Lenalidomide Observational Study in Patients With Mantle Lymphoma in Relapse/Refraction. Spanish Programme RRMCL Results.
试验速览
- 阶段
- 不适用
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Experience of real clinal practice lenalidomide use.
研究概览
简要总结
This is a multicentric, observational and retrospective study of the use of lenalidomide in patients with relapsed or refractory mantle cell lymphoma that are included in the RRMCL spanish program.
The lenalidomide effectiveness and tolerability data will be retrospectely collected until the 30 of April 2018.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
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
- •≥ 18 years old.
- •Diagnosed with relapsed or refractory mantle cell lymphoma verified by a tissue biopsy.
- •Treated with monotherapy or combination of lenalidomide.
- •Not candidate for any of the therapeutic options approved until that date for this disease.
- •Not candidate or unable to be included in any clinical trial due to availability or geographical difficulty.
- •Registered in the RRMCL spanish program.
排除标准
- •Patients with uncontrolled comorbidities.
- •Blastoid variant.
- •Central nervous system tumor infiltration.
- •HIV, HBV and/or HCV active infection.
- •Radiotherapy concomitant treatment or that have received radiotherapy in the previous 30 days to the beginning of the first cycle of lenalidomide.
- •Diagnosed with other active solid tumor except for basal cell carcinoma skin cancer.
- •Patients that haven´t completed at least one complete cycle of the treatment.
研究组 & 干预措施
Mantle cell lymphoma treated with lenalidomide cohort
Patients diagnosed with mantle cell lymphoma treated with leanalidomide through the RRMCL spanish program.
干预措施: Lenalidomide (Drug)
结局指标
主要结局
Experience of real clinal practice lenalidomide use.
时间窗: Start of observation period (first medical record available on site) up to last medical record available on site or the end of the observation period (31 December 2019), whichever occurred first
Results of the the usage in real clinical practice of the lenalidomide monotherapy or combination treatment in patients with relapsed or refractory mantle cell lymphoma that aren´t candidate to other alternative treatments inside the RRMCL spanish program.
次要结局
- Proportion of patients that achieve objective response.(Start of observation period (first medical record available on site) up to last medical record available on site or the end of the observation period (31 December 2019), whichever occurred first)
- Verify the disease overall survival.(Start of observation period (first medical record available on site) up to last medical record available on site or the end of the observation period (31 December 2019), whichever occurred first)
- Verify the disease free survival.(Start of observation period (first medical record available on site) up to last medical record available on site or the end of the observation period (31 December 2019), whichever occurred first)
- Evaluate the incidence of treatment adverse events.(Start of observation period (first medical record available on site) up to last medical record available on site or the end of the observation period (31 December 2019), whichever occurred first)
- Duration of the response.(Start of observation period (first medical record available on site) up to last medical record available on site or the end of the observation period (31 December 2019), whichever occurred first)