AGMT Austrian CLL (Chronic Lymphocytic Leukemia) Registry
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 500
- 试验地点
- 9
- 主要终点
- General Characteristics
研究概览
简要总结
For until very recently CLL has been considered an uncurable disease, with the only few exceptions of a part of patients capable of undergoing and successfully standing allogeneic stem cell transplant. However, the introduction of chemoimmunotherapy in particular the FCR (fludarabine, cyclophosphamide, rituximab) regimen has established a relevant population of IgVH mutated patients, who remain relapse-free for up to 10 years with a clear plateau at this level. However, for the largest proportion of all CLL patients the disease is still associated with a reduction in life expectancy as compared to a matched population.
The field has made further substantial progress by the introduction of BTK inhibitors and Bcl2 inhibitors, novel antibodies as well as by the understanding of the role of minimal residual disease (MRD), mutations and their clonal evolution over time as risk factors and factors governing the kind and duration of therapy.
Due to the limited follow up of frontline therapy trials using novel drugs, it is not yet clear, what the long-term results with many of the new drugs will be. Particularly, long-term PFS, the potential for cure and the long-term safety issues remain relevant parameters requiring examination, as are infections, interactions with other drugs or quality of life issues.
CLL has not been systematically assessed in Austria to date. This medical registry of the AGMT is thus the first Austrian-wide standardized documentation of this disease.
详细描述
This registry is designed as multicenter observational cohort of patients with CLL. Patient medical, testing and treatment information will be obtained through extraction of data from existing patient medical charts. Longitudinal follow-up data, including survival and tumor progression, will also be extracted from patient medical charts. This patient follow-up data will be obtained until patient death or loss to follow-up.
For documentation in the registry, no further diagnostic or therapeutic measures are required than those already necessary in general. Participation in the registry must not interfere with treatment routines. Only routine data, which has already been recorded in the patient's medical chart, is transferred to the electronic Case Report Forms. To maintain patient confidentiality, each patient will be assigned a unique patient identifying number upon enrollment; this number will accompany the patient's medical and other registry information throughout the lifetime of the registry.
A written consent must be obtained prior to the input of data. No informed consent is required from deceased patients.
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
- •The registry will include patients ≥ 18 years with CLL.
排除标准
- •There are no specific exclusion criteria.
结局指标
主要结局
General Characteristics
时间窗: 7 years
To describe general characteristics of CLL patients
Toxicities
时间窗: 7 years
To describe toxicity with a focus on infections, cardiotoxicity, nephrotoxicity, bleeding, etc.
Genetic Profiling
时间窗: 7 years
To describe genetic risk profiles
Patient Outcome
时间窗: 7 years
To describe patient outcome (complete response, partial response...) in relation to the type of treatment administered.
Proportion of CLL patients in Austria that require treatment
时间窗: 7 years
To describe the proportion of CLL patients in Austria that require treatment
Number of patients with concomitant diseases
时间窗: 7 years
To describe concomitant diseases at diagnosis of CLL
Number and type of treatment
时间窗: 7 years
To describe type and duration of treatment of CLL. Number of patients per treatment, number of treatments per patient.
次要结局
未报告次要终点