Multicenter Study on Integrated Treatment Regimen of Induction-Consolidation Chemotherapy and Transplantation for Adult Acute Lymphoblastic Leukemia
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 study aims to evaluate an integrated treatment protocol for adults with Philadelphia chromosome-negative acute lymphoblastic leukemia (Ph- ALL), combining induction chemotherapy, consolidation therapy, and allogeneic hematopoietic stem cell transplantation (allo-HSCT) to improve treatment efficacy and survival rates. The single-arm, open-label, multicenter study will enroll 50 newly diagnosed patients aged 18-60 years. The induction phase employs the VICP+VEN regimen (vindesine, idarubicin, cyclophosphamide, prednisone combined with venetoclax), followed by consolidation therapy with either Hyper-CVAD or CAM protocols, with eligible patients proceeding to allo-HSCT. Primary endpoints include disease-free survival (DFS) and complete remission (CR) rates, while secondary endpoints encompass relapse rate, overall survival (OS), and safety. Patients will be followed for 2 years with regular monitoring of minimal residual disease (MRD) and adverse events. The protocol is designed to reduce relapse risk through intensive therapy and transplantation, offering a potential cure for high-risk patients.The goal is to complete the entire treatment within 4 months after diagnosis.
详细描述
- Intervention Measures 1.1 Induction Therapy Regimen
VICP+VEN regimen:
- Vindesine: 3 mg/m²/day (max 4 mg), administered on days 1, 8, 15, 22.
- Idarubicin (IDA): 8 mg/m², days 1, 8, 15, 22.
- Cyclophosphamide (CTX): 500 mg/m², days 7, 21.
- Prednisone: 1 mg/kg/day, days 1-14; 0.5 mg/kg/day, days 15-28
- Venetoclax (VEN) 8-day ramp-up: Day 1: 100 mg, Day 2: 200 mg, Days 3-8: 400 mg/day 1.2 Pre-Treatment Regimen
Indications for pre-treatment:
- WBC ≥30×10⁹/L, or significant hepatosplenomegaly/lymphadenopathy.
- Laboratory signs of tumor lysis syndrome (e.g., electrolyte abnormalities).
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 18 to 60 years；
- •Diagnosis must comply with the Chinese Guidelines for Diagnosis and Treatment of Adult Acute Lymphoblastic Leukemia (2024 Edition), requiring MICM (Morphology, Immunology, Cytogenetics, and Molecular genetics) integration and WHO 2022 (5th edition) classification standards. The minimal diagnostic workup must include morphological assessment and immunophenotyping to differentiate ALL from acute myeloid leukemia (AML). All patients shall undergo bone marrow aspiration plus biopsy at initial diagnosis. A definitive ALL diagnosis requires ≥20% blasts/immature lymphocytes in bone marrow (Note: Patients with <20% blasts due to fever or glucocorticoid pretreatment require comprehensive evaluation incorporating medical history and ancillary tests for differential diagnosis)；
- •ECOG Performance Status: 0-2
排除标准
- •Intracranial hemorrhage
- •Psychiatric disorders or other conditions compromising protocol compliance
- •Severe cardiac arrhythmia with ECG abnormalities (QTc >500 ms)
研究组 & 干预措施
Multicenter Study of Combined Chemotherapy and Transplantation for Adult ALL
干预措施: Induction Therapy Regimen (Drug)
Multicenter Study of Combined Chemotherapy and Transplantation for Adult ALL
干预措施: Pre-Treatment Regimen (Drug)
Multicenter Study of Combined Chemotherapy and Transplantation for Adult ALL
干预措施: Post-CR Treatment (Other)
Multicenter Study of Combined Chemotherapy and Transplantation for Adult ALL
干预措施: Post-CR Consolidation Regimens (Drug)
Multicenter Study of Combined Chemotherapy and Transplantation for Adult ALL
干预措施: Transplant-Eligible Subsequent Therapy (Other)
Multicenter Study of Combined Chemotherapy and Transplantation for Adult ALL
干预措施: Allo-HSCT Protocol (Other)
Multicenter Study of Combined Chemotherapy and Transplantation for Adult ALL
干预措施: Non-Transplant Maintenance Therapy Options (Other)
结局指标
主要结局
Disease-free survival (DFS)
时间窗: 24 months
Complete remission (CR) rate
时间窗: 24 months
Partial remission (PR) rate
时间窗: 24 months
Non-remission (NR) rate
时间窗: 24 months
CR with incomplete hematologic recovery (CRi)
时间窗: 24 months
次要结局
- Relapse rate(24 months)
- Treatment-related mortality（TRM）(24 months)
- Event-Free Survival（EFS）(24 months)
- Overall Survival（OS）(24 months)
- Adverse Event(24 months)
- Mortality(24 months)