Venetoclax Combined With CACAG Regimen Versus "3+7" Regimen in the Treatment of Acute Monocytic Leukemia: A Prospective, Randomized, Controlled Study
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 204
- 试验地点
- 3
- 主要终点
- Composite Complete Remission Rate
研究概览
简要总结
This study is a multicenter, randomized, prospective Phase II clinical trial designed to compare the effectiveness of two treatment approaches for patients with acute monocytic leukemia.
详细描述
This study is a multicenter, randomized, prospective Phase II clinical trial designed to compare the effectiveness of two treatment approaches for patients with acute monocytic leukemia.
A total of 204 participants, aged 14 to 60 years, will be enrolled across multiple study sites in China. Participants will be randomly assigned to one of two treatment groups:
Group 1: Venetoclax combined with the CACAG (cytarabine, azacitidine, chidamide, aclarubicin and granulocyte colony-stimulating factor) regimen This group will receive a combination of azacitidine, cytarabine, aclarubicin, chidamide, and venetoclax, along with granulocyte colony-stimulating factor (G-CSF) support.
Group 2: The standard "3+7" regimen This group will receive standard induction chemotherapy with daunorubicin and cytarabine.
The total study treatment period is about 8-10 weeks, consisting of two treatment cycles. Participants who do not achieve at least a partial response after the first cycle may be withdrawn from the study to receive alternative treatment as recommended by clinical guidelines.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 14 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Voluntary participation with written informed consent signed by the participant or a legal guardian; willingness to comply with all study procedures.
- •Age 14 to 60 years at screening, no gender restriction.
- •Diagnosis of acute monocytic leukemia according to the 2016 WHO classification, excluding acute promyelocytic leukemia.
- •No history of severe allergic reactions.
- •Liver function: ALT and AST ≤ 2.5 × upper limit of normal (ULN); total bilirubin ≤ 2 × ULN.
- •Renal function: serum creatinine ≤ 1.5 × ULN
- •No uncontrolled infection or severe psychiatric disorder.
- •ECOG performance status 0-3; life expectancy ≥ 4 months.
排除标准
- •Known hypersensitivity or contraindication to any study drug.
- •Pregnancy or lactation.
- •Active infection.
- •Long-term smoking or alcohol abuse that may interfere with study outcome evaluation.
- •Psychiatric illness or other condition that prevents informed consent or compliance with study procedures.
- •Major organ surgery within 6 weeks prior to enrollment.
- •Abnormal liver function: total bilirubin > 2× ULN, ALT/AST > 2.5 × ULN; abnormal renal function: serum creatinine > 1.5 × ULN.
- •Any condition deemed unsuitable for the study by the investigator (e.g., poor compliance, substance abuse).
研究组 & 干预措施
Venetoclax Combined with CACAG Regimen
Participants assigned to Venetoclax Combined with CACAG Regimen will receive a combination regimen consisting of venetoclax plus the CACAG. The CACAG regimen includes azacitidine administered at a dose of 75 mg/m² subcutaneously on days 1-7; cytarabine given at a dose of 75-100 mg/m² q12h intravenously on days 1-5; aclarubicin administered at a dose of 20 mg intravenously on days 1, 3, and 5; and chidamide given orally at a dose of 30 mg twice a week for two weeks. Venetoclax is administered orally with a dose ramp-up schedule: 100 mg on day 1, 200 mg on day 2, and 400 mg on days 3 through 14. If an azole antifungal agent is co-administered, the dose of venetoclax is reduced to 100 mg daily. Granulocyte colony-stimulating factor (G-CSF) is given subcutaneously at 300 μg per day until neutrophil recovery. Each treatment cycle lasts 4-5 weeks, with a total of 2 cycles.
干预措施: CACAG+VEN (Drug)
Standard "3+7" Regimen
Participants assigned toStandard "3+7" Regimen will receive the standard "3+7" induction regimen. Daunorubicin is administered intravenously at a dose of 60 mg/m² on days 1-3. Cytarabine is given intravenously at a dose of 75-100 mg/m² twice daily on days 1-7. Each treatment cycle lasts 4-5 weeks, with a total of 2 cycles. Participants who do not achieve at least a partial response after the first cycle will be withdrawn from the study and receive alternative treatment according to clinical guidelines.
干预措施: 3+7 (Drug)
结局指标
主要结局
Composite Complete Remission Rate
时间窗: At the end of Cycle 2 (each cycle is 28 days)
Proportion of participants achieving composite complete remission (CRc = CR + CRi) after one cycle of treatment. CR is defined as no clinical leukemic symptoms, hemoglobin ≥100 g/L (male) or ≥90 g/L (female/children), ANC ≥1.5×10⁹/L, platelets ≥100×10⁹/L, no blasts in peripheral blood, and bone marrow blasts ≤5% with normal erythroid and megakaryocytic lineages. CRi meets all CR criteria except residual neutropenia (ANC \<1.0×10⁹/L) or thrombocytopenia (platelets \<100×10⁹/L).
次要结局
- Complete Remission Rate after Cycle 1(At the end of Cycle 1 (each cycle is 28 days))
- Complete Remission with Incomplete Count Recovery Rate after Cycle 1(At the end of Cycle 1 (each cycle is 28 days))
- Overall Response Rate after Cycle 1(At the end of Cycle 1 (each cycle is 28 days))
- Partial Remission Rate after Cycle 1(At the end of Cycle 1 (each cycle is 28 days))
- Minimal Residual Disease Negative Rate after Cycle 1(At the end of Cycle 1 (each cycle is 28 days))
- Composite Complete Remission Rate after Cycle 1(At the end of Cycle 1 (each cycle is 28 days))
- Complete Remission Rate after Cycle 2(At the end of Cycle 2 (each cycle is 28 days))
- Complete Remission with Incomplete Count Recovery Rate after Cycle 2(At the end of Cycle 2 (each cycle is 28 days))
- Partial Remission Rate after Cycle 2(At the end of Cycle 2 (each cycle is 28 days))
- Minimal Residual Disease Negative Rate after Cycle 2(At the end of Cycle 2 (each cycle is 28 days))
- Progression-Free Survival(Up to 12 months after enrollment)
- Overall Survival(Up to 12 months after enrollment)
- Relapse Rate(Up to 12 months after enrollment)
- Duration of Remission(Up to 12 months after enrollment)
- Adverse reactions in hematology(At the end of Cycle 2 (each cycle is 28 days))
- Nonhematological adverse reactions(At the end of Cycle 2 (each cycle is 28 days))
研究者
Liping Dou
Department Director
Chinese PLA General Hospital