A Single-Arm, Open-Label Study of Venetoclax, Azacitidine, and Liposomal Mitoxantrone (VAM) as Induction Therapy in Newly-diagnosed Adult Patients With Acute Myeloid Leukemia (AML)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- complete remission rate after induction
研究概览
简要总结
This is a single-arm, open-label clinical trial evaluating the safety and preliminary efficacy of a novel induction regimen combining Venetoclax, Azacitidine, and Liposomal Mitoxantrone (VAM) in patients with newly diagnosed Acute Myeloid Leukemia (AML) who are eligible for intensive chemotherapy.
The study plans to enroll 27 participants. Patients will receive VAM induction therapy, followed by three cycles of intermediate-dose cytarabine consolidation. Allogeneic hematopoietic stem cell transplantation is recommended for high-risk or MRD-positive patients in remission.
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
- 14 Years 至 100 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with AML according to the WHO (2022) or ICC criteria, or with MDS/AML as defined by ICC (with 10%-20% blasts in the bone marrow)
- •Age ≥ 14 years, male or female.
- •Eastern Cooperative Oncology Group Performance Status (ECOG-PS) score of 0-
- •Meet the following laboratory requirements (tests must be performed within 7 days prior to treatment):
- •i. Total bilirubin ≤ 1.5 times the upper limit of normal (ULN) for the corresponding age group.
- •ii. AST and ALT ≤ 2.5 times ULN for the corresponding age group. iii. Serum creatinine < 1.5 times ULN for the corresponding age group. iv. Cardiac enzymes < 2 times ULN for the corresponding age group. v. Left ventricular ejection fraction (LVEF) within the normal range as measured by echocardiography (ECHO).
排除标准
- •Acute promyelocytic leukemia with PML::RARA fusion gene.
- •Acute myeloid leukemia with RUNX1::RUNX1T1 fusion gene.
- •Acute myeloid leukemia with BCR::ABL1 fusion gene.
- •Previously treated patients (defined as having received prior induction chemotherapy for AML/MDS; prior use of cytoreductive agents like hydroxyurea is allowed).
- •Concurrent active malignancy of other organs (requiring treatment).
- •Active cardiac disease, defined as one or more of the following:
- •i. History of uncontrolled or symptomatic angina. ii. Myocardial infarction within 6 months prior to study enrollment. iii. History of clinically significant arrhythmia requiring medication or causing severe symptoms.
- •iv. Uncontrolled or symptomatic congestive heart failure (> New York Heart Association [NYHA] Class 2).
- •Active, uncontrolled infectious diseases (e.g., untreated tuberculosis, pulmonary aspergillosis).
- •Any other condition that, in the opinion of the investigator, makes the patient unsuitable for study participation.
研究组 & 干预措施
VAM Induction Regimen
Single-arm study evaluating venetoclax, azacitidine, and liposomal mitoxantrone (VAM) as induction in newly diagnosed AML patients fit for intensive chemotherapy. Patients receive 1-2 cycles of VAM induction, followed by 3 cycles of intermediate-dose cytarabine consolidation. High-risk or MRD+ patients may proceed to allogeneic HSCT.
干预措施: Liposomal Mitoxantrone (Drug)
VAM Induction Regimen
Single-arm study evaluating venetoclax, azacitidine, and liposomal mitoxantrone (VAM) as induction in newly diagnosed AML patients fit for intensive chemotherapy. Patients receive 1-2 cycles of VAM induction, followed by 3 cycles of intermediate-dose cytarabine consolidation. High-risk or MRD+ patients may proceed to allogeneic HSCT.
干预措施: Azacitidine (Drug)
VAM Induction Regimen
Single-arm study evaluating venetoclax, azacitidine, and liposomal mitoxantrone (VAM) as induction in newly diagnosed AML patients fit for intensive chemotherapy. Patients receive 1-2 cycles of VAM induction, followed by 3 cycles of intermediate-dose cytarabine consolidation. High-risk or MRD+ patients may proceed to allogeneic HSCT.
干预措施: Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) (Procedure)
VAM Induction Regimen
Single-arm study evaluating venetoclax, azacitidine, and liposomal mitoxantrone (VAM) as induction in newly diagnosed AML patients fit for intensive chemotherapy. Patients receive 1-2 cycles of VAM induction, followed by 3 cycles of intermediate-dose cytarabine consolidation. High-risk or MRD+ patients may proceed to allogeneic HSCT.
干预措施: Cytarabine (Drug)
VAM Induction Regimen
Single-arm study evaluating venetoclax, azacitidine, and liposomal mitoxantrone (VAM) as induction in newly diagnosed AML patients fit for intensive chemotherapy. Patients receive 1-2 cycles of VAM induction, followed by 3 cycles of intermediate-dose cytarabine consolidation. High-risk or MRD+ patients may proceed to allogeneic HSCT.
干预措施: Venetoclax (Drug)
结局指标
主要结局
complete remission rate after induction
时间窗: up to 84 days
次要结局
- Relapse-free survival(Up to 5 years)
- 30-day mortality(up to 30 days)
- 60-day mortality(up to 60 days)
- Event-free survival(Up to 2 years)
- Overall survival(Up to 5 years)
- MRD negativity rate by flow cytometry after 1 induction cycle(At the end of the first and second induction cycles)
- MRD negativity rate by flow cytometry after 2 induction cycles(At the end of the first and second induction cycles)
- MRD negativity rate by NGS OR PCR after 1 induction cycle(up to 42 days)
- MRD negativity rate by NGS OR PCR after 2 induction cycles(up to 84 days)