Integrated Treatment Protocol for Induction/Consolidation Chemotherapy and Transplantation in Adult Acute Myeloid Leukemia Multicenter Study on the Efficacy of an Integrated Treatment Approach
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Disease-Free Survival (DFS)
研究概览
简要总结
This is a multicenter, single-arm, open-label clinical study designed to evaluate the efficacy and safety of an integrated "induction-consolidation-transplantation" treatment protocol in adult patients with acute myeloid leukemia (AML, excluding M3 subtype). Based on patients' economic conditions, two induction regimens are offered: the IAV regimen (idarubicin + cytarabine + venetoclax) for those with better financial resources, and the DAV regimen (daunorubicin + cytarabine + venetoclax) for those with limited resources. During the consolidation phase, patients receive either the MA regimen (liposomal mitoxantrone + intermediate-dose cytarabine) or intermediate-dose cytarabine monotherapy. Eligible patients proceed directly to allogeneic hematopoietic stem cell transplantation (allo-HSCT), with a FA-BuCy/ATG conditioning regimen and an innovative graft-versus-host disease (GVHD) prophylaxis strategy using anti-CD25 monoclonal antibody combined with delayed oral cyclosporine. The entire treatment plan is designed to be completed within four months of diagnosis. The study plans to enroll 50 newly diagnosed patients aged 14-65 years. Primary endpoints include disease-free survival (DFS), complete remission rate (CR/CRi), and the efficacy of the transplantation protocol. Secondary endpoints include relapse rate, treatment-related mortality, 2-year overall survival, and treatment safety. This study aims to explore a new strategy to improve the cure rate of AML by optimizing drug combinations and shortening the treatment duration.
详细描述
Intervention Measures
- Induction and Consolidation Treatment Regimen 1.1 First Induction Therapy: IAV or DAV Regimen
- IAV Regimen:Intravenous Idarubicin (Ida): 6 mg/m²/day on days 1-3 (total cumulative dose ≤ 40 mg)，Intravenous Cytarabine: 100 mg/m²/day on days 1-7，Oral Venetoclax: 8-day schedule（100 mg on day 4, 200 mg on day 5, and 400 mg/day on days 6-11）
- DAV Regimen：Intravenous Daunorubicin (D): 60 mg/m²/day on days 1-3，Intravenous Cytarabine: 100 mg/m²/day on days 1-7，Oral Venetoclax: 8-day schedule（100 mg on day 4, 200 mg on day 5, and 400 mg/day on days 6-11） 1.2 Consolidation Therapy Options: MA or Intermediate-Dose Cytarabine Regimen
- MA Regimen (Liposomal Mitoxantrone + Intermediate-Dose Cytarabine):Liposomal Mitoxantrone: 10 mg/m²/day on days 1-2.Cytarabine: 1 g/m² every 12 hours for 3 days (days 1-3).
- Intermediate-Dose Cytarabine Regimen:Cytarabine: 1 g/m² every 12 hours for 3 days (days 1-3).
Summary:
- For patients with good economic conditions: IAV → MA regimen.
- For patients with limited economic resources: DAV → Intermediate-dose cytarabine regimen.
- Subsequent Treatment Plan for Transplant-Eligible Patients Patients eligible for allogeneic hematopoietic stem cell transplantation (allo-HSCT) should proceed directly to transplant after the above two treatment cycles（The requirement before transplantation is that minimal residual disease should be negative).
- Conditioning Regimen: FA + BuCy (Fludarabine + Busulfan + Cyclophosphamide). For haploidentical transplantation, ATG (antithymocyte globulin) is added.
- Donor Selection Priority:
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 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 14 years - 65 years;
- •Excluding AML-M3 (Acute Promyelocytic Leukemia) patients;
- •Diagnosis conforming to the Chinese Diagnosis and Treatment Guidelines for Adult Acute Myeloid Leukemia (Non-APL) (2023 Edition), including low-risk, intermediate-risk, and high-risk patients;
- •Bone marrow morphology indicating hypercellularity or hypocellularity;
- •Eastern Cooperative Oncology Group Performance Status (ECOG-PS) score of 0-2.
排除标准
- •Presence of intracranial hemorrhage;
- •Pregnancy;
- •Psychiatric illness or other conditions precluding protocol adherence;
- •Severe cardiac arrhythmia, abnormal ECG (QTc >500 ms).
研究组 & 干预措施
Efficacy of Integrated Induction-Consolidation Chemotherapy and Transplantation for Adult Acute Myel
干预措施: Integrated IAV/MA Chemotherapy and Allo-HSCT Protocol for Adult AML (Other)
Efficacy of Integrated Induction-Consolidation Chemotherapy and Transplantation for Adult Acute Myel
干预措施: First Induction (IAV or DAV Regimen) (Drug)
Efficacy of Integrated Induction-Consolidation Chemotherapy and Transplantation for Adult Acute Myel
干预措施: Subsequent Treatment Plan for Transplant-Eligible Patients (Other)
Efficacy of Integrated Induction-Consolidation Chemotherapy and Transplantation for Adult Acute Myel
干预措施: Allogeneic Stem Cell Transplantation Protocol (Other)
Efficacy of Integrated Induction-Consolidation Chemotherapy and Transplantation for Adult Acute Myel
干预措施: GVHD Prophylaxis Regimen (Other)
Efficacy of Integrated Induction-Consolidation Chemotherapy and Transplantation for Adult Acute Myel
干预措施: Subsequent Consolidation Therapy for Transplant-Ineligible Patients (Other)
结局指标
主要结局
Disease-Free Survival (DFS)
时间窗: 24 months
The Complete Response (CR) rate
时间窗: 24 months
The Complete Response (CR) rate refers to the proportion of patients achieving complete remission in a treatment regimen.
Partial Response (PR) rate
时间窗: 24 months
The Partial Response (PR) rate in oncology indicates the proportion of patients experiencing a significant reduction in tumor size post-treatment.
No Remission (NR)
时间窗: 24 months
Non-Response (NR) in medicine refers to the lack of therapeutic response, indicating no significant improvement in a patient's condition post-treatment.
CR with incomplete hematologic recovery (CRi)
时间窗: 24 months
Therapeutic efficacy
时间窗: 24 months
The efficacy of the preparative regimen and anti-GVHD regimen for allogeneic stem cell transplantation in AML patients.
次要结局
- Treatment-Related Mortality (TRM)(24 months)
- Event-Free Survival (EFS)(24 months)
- Therapeutic efficacy(24 months)
- Overall Survival (OS)(24 months)
- Adverse Event(24 months)