NCT05996406进行中（未招募）2 期
Venetoclax Combined with Dexamethasone for Newly Diagnosed Light-Chain Amyloidosis Patients with Translocation (11;14): a Multicenter Phase 2 Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Complete response (CR)+very good partial response (VGPR) at 3 months after treatment initiation
研究概览
简要总结
Venetoclax is considered as a promising agent for light-chain (AL) amyloidosis due to the high percentage of t(11;14). Several retrospective studies showed venetoclax-based therapy could induce rapid and profound hematologic response in AL patients with favorable safety profile. As an oral agent with encouraging data, it is worth to prospectively evaluate the efficacy and safety of venetoclax in untreated AL amyloidosis patients.
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
- •Biopsy proved treatment-naïve AL amyloidosis
- •Fluorescence in situ hybridization (FISH) t(11;14) ≥ 10%
- •dFLC > 50mg/L
排除标准
- •Co-morbidity of uncontrolled infection
- •Co-morbidity of other active malignancy
- •Co-diagnosis of multiple myeloma or waldenstrom macroglobulinemia
- •Co-morbidity of grade 2 Mobitz II or grade 3 atrioventricular block (expect for those with implanted pacemaker)
- •Co-morbidity of sustained or recurrent nonsustained ventricular tachycardia
- •Seropositive for human immunodeficiency virus
- •Hepatitis B virus (HBV)-DNA > 1000 copies/mL
- •Seropositive for hepatitis C (except in the setting of a sustained virologic response)
- •Systemic treatment with moderate or strong cytochrome P450 3A （CYP3A） inducers, moderate or strong CYP3A inhibitors within 7 days prior to the first dose of study drug
- •Neutrophil <1×10E9/L，hemoglobin < 8g/dL，or platelet < 100×10E9/L.
- •Severely compromised hepatic or renal function: alanine transaminase (ALT) or aspertate aminotransferase (AST) > 2.5 × upper limit of normal (ULN), total bilirubin > 3 × ULN，eGFR < 15 mL/min, or receiving renal replacement therapy
研究组 & 干预措施
Ven-D
Experimental
Venetoclax combined with dexamethasone
干预措施: Venetoclax (Drug)
Ven-D
Experimental
Venetoclax combined with dexamethasone
干预措施: Dexamethasone Oral (Drug)
结局指标
主要结局
Complete response (CR)+very good partial response (VGPR) at 3 months after treatment initiation
时间窗: 3 months after treatment initiation
次要结局
- Overall survival(2 years)
- Time to next treatment(2 years)
- Time to hematologic CR(1 year)
- Time to cardiac response(2 years)
- Time to renal response(2 years)
- Time to hepatic response(2 years)
- CR+VGPR at 1 month after treatment initiation(1 month after treatment initiation)
- CR+VGPR at 6 months after treatment initiation(6 months after treatment initiation)
- CR+VGPR at 12 months after treatment initiation(12 months after treatment initiation)
- Difference between involved and uninvolved free light chain (dFLC) < 10mg/L(at 1, 3, 6 and 12 months after treatment initiation)
- Involved free light chain (iFLC) ≤ 20mg/L(at 1, 3, 6 and 12 months after treatment initiation)
- Minimal residual disease (MRD) negativity(12 and 24 months after treatment initiation)
- Time to hematologic response(1 year)
- Cardiac response(at 3, 6, 12 and 24 months after treatment initiation)
- Renal response(at 3, 6, 12 and 24 months after treatment initiation)
- Hepatic response(at 3, 6, 12 and 24 months after treatment initiation)
- Adverse events(treatment initiation to 30 days after last dose of treatment)
研究者
Jian Li
Professor
Peking Union Medical College Hospital
研究点 (1)
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