An Observational Study of Bortezomib (BTZ) Treatment on Mantle Cell Lymphoma (MCL) in China
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 54
- 试验地点
- 9
- 主要终点
- Participants Disease Status (newly diagnosed MCL or relapsed/refractory mantel cell lymphoma [rrMCL]) Treated With BTZ
研究概览
简要总结
The purpose of the study (retrospective and prospective) is to describe participant and disease characteristics and treatment pattern of Bortezomib treated mantle cell lymphoma (MCL) participants in China.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Participants that have been hospitalized for MCL after January 1st
- •Biopsy proven MCL as evidenced by histology with either immunohistochemistry (IHC) or t(11,14) translocation
- •Retrospective group: Participants who have finished BTZ treatment before the study initiation as judged by participating site physician
- •If participant isn't accessible for oral or written informed consent, ICF can be waived after approved by the IRB
- •Prospective group: Participants who are on BTZ at the time of study initiation or start BTZ after study initiation
排除标准
- •Participants with documented diagnosis of other cancers prior to or at the presence of the diagnosis of MCL
- •Participants enrolled in interventional clinical trials of BTZ or any other drug for MCL
- •Prospective group: Participants with contraindication listed in the prescribing information of BTZ
结局指标
主要结局
Participants Disease Status (newly diagnosed MCL or relapsed/refractory mantel cell lymphoma [rrMCL]) Treated With BTZ
时间窗: Baseline
Categorical variable (disease status) will be summarized using a frequency distribution with the number and percentage of participants in each category. Treatment response will be analyzed by this variable if newly diagnosed MCL patients account for more than 20 percent (%) of total.
Treatment Pattern of Bortezomib (BTZ) Treated MCL Participants: Reason of BTZ Initiation/Discontinuation/Dose Adjustment
时间窗: Up to Follow-up (approximately 22 months)
The reason of BTZ initiation/discontinuation/dose adjustment will be described with respective number of occurrence.
Demographic Characteristic of Participants in Prospective Group: Age
时间窗: Baseline
Continuous variable (age) will be summarized using descriptive statistics.
Prognostic Index Score
时间窗: Baseline
Prognostic index will be summarized using descriptive statistics. For each prognostic factor, 0-3 points are given to each patient and points are summed up to a maximum of 11. Participants with 0-3 points are classified as low risk (44% of participants, median overall survival \[OS\] not reached). Participants with 4-5 points are classified as intermediate risk (35%, median OS 51 months), and patients with 6-11 points as high risk (21%, median OS 29 months).
Eastern Cooperative Oncology Group (ECOG) Performance Status
时间窗: Baseline
A worsening in Eastern Cooperative Oncology Group (ECOG) performance status score was defined as greater than or equal to 1-point increase from Baseline. ECOG is a 5-point scale 0=Fully active, 1=Ambulatory, carry out work of sedentary nature, 2=Ambulatory, capable of all self-care, 3=Capable of limited self-care, confined to bed or chair more than 50% of waking hours, 4=Completely disabled, no self-care, totally confined to bed or chair, 5=Dead.
Ann Arbor Stage
时间窗: Up to Follow-up (approximately 22 months)
Ann Arbor stage can be obtained from imaging results or directly from admission records. Ann Arbor stage describes areas of involvement; Stage I(IE) - One lymph node region or extralymphatic site (IE); Stage II(IIE)- Two or more lymph node regions or at least one lymph node region plus a single localized extralymphatic site (IIE) on the same side of the diaphragm; stage III (IIIE, IIIS)-Lymph node regions or lymphoid structures (example, thymus,Waldeyer's ring) on both sides of the diaphragm with optional localised extranodal site (IIIE) or spleen (IIIS); stage IV-Diffuse or disseminated extralymphatic organ involvement.
Treatment pattern of BTZ-treated MCL participants: Route of Administration
时间窗: Up to Follow-up (approximately 22 months)
Primary MCL therapy with Velcade (BTZ) prior MCL treatment, combined MCL treatment and subsequent MCL treatment to extract the information on route of administration (subcutaneous \[SC\] or intravenous \[IV\]) to see if there's any outstanding factor that impacts BTZ's dose/frequency and identify the most popular usage of BTZ.
Treatment Pattern of Bortezomib (BTZ) Treated MCL participants: Dose
时间窗: Up to Follow-up (approximately 22 months)
The cumulated dose will be summarized using descriptive statistics.
Treatment Pattern of Bortezomib (BTZ) Treated MCL Participants: Frequency
时间窗: Up to Follow-up (approximately 22 months)
The frequency of BTZ will be summarized using a frequency distribution with the number and percentage of participants in each category.
Demographic Characteristic of Participants in Prospective Group: Gender
时间窗: Baseline
Categorical variable (gender) will be summarized using a frequency distribution with the number and percentage of participants in each category.
次要结局
- Overall Response Rate (ORR)(Approximately 22 months)
- Time to Response (TTR)(Approximately 22 months)
- Progressive-Free Survival (PFS)(Approximately 22 months)
- Overall survival (OS)(Approximately 22 months)
- Complete Response [CR] Rate (CR+ Unconfirmed Complete Remission CRu)(Approximately 22 months)
- Partial Remission (PR) Rate(Approximately 22 months)
- Duration of Response (DOR)(Approximately 22 months)