chidamide in combination with venetoclax and azacitidine (VAC) were expected to improve remission rate of patients following to VA regimen treatment failure.
详细描述
Venetoclax and azacitidine has become the standard first-line treatment for elderly/unsuitable AML patients who can't tolerate for intense chemotherapy.
However, a proportion of patients who were not able to achieve remission after failing to VA regimen and then were given the second cycle, and their rate of achieving remission was even lower. Chidamide down-regulates the expression of MCL and is expected to improve the remission rate further in combination with VA regimen.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with AML who are not suitable for intensive chemotherapy according to the WHO diagnosis: age ≥60 years or age <60 years but fulfil the following criteria;
- •Age 18 to 59 years;
- •Eastern Cooperative Oncology Group (ECOG) physical status score of 2 or 3;
- •Expected survival time ≥3 months;
- •Or fulfilment of severe cardiac, pulmonary, hepatic, or renal disease; (A) Presence of a cardiac history of congestive heart failure, or ejection fraction ≤ 50%, or presence of chronic stable angina; (B) Lung carbon monoxide diffusing capacity (DLCO) ≤ 65%, or first forced expiratory volume (FEV1) ≤ 65%; (C) Moderate hepatic impairment with total bilirubin > 1.5 to ≤ 3.0 x upper limit of normal (ULN); (D) Creatinine clearance ≥ 30 mL/min to < 45 mL/min;
- •Not received radiotherapy, treatment regimens other than the VA regimen, or haematopoietic stem cell transplantation within 4 weeks prior to enrolment;
- •Other comorbidities that, in the judgement of the physician, make the administration of intensive chemotherapy unsuitable;
- •Ability to understand and willingness to sign the informed consent for this trial;
- •The patient refuses intensive chemotherapy and has the willingness to accept non-intensive chemotherapy.
排除标准
- •Patients with a history of myeloproliferative neoplasms (MPN), including myelofibrosis, thrombocythemia, polycythaemia vera, chronic granulocytic leukemia (CML) with or without BCR-ABL1 translocation, and AML or acute promyelocytic leukemia (APL) with BCR-ABL1 translocation;
- •Patients with FLT3 mutations and who were treated with targeted agents (inclusion is possible if the use of specific targeted agents is discontinued);
- •Patients with less than 50% reduction of blasts after VA regimen;
- •Patients with active CNS involvement;
- •With prior treatment with chidamide;
- •Clinically uncontrolled active infections (including bacterial, fungal or viral infections) and organ hemorrhage;
- •Pregnant or lactating women;
- •Participation in any other clinical trial within 3 months prior to VAC regimen;
- •With other malignant tumours;
- •With uncontrolled mental disorders;
- •Any other condition that, in the opinion of the investigator, makes it inappropriate to participate in this trial.
研究组 & 干预措施
VAC regimen
Experimental
干预措施: chidamide in combination with venetoclax and azacitidine (VAC) (Drug)
结局指标
主要结局
ORR(overall response rate)
时间窗: 1 month
ORR was calculated as the sum of CR, CRi, MLFS and PR.
次要结局
- Adverse events (AEs)(2 months)
- EFS (Event-free survival)(2 years)
- OS (Overall survival)(2 years)
研究者
Sheng-Li Xue, MD
Prof.
The First Affiliated Hospital of Soochow University
研究点 (1)
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