Zanubrutinib (Brukinsa®) in Patients With Waldenström's Macroglobulinemia (WM), Chronic Lymphocytic Leukemia (CLL), Marginal Zone Lymphoma (MZL) and Follicular Lymphoma (FL) - a Prospective Multicenter Observational Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- iOMEDICO AG
- 入组人数
- 845
- 试验地点
- 4
- 主要终点
- Medical resource utilization
研究概览
简要总结
The objective of this NIS is to evaluate medical resource utilization, where data is rare in all cohorts, patient's QoL and effectiveness of zanubrutinib treatment in adult patients with WM, CLL, MZL and FL in a real-world setting.
详细描述
ARIADNE will collect and analyze data of adult patients with WM, CLL, MZL or FL in need of treatment. The study will explore the medical resource utilization during therapy with zanubrutinib (Brukinsa®). Further aims are to assess effectiveness, safety and tolerability of the treatment as well as treatment satisfaction and biomarkers. These data will be supplemented by the assessment of patient-reported outcomes (PROs)/ health-related quality of life (QoL).
Since treatment options for MW, CLL, MZL or FL are limited and the most important factor is to keep or improve QoL of the patients, there is an urge for real-world clinical data of patients treated with zanubrutinib, especially focusing on patients already treated upfront with a BTK inhibitor, older patients and patients with comorbidities.
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
- •Waldenström's macroglobulinemia (all treatment lines) OR
- •Chronic lymphocytic leukemia (all treatment lines) OR
- •Marginal zone lymphoma (≥2 treatment line and at least one anti-CD20 antibody-based previous therapy)
- •Follicular lymphoma (≥3 treatment line)
- •Signed and dated informed consent form
- •Treatment with zanubrutinib according to current SmPC for WM, CLL and MZL
- •Treatment with zanubrutinib + obinutuzumab for FL according to current SmPC
- •Treatment decision before inclusion into this non-interventional study
- •Age ≥18 years.
排除标准
- •Contraindications according to SmPC for patients with WM, CLL, MZL or FL
- •Participation in an interventional clinical trial during zanubrutinib treatment.
研究组 & 干预措施
Waldenström's Macroglobulinemia
75 patients (excluding screening failures, patients with off-label use or with violation of inclusion/exclusion criteria identified after treatment start) receiving zanubrutinib (Brukinsa®)
干预措施: Zanubrutinib (Drug)
Chronic Lymphocytic Leukemia
690 patients (excluding screening failures, patients with off-label use or with violation of inclusion/exclusion criteria identified after treatment start) receiving zanubrutinib (Brukinsa®)
干预措施: Zanubrutinib (Drug)
Follicular Lymphoma
40 patients (excluding screening failures, patients with off-label use or with violation of inclusion/exclusion criteria identified after treatment start) receiving zanubrutinib (Brukinsa®) in combination with obinutuzumab (Gazyvaro®)
干预措施: Zanubrutinib (Drug)
Marginal Zone Lymphoma
40 patients (excluding screening failures, patients with off-label use or with violation of inclusion/exclusion criteria identified after treatment start) receiving zanubrutinib (Brukinsa®)
干预措施: Zanubrutinib (Drug)
Follicular Lymphoma
40 patients (excluding screening failures, patients with off-label use or with violation of inclusion/exclusion criteria identified after treatment start) receiving zanubrutinib (Brukinsa®) in combination with obinutuzumab (Gazyvaro®)
干预措施: Obinutuzumab (Drug)
结局指标
主要结局
Medical resource utilization
时间窗: During zanubrutinib treatment, up to 6.3 years
Frequency of hospitalizations, i.e. number of hospital stays plus number of emergency unit visits (without hospitalization) per patient
次要结局
- Global health-related quality of life (QoL) collected via EORTC QLQ-C30 during course of treatment and follow-up(During zanubrutinib treatment and follow-up, up to 6.3 years)
- Global health-related quality of life (QoL) collected via EQ-5D-5L during course of treatment and follow-up(During zanubrutinib treatment and follow-up, up to 6.3 years)
- Incidence of (serious) adverse events ((S)AEs)(Start of zanubrutinib treatment until 30 days after end of zanubrutinib treatment)
- Incidence of (serious) adverse drug reactions ((S)ADRs)(Start of zanubrutinib treatment until end of study, up to 6.3 years)
- Incidence of adverse events of special interest (AESIs)(Start of zanubrutinib treatment until 30 days after end of zanubrutinib treatment)
- Time to AESIs(Start of zanubrutinib treatment until 30 days after end of zanubrutinib treatment)
- Time to neutropenia(Start of zanubrutinib treatment until 30 days after end of zanubrutinib treatment)
- Rate of neutropenia grade ≥3(Start of zanubrutinib treatment until 30 days after end of zanubrutinib treatment)
- Proportion of patients with complete response (CR) or very good partial response (VGPR) (best reported response)(During zanubrutinib treatment, up to 6.3 years)
- In the WM cohort only: Major response rate (MRR)(During zanubrutinib treatment, up to 6.3 years)
- In the WM cohort only: Best response(During zanubrutinib treatment, up to 6.3 years)
- In the WM cohort only: IgM levels(During zanubrutinib treatment, up to 6.3 years)
- Progression-free Survival (PFS)(Treatment start with zanubrutinib until end of study, up to 6.3 years)
- 6-, 12-, 18- and 24-month PFS rate(6, 12, and 24 months after start of zanubrutinib treatment)
- Overall Survival (OS)(Treatment start with zanubrutinib until end of study, up to 6.3 years)
- 6-, 12-, 18- and 24-month OS rate(6, 12, and 24 months after start of zanubrutinib treatment)
- WM Cohort: Overall response rate (ORR)(During zanubrutinib treatment, up to 6.3 years)
- WM Cohort: Best overall response rate (ORR)(During zanubrutinib treatment, up to 6.3 years)
- CLL Cohort: Overall response rate (ORR)(During zanubrutinib treatment, up to 6.3 years)
- CLL Cohort: Best overall response rate (ORR)(During zanubrutinib treatment, up to 6.3 years)
- MZL Cohort: Overall response rate (ORR)(During zanubrutinib treatment, up to 6.3 years)
- MZL Cohort: Best overall response rate (ORR)(During zanubrutinib treatment, up to 6.3 years)
- FL Cohort: Overall response rate (ORR)(During zanubrutinib treatment, up to 6.3 years)
- FL Cohort: Best overall response rate (ORR)(During zanubrutinib treatment, up to 6.3 years)
- Time to treatment failure (TTF)(Treatment start with zanubrutinib until end of treatment, up to 6.3 years)
- Frequency of blood product transfusion(During zanubrutinib treatment, up to 6.3 years)
- WM Cohort: Change of IgM levels until end of zanubrutinib treatment(Baseline and end of zanubrutinib treatment, up to 6.3 years)
- Therapy decision making(Baseline)
- Time from first diagnosis of WM, CLL, MZL or FL to zanubrutinib treatment start(Baseline)
- Previous therapies(Baseline)
- Daily dose of zanubrutinib(During zanubrutinib treatment, up to 6.3 years)
- FL cohort: Daily dose of obinutuzumab(During zanubrutinib treatment, up to 6.3 years)
- Dose modifications of zanubrutinib(During zanubrutinib treatment, up to 6.3 years)
- FL cohort: Dose modifications of obinutuzumab(During zanubrutinib treatment, up to 6.3 years)
- Therapy interruptions of zanubrutinib(During zanubrutinib treatment, up to 6.3 years)
- FL cohort: Therapy interruptions of obinutuzumab(During zanubrutinib treatment, up to 6.3 years)
- Dose intensity of zanubrutinib(During zanubrutinib treatment, up to 6.3 years)
- FL cohort: Dose intensity of obinutuzumab(During zanubrutinib treatment, up to 6.3 years)
- Treatment duration with zanubrutinib(During zanubrutinib treatment, up to 6.3 years)
- FL cohort: Treatment duration with obinutuzumab(During zanubrutinib treatment, up to 6.3 years)
- Subsequent antineoplastic therapies(End of zanubrutinib treatment until end of study, up to 6.3 years)
- Frequency for concomitant medication during zanubrutinib treatment(During zanubrutinib treatment, up to 6.3 years)
- Frequency of antibiotic use for prophylactic reasons during zanubrutinib treatment(During zanubrutinib treatment, up to 6.3 years)
- Frequency of antibiotic use for treatment of AEs during zanubrutinib treatment(During zanubrutinib treatment, up to 6.3 years)
- Frequency of antibiotic use in patients with neutropenia during zanubrutinib treatment(During zanubrutinib treatment, up to 6.3 years)