Optimize First-line Treatment for Systemic Light Chain Amyloidosis With t (11; 14)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 41
- 试验地点
- 7
- 主要终点
- Overall CHR rate at 6 months
研究概览
简要总结
Achievement of complete hematologic response (CHR) is vital for systemic AL amyloidosis. Currently, the CHR rate of daratumumab, bortezomib, and dexamethasone (DBD) is close to 60%. Considering that Bcl-2 inhibitor is effective for AL amyloidosis with t(11; 14) and the median hematologic onset time of DBD is 7 days. We design a a prospective study on AL amyloidosis with t(11; 14). All patients receive DBD at the beginning. Patient will receive DBD for at least 6 cycles if achieve rapid hematologic response at day 7, while other patients will receive daratumumab, venetoclax and dexamethasone.
详细描述
The goal of this clinical trial is to optimize the first line treatment for systemic AL amyloidosis with t(11;14). The aim of this study is to pursue early complete hematologic response. The primary endpoint is overall complete hematologic response (CHR) rate at 6 months. Participants will be treated according to the hematologic response after 7 days. If the patient get rapid response after 7 days, he/she will receive daratumumab, venetoclax and dexamethasone (DBD) for at least 6 cycles. If the patient do not get rapid response, he/she will receive daratumumab, venetoclax and dexamethasone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of systemic AL amyloidosis;
- •Daratumumab, bortezomib, dexamethasone used in 1st line treatment;
- •Life expectancy greater than 12 weeks;
- •HGB ≥70g/L;
- •Blood oxygen saturation >90%;
- •Total bilirubin (TBil) ≤3×upper limit of normal (ULN); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3.0×ULN;
- •Informed consent explained to, understood by and signed by the patient.
排除标准
- •Fulfill with the criteria of active multiple myeloma or active lymphoplasmacytic lymphoma.
- •Presence of other tumors which is/are in advanced malignant stage and has/have systemic metastasis;
- •Severe or persistent infection that cannot be effectively controlled;
- •Presence of severe autoimmune diseases or immunodeficiency disease;
- •Patients with active hepatitis B or hepatitis C ([HBVDNA+] or [HCVRNA+]);
- •Patients with HIV infection or syphilis infection;
- •Any situations that the researchers believe will increase the risks for the subject or affect the results of the study.
研究组 & 干预措施
Non-Rapid Response Group
Daratumumab, venetoclax, dexamethasone
干预措施: Dexamethasone (Drug)
Rapid Response Group
Daratumumab, bortezomib, dexamethasone
干预措施: Dexamethasone (Drug)
Rapid Response Group
Daratumumab, bortezomib, dexamethasone
干预措施: Daratumumab (Drug)
Rapid Response Group
Daratumumab, bortezomib, dexamethasone
干预措施: Bortezomib (Drug)
Non-Rapid Response Group
Daratumumab, venetoclax, dexamethasone
干预措施: Daratumumab (Drug)
Non-Rapid Response Group
Daratumumab, venetoclax, dexamethasone
干预措施: Venetoclax (Drug)
结局指标
主要结局
Overall CHR rate at 6 months
时间窗: Overall CHR rate at 6 months
Overall complete hematologic response rate at 6 months
次要结局
- MRD status at 6 months(MRD status at 6 months)
- TRAEs(TRAEs)
- Hepatic response at 6 months(Hepatic response at 6 months)
- Estimated 2-year OS(Estimated 2-year overall survival)
- Cardiac response at 6 months(Cardiac response at 6 months)
- Renal response at 6 months(Renal response at 6 months)
- Estimated 2-year PFS(Estimated 2-year PFS)
研究者
Jin Lu, MD
Principal Investigator
Peking University People's Hospital