NCT04897477Unknown1 期
An Open Label, Single Arm, Phase I/II in the Combination of Azacytidine, Bendamustine and Piamprizumab in Refractory/Relapsed B-cell Non-Hodgkin's
Chinese PLA General Hospital1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2021年4月22日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Safety: treatment-related adverse events (AEs)
研究概览
简要总结
This is an open label, single arm, phase I/II for patients with r/r Non-Hodgkin's Lymphoma
. The purpose is to evaluate the safety and efficacy of the combination with Azacytidine, Bendamustine and Piamprizumab
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
- •Age ≥18 and ≤80 years
- •Performance status (ECOG) between 0 and
- •Histologically confirmed B-cell non-Hodgkin lymphoma (NHL), including the following types defined by WHO
- •Refractory disease or relapsed after treatment with ≥2 lines of chemotherapy and either having failed autologous HSCT or being ineligible for or not consenting to autologous HSCT; or not suitable for CAR T treatment or resistance, progression or relapse after CAR T treatment; or CAR T pre-culturing losers can also be enrolled.
- •Adequate organ function.
- •An adequate bone marrow reserve.
- •Measurable or assessable disease according to the"IWG Response Criteria for Malignant Lymphoma"(Cheson 2014). Patients in complete remission (CR) with no evidence of disease were not eligible.
- •Informed consent/assent requiring that all patients have the ability to understand and the willingness to provide written informed consent.
- •Life expectancy > 12 weeks.
- •Patients with definite involvement of the gastrointestinal tract, and patients with central nervous system (CNS) by PETCT and MRI involvement were allowed to enrolled in this clinical study.
排除标准
- •Pregnant or lactating women.
- •Uncontrolled medical disorders, active bacterial, viral infection or treponema pallidum infection and so on.
- •Requirement for urgent therapy due to tumor mass effects such as respiratory obstruction or blood vessel compression.
- •Current or expected need for systemic corticosteroid therapy.
- •Any organ failure.
- •Patients with a second tumor requiring therapy or intervention.
- •Subjects considered unlikely to complete all protocol-required study visits or procedures, including follow-up visits, or comply with the study requirements for participation according to the investigator's judgement.
- •Prior organ allograft.
- •Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness.
研究组 & 干预措施
combination of Azacytidine, Bendamustine and Piamprizumab
Experimental
combination of Azacytidine, Bendamustine and Piamprizumab in Refractory/Relapsed B-cell Non-Hodgkin's Lymphoma, every 28 days
干预措施: Azacytidine, Bendamustine and Piamprizumab (Drug)
结局指标
主要结局
Safety: treatment-related adverse events (AEs)
时间窗: 6 month
Incidence, nature, and severity of adverse events graded according to the NCI CTCAE v5.0. AEs were considered to be treatment-related if they had started or worsened within the interval from first study drug administration until the follow-up visit.
次要结局
- Complete Response Rate(6 month)
- Objective Response Rate(6 month)
研究者
Han weidong
Professor
Chinese PLA General Hospital
研究点 (1)
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