NCT02872987招募中不适用
Prospective Data Collection Regarding Diagnosis, Treatment and Outcome of Adult ALL Patients and Related Diseases Associated With a Prospective Collection of Biomaterial
Goethe University161 个研究点 分布在 2 个国家目标入组 10,000 人开始时间: 2009年2月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 10,000
- 试验地点
- 161
- 主要终点
- Overall survival
研究概览
简要总结
The GMALL registry serves the purpose of ALL research and quality assurance. The Registry collects data about diagnostics, treatment and outcome of Adult ALL Patients in the clinical routine, whether or not the patient is treated within a clinical trial.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
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
- •Acute Lymphoblastic Leukemia (All Subtypes) if treated according to ALL protocols
- •Other Types of Leukemia (NK Cell Lymphoma/Leukemia, Biphenotypic Acute Leukemia) if treated according to ALL protocols
- •Non-Hodgkin's Lymphoma of Following Subtypes: Burkitt Lymphoma, B Cell Lymphoma, B- or T-lineage Lymphoblastic Lymphoma, Anaplastic Large Cell Lymphoma, Other NHL) if treated according to B-ALL protocols
- •Age minimum 18 yrs
排除标准
- 未提供
研究组 & 干预措施
B-ALL/NHL
ALL/ Lymphoblastic Lymphoma (LBL)
结局指标
主要结局
Overall survival
时间窗: up to 10 years
次要结局
- Relapse rate(up to 10 years)
- Early mortality(during induction therapy with a duration of approximately 6 - 8 weeks)
- Event free survival(up to 10 years)
- Quality of life assessed by Quality of Life Questionnaire (QLQ-C30)(after treatment which is approximately 2.5 years from diagnosis)
- Molecular remission rate(after induction and consolidation, approximately 6 - 8 weeks from diagnosis)
- Remission duration(up to 10 years)
- Disease free survival(up to 10 years)
- Toxicities assessed by CTCAE v4.03(during treatment with an approximate duration of 2.5 years from diagnosis)
- Eastern Cooperative Oncology Group (ECOG) status(Time of diagnosis and up to 10 years during regular follow-up requests which are not pre-specified)
- Hematologic remission rate(after induction and consolidation, approximately 6 - 8 weeks from diagnosis)
- Positron Emission Tomography (PET) based remission evaluation(after induction and consolidation, approximately 6 - 8 weeks from diagnosis)
- Mortality in Clinical Remission (CR)(up to 10 years)
- Comorbidities(Time of diagnosis and up to 10 years during regular follow-up requests which are not pre-specified)
研究者
Nicola Goekbuget
Head of GMALL
Goethe University
研究点 (161)
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