An Open-label, Single-arm Phase II Study in Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL) to Evaluate Efficacy and Safety of Treatment With Single Agent Copanlisib and the Impact of Biomarkers Thereupon.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 67
- 主要终点
- ORR by DLBCL/COO Subtype Based on Investigator Assessment
研究概览
简要总结
To assess the potential efficacy (in terms of objective response) of single agent copanlisib in patients with relapsed or refractory Diffuse large B-cell lymphoma (DLBCL) and assess the relationship between efficacy and a potentially predictive biomarker
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
- •Diagnosis of Diffuse large B-cell lymphoma (DLBCL) (de novo or DLBCL transformed from follicular lymphoma on the basis of a tissue biopsy).
- •Received at least one prior therapy for aggressive Non-Hodgkin's Lymphoma (NHL) (DLBCL).
- •Received CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone) + rituximab or equivalent regimen.
- •Patients must have measurable disease.
- •Not eligible or not willing to receive the high-dose (myeloablative) chemotherapy (HDC) and stem cell transplant (SCT).
- •A fresh tumor biopsy collected during screening and /or archival tumor tissue collected after the last relapse/disease progression.
- •Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤
- •Left ventricular ejection fraction (LVEF) ≥ the lower limit of normal (LLN) for the Institution. (as per local standard of care) as measured by echocardiogram (ECHO) or Multiple gated acquisition (MUGA) scan.
- •Adequate bone marrow, liver and renal function.
排除标准
- •Any of the following as the only site(s) of disease: palpable lymph nodes not visible on imaging studies, skin lesions, or bone marrow involvement only.
- •Active CTCAE (Common Terminology Criteria for Adverse Events) Grade 3/4 infection.
- •Current central nervous system (CNS) involvement by lymphoma.
- •Unstable angina (angina symptoms at rest), new-onset angina (begun within the last 3 months). Myocardial infarction within the past 6 months before start of study treatment.
- •Uncontrolled arterial hypertension despite optimal medical management (per investigator's opinion).
- •Type I or II diabetes mellitus with HbA1c > 8.5% at Screening.
- •New York Heart Association (NYHA) class III or IV heart disease.
- •History or concurrent condition of interstitial lung disease of any severity and/or severely impaired lung function (as judged by the investigator).
- •Patients who previously received therapy with copanlisib or other PI3K inhibitors are not eligible for enrollment.
研究组 & 干预措施
Copanlisib (Aliqopa, BAY80-6946)
Copanlisib (Aliqopa, BAY80-6946) solution for IV infusion (test drug/investigational medicinal product)
干预措施: Copanlisib (Aliqopa, BAY80-6946) (Drug)
结局指标
主要结局
ORR by DLBCL/COO Subtype Based on Investigator Assessment
时间窗: From start of study treatment assessed up to 24 weeks after the last participant fully evaluable for the primary endpoint started treatment (about 12 months)
The objective response rate (ORR) was defined as the percentage of participants who had at least one post-baseline overall response of complete response (CR) or partial response (PR) during study conduct according to the criteria defined by the Lugano Classification, 2014 and assessed by CT/MRI/PET-CT. The primary efficacy overall response assessment was based on investigator assessment of response.
Objective Response Rate (ORR) in Total Population Based on Investigator Assessment
时间窗: From start of study treatment assessed up to 24 weeks after the last participant fully evaluable for the primary endpoint started treatment (about 12 months)
The objective response rate (ORR) was defined as the percentage of participants who had at least one post-baseline overall response of complete response (CR) or partial response (PR) during study conduct according to the criteria defined by the Lugano Classification, 2014 and assessed by CT/MRI/PET-CT. The primary efficacy overall response assessment was based on investigator assessment of response.
ORR by CD79b Status Based on Investigator Assessment
时间窗: From start of study treatment assessed up to 24 weeks after the last participant fully evaluable for the primary endpoint started treatment (about 12 months)
The objective response rate (ORR) was defined as the percentage of participants who had at least one post-baseline overall response of complete response (CR) or partial response (PR) during study conduct according to the criteria defined by the Lugano Classification, 2014 and assessed by CT/MRI/PET-CT. The primary efficacy overall response assessment was based on investigator assessment of response.
次要结局
- OS by DLBCL/COO Subtype(From start of study treatment assessed up to 2 years after the last participant's first treatment or the last participant dies, whichever occurs first)
- DOR by DLBCL/COO Subtype(From start of study treatment assessed up to 2 years after the last participant's first treatment or the last participant dies, whichever occurs first)
- Disease Control Rate (DCR) in Total Population(From start of study treatment assessed up to 2 years after the last participant's first treatment or the last participant dies, whichever occurs first)
- DCR by CD79b Status(From start of study treatment assessed up to 2 years after the last participant's first treatment or the last participant dies, whichever occurs first)
- DCR by DLBCL/COO Subtype(From start of study treatment assessed up to 2 years after the last participant's first treatment or the last participant dies, whichever occurs first)
- DOR by CD79b Status(From start of study treatment assessed up to 2 years after the last participant's first treatment or the last participant dies, whichever occurs first)
- PFS by CD79b Status(From start of study treatment assessed up to 2 years after the last participant's first treatment or the last participant dies, whichever occurs first)
- OS by CD79b Status(From start of study treatment assessed up to 2 years after the last participant's first treatment or the last participant dies, whichever occurs first)
- Duration of Stable Disease (DOSD) in Total Population(From start of study treatment assessed up to 2 years after the last participant's first treatment or the last participant dies, whichever occurs first)
- Duration of Response (DOR) in Total Population(From start of study treatment assessed up to 2 years after the last participant's first treatment or the last participant dies, whichever occurs first)
- Progression-free Survival (PFS) in Total Population(From start of study treatment assessed up to 2 years after the last participant's first treatment or the last participant dies, whichever occurs first)
- PFS by DLBCL/COO Subtype(From start of study treatment assessed up to 2 years after the last participant's first treatment or the last participant dies, whichever occurs first)
- Overall Survival (OS) in Total Population(From start of study treatment assessed up to 2 years after the last participant's first treatment or the last participant dies, whichever occurs first)
- Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)(From start of test drug to 30 days after the last test drug intake, assessed up to 2 years after the last participant's first treatment or the last participant dies (whichever occurs first), with an average of 15 weeks for individual participant)