Clinical Research Platform on Treatment, Quality of Life and Outcome of Patients With Primary and Secondary Myelofibrosis and Anemia Who Are JAK Inhibitor Treatment-naïve or JAK Inhibitor Treatment-experienced (RHODOLITE)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- iOMEDICO AG
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Documentation of systemic treatment for MF and therapy sequences
研究概览
简要总结
The purpose of the project is to set up a national, prospective, longitudinal, multicenter cohort study, a tumor research platform, to document uniform data on characteristics, molecular diagnostics, treatment and course of disease and to collect patient-reported outcomes for patients with primary and secondary myelofibrosis and anemia in Germany.
详细描述
RHODOLITE is a national, prospective, open-label, longitudinal, non-interventional multicenter cohort study (research platform) to describe treatment in routine clinical practice of myelofibrosis patients in routine care in Germany.
RHODOLITE will follow patients for up to three years with the aim to identify common therapeutic sequences and changes in the treatment of the disease. At inclusion, data in patient characteristics, comorbidities, tumor characteristics and previous treatments are collected. During the course of observation data on all systemic treatments and outcome are documented.
Health-related quality of life (HRQoL) will be evaluated for up to three years.
The RHODOLITE project is a joint project with the German Study Group for Myeloproliferative Neoplasms (GSG-MPN) and its GSG-MPN Bioregistry (NCT03125707). Details on treatment and outcome will be collected in RHODOLITE for up to three years, while long-term follow-up for a minimum of additional five years will be performed in the GSG-MPN Bioregistry.
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
- •Confirmed diagnosis of primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis (MF) (Note: diagnosis according to WHO-2017, ICC-2022 or WHO-2022 or IWG-MRT criteria, respectively).
- •Diagnosis of anemia at the time of enrollment as per individual, clinical assessment by the local physician.
- •Start of first or subsequent systemic treatment for MF.
- •Informed consent and registration for the GSG-MPN Bioregistry.
- •Willingness and capability to participate in PRO assessment.
- •Signed and dated informed consent form for RHODOLITE at the latest six weeks after start of the respective systemic MF treatment.
排除标准
- •No systemic therapy for diagnosed primary or secondary MF.
- •Planned allogenic stem cell transplantation (allo-SCT) or active participation in an interventional clinical trial.
结局指标
主要结局
Documentation of systemic treatment for MF and therapy sequences
时间窗: 3 years per patient
Types and frequencies of systemic treatment for MF during observation time.
次要结局
- Overall survival(3 years per patient)
- Hematologic response(3 years per patient)
- Splenic response(3 years per patient)
- Assessment of Myelofibrosis-related symptoms(3 years per patient)
- Overall response rate (ORR)(3 years per patient)
- Health-related quality of life (Patient-reported outcome, PRO)(3 years per patient)
- Progression free survival (PFS)(3 years per patient)