INCB88888-040 Multicenter Prospective Real-world Observational Cohort Study to Evaluate the Effectiveness of Tafasitamab in Combination With Lenalidomide Followed by Tafasitamab Monotherapy in Relapsed or Refractory Diffuse Large B-cell Lymphoma Non-transplant Eligible Patients in Italy (PRO-MIND)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Progression free survival (PFS)
研究概览
简要总结
The PRO-MIND study is an Italian, multicenter, prospective observational cohort study to evaluate the effectiveness and the safety of tafasitamab in combination with lenalidomide followed by tafasitamab monotherapy in patient with DLBCL.
详细描述
This is an Italian, multicenter, prospective observational cohort study to collect data on patients with non-transplant eligible R/R DLBCL treated with tafasitamab plus lenalidomide followed by tafasitamab in monotherapy, as second, third and fourth treatment line in a real-world clinical practice setting.
The study is non-interventional; all treatment decisions are made at the discretion of the patient's healthcare provider and are not mandated by the study design or protocol.
Since this is an observational study of real-world treatment practices and outcomes, no study medication will be provided as a part of this study. Tafasitamab and lenalidomide will be provided through usual commercial channels for medicines prescription. Tafasitamab and lenalidomide will not be provided free of charge by the sponsor.
Physicians will make all treatment decisions according to their usual clinical practices and will provide prescriptions for their patients as appropriate. The decision to treat the patient with tafasitamab must have been taken prior to and independently of the patient's inclusion in the study. There are no mandatory protocol procedures or diagnostic tests.
This is a prospective observational study: patients will be eligible to enter the study if the treatment with tafasitmab plus lenalidomide is started and when all the ethical and contract procedures with the site have been completed and after the site initiation visit date.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Patients are aged 18 years or older.
- •Patients with DLBCL R/R disease non-transplant eligible.
- •Patients who will initiate the treatment with commercially available tafasitamab and lenalidomide after the ICF signature. The decision to prescribe tafasitamab must have been made prior and regardless of the enrollment of the patient in the study.
- •Patients are able of giving the signed informed consent.
排除标准
- •Concomitant participation in an interventional clinical study
- •Any patient in the physician's opinion from whom initial diagnosis or follow-up data is unlikely to be obtained reliably data for the purposes of this observational study.
- •Patients who started tafasitamab treatment before signing the ICF.
结局指标
主要结局
Progression free survival (PFS)
时间窗: At the beginning of Cycle 1 (day 1 of this cycle. The duration of each cycle is 28 days), visit in the 1° year (every 3 months) and visit in the 2°, 3°, 4° years (every 6 months).
PFS is defined as the time from the date of treatment initiation until the first documented progression or relapse of disease measured by routine clinical care by the physician.
次要结局
- Overall Survival (OS)(Cycle 1 day 1, Visit in the 1° year(every 3 months) and visit in the 2°, 3°, 4° years (every 6 months).)
- Health economics - Concomitant Treatments(Visit in the 1° year (every 3 months) and visit in the 2°, 3°, 4° years (every 6 months))
- Health economics - Monitoring activities(Visit in the 1° year (every 3 months) and visit in the 2°, 3°, 4° years (every 6 months))
- Time to response(Visit in the 1° year(every 3 months) and visit in the 2°, 3°, 4° years (every 6 months).)
- Information of which treatment the patients will get after tafasitamab discontinuation(Visit in the 1° year (every 3 months) and visit in the 2°, 3°, 4° years (every 6 months))
- Baseline Characteristics(Baseline, At the beginning of Cycle 1 (day 1 of this cycle. The duration of each cycle is 28 days), visit in the 1° year(every 3 months) and visit in the 2°, 3°, 4° years(every 6 months).)
- Duration of Response (DoR)(Visit in the 1° year (every 3 months) and visit in the 2°, 3°, 4° years (every 6 months).)
- Time to next treatment (TTNT)(At the beginning of Cycle 1 (day 1 of this cycle. The duration of each cycle is 28 days), visit in the 1° year (every 3 months) and visit in the 2°, 3°, 4° years (every 6 months).)
- Safety of tafasitamab in monotherapy(At the beginning of Cycle 1 (day 1 of this cycle. The duration of each cycle is 28 days), Visit in the 1° year(every 3 months) and visit in the 2°, 3°, 4° years (every 6 months))
- Describe the treatment adherence of lenalidomide and dose reduction.(At the beginning of Cycle 1 (day 1 of this cycle. The duration of each cycle is 28 days), Visit in the 1° year (every 3 months) and visit in the 2°, 3°, 4° years (every 6 months))
- Health economics - Hospitalization(Visit in the 1° year (every 3 months) and visit in the 2°, 3°, 4° years (every 6 months))
- Disease Control Rate (DCR)(Baseline, At the beginning of Cycle 1 (day 1 of this cycle. The duration of each cycle is 28 days), Visit in the 1° year (every 3 months) and visit in the 2°, 3°, 4° years (every 6 months))
- Event Free Survival (EFS)(Visit in the 1° year(every 3 months) and visit in the 2°, 3°, 4° years (every 6 months).)
- Progression-Free-Survival 2 (PFS2)(Visit in the 1° year (every 3 months) and visit in the 2°, 3°, 4° years (every 6 months).)
- Health-Related Quality of Life (HRQoL)(Baseline, Visit in the 1° year(every 3 months) and visit in the 2°, 3°, 4° years (every 6 months).)
- Health economics - Unplanned specialist visits(Visit in the 1° year (every 3 months) and visit in the 2°, 3°, 4° years (every 6 months))
- Overall Response Rate (ORR)(Visit in the 1° year (every 3 months) and visit in the 2°, 3°, 4° years (every 6 months).)
- Health economics - monitoring activities performed after patients' discharge(Visit in the 1° year (every 3 months) and visit in the 2°, 3°, 4° years (every 6 months))
- Health economics - Adverse event treatment(Visit in the 1° year (every 3 months) and visit in the 2°, 3°, 4° years (every 6 months))
- Safety of tafasitamab combined with lenalidomide(At the beginning of Cycle 1 (day 1 of this cycle. The duration of each cycle is 28 days), Visit in the 1° year (every 3 months) and visit in the 2°, 3°, 4° years (every 6 months))
- Health economics - DLBCL treatment(Visit in the 1° year (every 3 months) and visit in the 2°, 3°, 4° years (every 6 months))
- Exploratory objectives(Baseline, At the beginning of Cycle 1 (day 1 of this cycle. The duration of each cycle is 28 days), Visit in the 1° year (every 3 months) and visit in the 2°, 3°, 4° years (every 6 months))