NCT02369016已完成3 期
A Randomized, Double-blind Phase III Study of Copanlisib Versus Placebo in Patients With Rituximab-refractory Indolent Non-Hodgkin's Lymphoma (iNHL) - CHRONOS-2
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 25
- 主要终点
- Number of Participants With Abnormal Vital Signs
研究概览
简要总结
To assess the safety of copanlisib.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Histologically confirmed diagnosis of indolent B-cell NHL, with histological subtype limited to the following:
- •Follicular lymphoma (FL) grade 1-2-3a.
- •Small lymphocytic lymphoma (SLL) with absolute lymphocyte count < 5 x 10*9/L at the time of diagnosis and at study entry.
- •Lymphoplasmacytoid lymphoma/Waldenström macroglobulinemia (LPL/WM).
- •Marginal zone lymphoma (MZL) (splenic, nodal, or extra-nodal).
- •Patients must have received two or more prior lines of treatment. A previous regimen is defined as one of the following: at least two months of single-agent therapy, at least two consecutive cycles of polychemotherapy, autologous transplant, radioimmunotherapy.
- •Prior therapy must include rituximab and alkylating agents.Prior exposure to idelalisib or other PI3K inhibitors is acceptable (except to copanlisib) provided that there is no resistance.
- •Patients must be refractory to the last rituximab-based treatment, defined as no response or response lasting < 6 months after completion of treatment. Time interval to assess refractoriness will be calculated between the end date (last day) of the last rituximab-containing regimen and the day of diagnosis confirmation of the subsequent relapse.
- •Patients must have at least one bi-dimensionally measurable lesion (which has not been previously irradiated) according to the Recommendations for Initial Evaluation, Staging, and Response Assessment of Hodgkin and Non-Hodgkin Lymphoma: The Lugano Classification.
- •Patients affected by WM, who do not have at least one bi-dimensionally measurable lesion in the baseline radiologic assessment, must have measurable disease, defined as presence of immunoglobulin M (IgM) paraprotein with a minimum IgM level ≥ 2 x upper limit of normal (ULN)and positive immunofixation test.
- •ECOG performance status ≤ 1
- •Adequate bone marrow, liver and renal function
排除标准
- •Histologically confirmed diagnosis of FL grade 3b.
- •Chronic lymphocytic leukemia (CLL).
- •Transformed disease (assessed by investigator):
- •histological confirmation of transformation, or
- •clinical and laboratory signs: rapid disease progression, high standardized uptake value (SUV) (> 12) by positron emission tomography (PET) at baseline if PET scans are performed (optional).
- •Bulky disease - Lymph nodes or tumor mass (except spleen) >= 7cm LD (longest diameter)
- •Known lymphomatous involvement of the central nervous system.
- •Uncontrolled arterial hypertension despite optimal medical management (per investigator's assessment).
- •Type I or II diabetes mellitus with HbA1c > 8.5% at Screening.
- •Known history of human immunodeficiency virus (HIV) infection.
- •Active clinically serious infections > CTCAE Grade 2
- •Active Hepatitis B or hepatitis C
- •History or concurrent condition of interstitial lung disease of any severity and/or severely impaired lung function (as judged by the investigator)
- •History of having received an allogeneic bone marrow or organ transplant
- •Positive cytomegalovirus (CMV) PCR test at baseline
- •Pregnant or breast-feeding patients
研究组 & 干预措施
Copanlisib (BAY 80-6946)
Experimental
patients with rituximab-refractory iNHL
干预措施: Copanlisib (BAY 80-6946) (Drug)
结局指标
主要结局
Number of Participants With Abnormal Vital Signs
时间窗: up to 7 years
- Reported as TEAEs - worst CTCAE grade total -
Number of Participants With Treatment-emergent Serious Adverse Events (TESAE)s
时间窗: up to 7 years
Serious adverse event data were collected after signing the informed consent until 30 days after the last study drug administration (end of safety follow-up)
Number of Participants With Abnormal Laboratory Parameters
时间窗: up to 7 years
- Above threshold of 10% and reported as TEAEs - any event (Grade 1-4)
Number of Participants With Treatment-emergent Adverse Events (TEAE)s
时间窗: up to 7 years
Adverse event data were collected after signing the informed consent until 30 days after the last study drug administration (end of safety follow-up)
次要结局
未报告次要终点
研究者
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