NCT01595295已完成不适用
Registry on Hypomethylating Agents in Myeloid Neoplasms, Including Myelodysplastic Syndromes (MDS), Chronic Myelomonocytic Leukemia (CMML) and Acute Myeloid Leukemia (AML)
Arbeitsgemeinschaft medikamentoese Tumortherapie20 个研究点 分布在 2 个国家目标入组 1,500 人开始时间: 2009年2月9日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,500
- 试验地点
- 20
- 主要终点
- Response evaluation
研究概览
简要总结
This registry is set up to collect real-world experience in the management of patients with myeloid neoplasms, in particularly in patients with MDS, CMML or AML, treated with hypomethylating agents in Austria and potentially other participating countries. This registry will collect data in a retrospective as well as in a prospective manner at various sites. The aim is to gain valuable insights on both efficacy and toxicity of these drugs in a routine clinical setting in patients with various comorbidities.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
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
- •Patients with MDS, CMML, and AML
- •who begin with or already have received treatment with with a hypomethylating agent
- •who are willing to provide informed consent
排除标准
- •Due to the non-interventional design of this program there are no specific exclusion criteria.
结局指标
主要结局
Response evaluation
时间窗: up to 10 years
hematological response, marrow response, cytogenetic response (if data is available), quantification of reduced need for transfusions, median response duration
Overall survival
时间窗: up to 10 years
次要结局
- Documentation of adverse events and toxicities(up to 10 years)
- Number of treatment cycles(up to 10 years)
- Number and reasons of dose reductions(up to 10 years)
- Uni/multivariate analysis of various factors known or thought to influence overall survival in order to establish prognostic markers(up to 10 years)
研究者
研究点 (20)
Loading locations...
相似试验
招募中
不适用
Myeloproliferative Neoplasms (MPNs) Patient RegistryLeukemia, Myeloid, Chronic, Atypical, BCR-ABL NegativeLeukemia, Myelomonocytic, JuvenileChronic Eosinophilic Leukemia-not Otherwise SpecifiedMyelodysplastic-Myeloproliferative DiseasesNeoplasmsPolycythemia VeraLeukemia, Myelomonocytic, ChronicEssential ThrombocythemiaPrimary MyelofibrosisMastocytosisNCT02760238University Health Network, Toronto5,000
已完成
不适用
Acquired Methemoglobinemia Observational RegistryMethemoglobinemia, AcquiredMethemoglobinemiaNCT03542760Hospital Quality Foundation24
招募中
不适用
A "Physician & Patient-powered" Cohort Registry (MY MYELOMA)Multiple MyelomaNCT05001087Fondazione EMN Italy Onlus1,900
招募中
不适用
Registry Study on Patient Characteristics, Biological Disease Profile and Clinical Outcome in Acute Myeloid Leukemia and Related Neoplasms - The Biology and Outcome (BiO)-ProjectAcute Myeloid Leukemia (AML)MDS/AMLNCT01252485University of Ulm50,000
招募中
不适用
Clinical AML Registry and Biomaterial Database of the Study Alliance Leukemia (SAL)Acute Myeloid Leukemia (AML)NCT03188874Technische Universität Dresden15,000