NCT04722952Unknown3 期
an Single Center，Single Arm, Phase 3 Study to Evaluate Efficacy and Safety of PD-1 Inhibitor Combined With Azacytidine and HAG Regimen for Patients With Relapsed or Refractory Acute Myeloid Leukemia.
The First Affiliated Hospital of Soochow University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2021年5月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Complete remission， Incomplete blood count recovery，Partial remission（CR+CRi+PR）
研究概览
简要总结
This is an single center, single arm, phase 3 study to evaluate efficacy and safety of PD-1 Inhibitor combined with DNA methyltransferase inhibitor Azacytidine and HAG regimen for patients with relapsed and refractory acute myeloid leukemia.
详细描述
Treatment for Acute Myeloid Leukemia（AML） that has not responded to treatment (refractory) or has returned after treatment (relapsed) often do not work. Researchers want to see if an immunotherapy drug, combined with a less intense chemotherapy, may be able to help.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Chinese guidelines for the diagnosis and treatment of relapsed and refractory acute myeloid leukemia (2017 edition)，excludes acute promyelocytic leukemia (M3、APL)
- •Hematopoietic stem cell transplantation ≥3 months, Discontinue immunosuppressant ≥3 weeks, Patients without graft-versus-host disease；
- •Be at least 18 years of age on day of signing informed consent.
- •Have a performance status of less than or equal to 2 on the Eastern Cooperative Oncology Group（ECOG） Performance Scale
- •Demonstrate adequate organ function as defined below, all screening labs should be performed before treatment initiation：
- •ALT(SGPT) less than or equal to 2.5 × Upper Limit of Norma（ULN）；
- •AST (SGOT) less than or equal to 2.5 × ULN；
- •Serum total bilirubin Less than or equal to 2.0 × ULN Note: If total bilirubin >2.0×ULN, subjects with Gilbert syndrome records are allowed to join the group
- •Serum Creatinine ≥ 30 mL/min
- •Total white blood cell (WBC) count ≤10,000/µL； Note: hydroxyurea therapy is allowed to reduce white blood cells to meet this inclusion criteria.white blood cells should be determined ≥24 hours after the last hydroxyurea administration. Final hydroxyurea administration should not ≤3 days prior to the first azacytidine administration.
- •Treatment without anthracycline or demethylation. Ability to comprehend the investigational nature of the study and provide informed consent
排除标准
- •Patients with chronic myeloid leukemia，AML of other myeloproliferative disorders Malignant neoplasms with other progression Those who can not control severe infections and other underlying diseases can not tolerate chemotherapy Patients with cardiac insufficiency： ejection fraction (EF)<30%，New York Heart Association（NYHA） standards，Cardiac insufficiency II or above Patients with liver and kidney dysfunction：Serum bilirubin (SB)≥2mg/dl，AST is 2.5 times higher than normal upper limit, serum creatinine (SCr) is more than 2.5 mg/dl Serious mental illness uncooperative Refusal to join the study
研究组 & 干预措施
Anti-PD-1 mAb Combined With Azacytidine and HAG regimen
Experimental
Anti-PD-1 mAb combined with DNA methyltransferase inhibitor Azacytidine and HAG regimen
干预措施: Visilizumab (Drug)
结局指标
主要结局
Complete remission， Incomplete blood count recovery，Partial remission（CR+CRi+PR）
时间窗: 8 months
Number of Participants (Responders) Achieving CR+CRi+PR After the Eighth Cycle Treatments
次要结局
- Overall survival (OS)(3 years)
- Overall Response Rate （ORR）(8 months)
- Event free survival（EFS）(3 years)
- Progression free survival（PFS）(3 years)
研究者
研究点 (1)
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