NCT01288378已完成3 期
Empirical Versus Pre-emptive (Diagnostic-driven) Antifungal Therapy of Patients Treated for Haematological Malignancies or Receiving an Allogeneic Stem Cell Transplant. A Therapeutic Open Label Phase III Strategy Study of the EORTC Infectious Diseases and Leukemia Groups
European Organisation for Research and Treatment of Cancer - EORTC16 个研究点 分布在 6 个国家目标入组 556 人开始时间: 2012年3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
- 入组人数
- 556
- 试验地点
- 16
- 主要终点
- Overall survival at 42 days after randomization
研究概览
简要总结
RATIONALE: Caspofungin acetate may be effective in treating fungal infections in patients with acute myeloid leukemia or myelodysplastic syndrome who are receiving treatment for their cancer. It is not yet known whether caspofungin acetate is more effective when treatment starts after development of a fever or after the infection is shown in laboratory test, chest x-ray, or CT scan.
PURPOSE: This randomized phase III trial is studying the best time to start caspofungin acetate therapy in treating patients with acute myeloid leukemia or myelodysplastic syndrome that is newly diagnosed or in first relapse.
详细描述
OBJECTIVES:
Primary
- To compare empirical approach (i.e., fever driven) versus preemptive approach (i.e., diagnostic driven), for starting antifungal therapy with caspofungin acetate, in patients with acute myeloid leukemia or myelodysplastic syndrome who are starting chemotherapy (for attaining remission induction) or myeloablation (to prepare for an allogeneic hematopoietic stem cell transplantation) for newly diagnosed disease or disease in first relapse.
Secondary
- To evaluate clinical validity and utility of a standardized Aspergillus PCR assay.
- To evaluate clinical validity and utility of beta-D-glucan.
- To determine the occurrence of single nucleotide polymorphisms (SNPs) and the predictive value of SNPs for identifying patients at higher risk of developing invasive fungal infection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Empirical
Active Comparator
Empirical approach (fever driven) for starting antifungal therapy
干预措施: caspofungin acetate (Drug)
Pre-emptive
Experimental
Pre-emptive approach (diagnostic driven) for starting antifungal therapy
干预措施: caspofungin acetate (Drug)
结局指标
主要结局
Overall survival at 42 days after randomization
时间窗: 6 weeks after randomization
次要结局
- Safety (adverse event [AE] and serious adverse event [SAE]) as assessed by CTCAE criteria v4.0(during 84 days after randomization)
- Costs related to the strategy for initiating and monitoring antifungal treatment during the 42 and 84 days following randomization(during 84 days after randomization)
- Development of proven or probable invasive fungal disease (IFD) during the 42 and 84 days following randomization(during 84 days after randomization)
- Overall survival at 84 days after randomization(12 weeks after randomization)
- Survival-free of fungal infection during the 42 and 84 days following randomization(during 84 days after randomization)
- Number of days under caspofungin treatment or under another antifungal treatment administered after caspofungin (evaluation will be done at day 42 and day 84 after randomization)(at day 42 and day 84 after randomization)
- Proper management according to allocated treatment arm (i.e., appropriate administration of caspofungin acetate in compliance to protocol, and compliance to the treatment strategy) during the 42 and 84 days after randomization(during 84 days after randomization)
研究者
研究点 (16)
Loading locations...
相似试验
已完成
2 期
Caspofungin Acetate in Treating Aspergillosis in Patients With Hematologic Cancer or in Patients Who Have Undergone a Stem Cell TransplantCancerNCT00110045European Organisation for Research and Treatment of Cancer - EORTC171
已完成
不适用
Caspofungin or Micafungin as Empiric Antifungal Therapy for Persistent Fever and NeutropeniaFebrile NeutropeniaNCT00723073Brigham and Women's Hospital323
已完成
不适用
Caspofungin Acetate in Treating Children With Fever and NeutropeniaFever, Sweats, and Hot FlashesInfectionKidney CancerNeutropeniaLymphomaLeukemiaSarcomaNeuroblastomaNCT00020527National Cancer Institute (NCI)
已完成
不适用
Anti-fungal Strategies in Acute-on-Chronic Liver Failure PatientsAntifungal AgentsInvasive Fungal InfectionsMycosesAcute-On-Chronic Liver FailureNCT04157465Post Graduate Institute of Medical Education and Research, Chandigarh216
进行中（未招募）
1 期
Empirical versus pre-emptive antifungal therapy of patients withhaematological malignanciesEmpirical versus pre-emptive (diagnosticdriven)antifungal therapy of patients treated for haematological malignancies or receiving an allogeneic stem cell transplant. A therapeutic open label phase IIIstrategy study of the EORTC Infectious Diseases and Leukemia Groups.Invasive fungal infection in patients with hematological malignancies.MedDRA version: 14.1Level: LLTClassification code 10017544Term: FungemiaSystem Organ Class: 10021881 - Infections and infestationsEUCTR2010-020814-27-NLEORTC556