A Phase 2 Study of Chidamide, Azacitidine Combined With GM Regimen for Patients With Relapsed and Refractory DLBCL
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Overall response rate(ORR)
研究概览
简要总结
To evaluate the efficacy and safety of CAGM regimen in R/R DLBCL patients and to provide a safe and more effective approach for R/R DLBCL patients.
详细描述
The study will start with an initial 2 cycles of induction therapy with CAGM containing chidamide, azacitidine, obinutuzumab and mitoxantrone liposome, orelabrutinib and rituximab，following imaging examinations to evaluate response rates. For patients feasible to CAR-T/ASCT, sequential CAR-T/ASCT treatment was given. For patients who were unable to undergo CAR-T/ASCT, 4 cycles of CAGM immunochemotherapy were carried out. Efficacy and safety of CAGM regimen in R/R DLBCL will be evaluated.
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
- •Age ≥ 18 years.
- •At least one measurable lesion，measurable lymph nodes or masses of at least 15 millimeter (mm).
- •Histopathologically confirmed DLBCL.
- •Diseases refractory to first-line treatment (including CD20 monoclonal antibody and anthracycline) or relapsed after the last treatment.
- •Life expectancy > 3 months.
- •Appropriate organ function: Cardiac function: cardiac ejection fraction ≥50%; Liver function: alanine aminotransferase and aspartate aminotransferase ≤3 times the upper limit of normal; Renal function: serum creatinine clearance ≥30 mL/min; Lung function: SPO2>91% without oxygen;
- •Adequate bone marrow reserve: Hemoglobin ≥8 g/dL; Platelet count ≥75×10^9/L; Absolute neutrophil value ≥1.0×10^9/L; Platelet count ≥50×10^9/L, absolute neutrophil value ≥0.75×10^9/L if there is bone marrow invasion.
- •The patient has the ability to understand and is willing to provide written informed consent.
- •Agreement to practice birth control from the time of enrollment until the follow-up period of the study.
排除标准
- •Severe liver and kidney dysfunction (alanine aminotransferase, bilirubin, creatinine > 3 times the upper limit of normal);
- •Structural heart disease, leading to clinical symptoms or abnormal cardiac function (NYHA ≥ grade 2);
- •Uncontrolled active infection;
- •Concurrent presence of other tumors requiring treatment or intervention;
- •Current or expected need for systemic corticosteroid therapy;
- •Pregnant or lactating women.
- •Other psychological conditions that prevent patients from participating in the research or signing the informed consent.
- •In the investigator's judgment, the subject is unlikely to complete all protocol-required study visits or procedures, including follow-up visits, or does not meet the requirements for participation in the study.
研究组 & 干预措施
Chidamide, Azacitidine Combined With GM(CAGM) Regimen
R/R DLBCL patients were treated with 2 cycles of CAGM regimen including chidamide, azacitidine, obinutuzumab and liposomal mitoxantrone followed by imaging examination. Patients achieved CR/PR were exposed to ASCT/CAR-T therapy or additional 4 cycles of CAGM regimen in patients ineligible for ASCT/CAR-T therapy; whereas, patients with SD/PD were withdrawn from this study.
干预措施: Chidamide (Drug)
Chidamide, Azacitidine Combined With GM(CAGM) Regimen
R/R DLBCL patients were treated with 2 cycles of CAGM regimen including chidamide, azacitidine, obinutuzumab and liposomal mitoxantrone followed by imaging examination. Patients achieved CR/PR were exposed to ASCT/CAR-T therapy or additional 4 cycles of CAGM regimen in patients ineligible for ASCT/CAR-T therapy; whereas, patients with SD/PD were withdrawn from this study.
干预措施: Azacitidine (Drug)
Chidamide, Azacitidine Combined With GM(CAGM) Regimen
R/R DLBCL patients were treated with 2 cycles of CAGM regimen including chidamide, azacitidine, obinutuzumab and liposomal mitoxantrone followed by imaging examination. Patients achieved CR/PR were exposed to ASCT/CAR-T therapy or additional 4 cycles of CAGM regimen in patients ineligible for ASCT/CAR-T therapy; whereas, patients with SD/PD were withdrawn from this study.
干预措施: obinutuzumab (Biological)
Chidamide, Azacitidine Combined With GM(CAGM) Regimen
R/R DLBCL patients were treated with 2 cycles of CAGM regimen including chidamide, azacitidine, obinutuzumab and liposomal mitoxantrone followed by imaging examination. Patients achieved CR/PR were exposed to ASCT/CAR-T therapy or additional 4 cycles of CAGM regimen in patients ineligible for ASCT/CAR-T therapy; whereas, patients with SD/PD were withdrawn from this study.
干预措施: Liposomal mitoxantrone (Drug)
结局指标
主要结局
Overall response rate(ORR)
时间窗: At the end of Cycle 2 (each cycle is 28 days)
The rate of patients who achieved CR or PR after treatment by CAGM regimen
Complete response rate(CRR)
时间窗: At the end of Cycle 2 (each cycle is 28 days)
The rate of patients who achieved CR after treatment by CAGM regimen
次要结局
- Incidence of Treatment-Emergent Adverse Events, Treatment-Related Adverse Events and Serious Adverse Events(initiation of study drug until 30 days after last dose)
- Progression-free survival(PFS)(Up to 24 months after the end of last patients' treatment.)
- Overal survival(OS)(Up to 24 months after the end of last patients' treatment.)
- Overall response rate(ORR)(At the end of Cycle 6 (each cycle is 28 days))
- Complete response rate(CRR)(At the end of Cycle 6 (each cycle is 28 days))