NCT02323022已完成3 期
IAC Regimen Versus IA Regimen as Induction Treatment for Initially Diagnosed AML Patients: a Randomized Controlled Phase III Clinical Trial
The First Affiliated Hospital of Soochow University1 个研究点 分布在 1 个国家目标入组 618 人开始时间: 2014年12月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 618
- 试验地点
- 1
- 主要终点
- Complete Remission Rate
研究概览
简要总结
The goal of this clinical trial is to compare the clinical efficacy and safety of IAC regimen and IA regimen as induction chemotherapy for initial diagnosed acute myeloid leukemia (AML) patients. The main question it aims to answer is:
•Does IAC regimen higher the complete remission rate in initial diagnosed AML patients? Researchers will compare IAC regimen to IA regimen to see if IAC works to treat AML.
Participants will:
- Receive IAC or IA as induction regimen
- Receive a second cycle of re-induction if partial remission
- Visit the clinic once every 3 to 6 months for assessment
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
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Initially diagnosed as AML (except APL)
- •Aged between 18 and 60 year old
- •Eastern Cooperative Oncology Group (ECOG) score no more than 3
- •Informed consent file (ICF) signed
排除标准
- •AML secondary to chronic leukemia and myeloproliferative neoplasms (MPNs)
- •With other underlying malignancies
- •Severe and uncontrolled infection
- •Intolerant to the chemotherapy
研究组 & 干预措施
IAC regimen
Experimental
Receive IAC induction therapy
干预措施: IAC regimen (Drug)
IA regimen
Active Comparator
Receive an IA induction therapy
干预措施: IA regimen (Drug)
结局指标
主要结局
Complete Remission Rate
时间窗: 1-2 months
complete remission (CR) rate after the induction courses
次要结局
- Overall Survival(2 years)
- Disease-Free Survival(2 years)
- Cumulative Incidence of Relapse (CIR)(2 years)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
3 期
R-ICE Versus R-DHAP in Patients Aged 18-65 With Relapse Diffuse Large B-cell LymphomaLymphoma, Large-Cell, DiffuseNCT00137995Lymphoma Study Association481
Unknown
早期 1 期
Intra-arterial Infusion Chemotherapy Combined With Sodium Bicarbonate for Unresectable Gastric CancerSuccessful Conversion Rate of OperationUnresectable Gastric CancerNCT03822130Second Affiliated Hospital, School of Medicine, Zhejiang University150
招募中
3 期
Concurrently vs Sequentially Combined HAIC With Targeted and Immunotherapy in Potentially Resectable HCCChemotherapy EffectChemotherapeutic ToxicityHepatocellular CarcinomaNCT06041477Sun Yat-sen University540
已完成
1 期
A Study of ICP-022 in Patients With Systemic Lupus Erythematosus (SLE)Systemic Lupus ErythematosusNCT04305197Beijing InnoCare Pharma Tech Co., Ltd.60
尚未招募
不适用
Intra-articular Injection Versus Normal Rehabilitation Therapy on Temporomandibular Joint DysfunctionTemporomandibular Joint DysfunctionNCT06328998Copka Sonpashan80