EUCTR2015-001088-38-FR进行中（未招募）1 期
A Phase III, randomized, double-blind, controlled, multicenter study of intravenous PI3K inhibitor copanlisib in combination with standard immunochemotherapy versus standard immunochemotherapy in patients with relapsed indolent non-Hodgkin’s lymphoma (iNHL) - CHRONOS-4 - Phase III study of copanlisib with standard immunochemotherapy in relapsed iNH
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 700
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •Main criteria for inclusion:
- •- Histologically confirmed diagnosis of CD20 positive iNHL with histological subtype limited to:
- •o Follicular lymphoma (FL) G1, G2, or G3a
- •o Small lymphocytic lymphoma (SLL) with absolute lymphocyte count <5x109/L at the time of diagnosis and at study entry
- •o Lymphoplasmacytic lymphoma/Waldenström macroglobulinemia (LPL/WM)
- •o Marginal zone lymphoma (MZL) (splenic, nodal, or extra-nodal)
- •- Patients must have relapsed after at least 1 prior line of therapy, including rituximab and alkylating agents. A previous regimen is defined as one of the following: at least 2 months of single-agent therapy; at least 2 consecutive cycles of polychemotherapy; autologous transplant; radioimmunotherapy. Previous exposure to PI3K inhibitors is acceptable provided there is no resistance (treatment stopped for other reasons than progressive disease).
- •- Non-WM patients must have at least one bi-dimensionally measurable lesion (that has not been previously irradiated) according to 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.
- •- Male or female patients = 18 years of age.
- •- Eastern Cooperative Oncology Group (ECOG) performance status = 2.
- •- Life expectancy of at least 3 months.
- •- Availability of fresh tumor tissue and/or archival tumor tissue at Screening.
- •- Adequate baseline laboratory values as assessed within 7 days before starting study treatment.
- •- Left ventricular ejection fraction = 50%.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 600
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 100
排除标准
- •Main criteria for exclusion:
- •- Histologically confirmed diagnosis of follicular lymphoma (FL) grade 3b or transformed disease, or chronic lymphocytic leukemia. In patients with clinical suspicion of transformed disease, a fresh biopsy is recommended.
- •- Rituximab resistance at any line of therapy (resistance defined as lack of response, or progression within 6 months of the last course of treatment with a rituximab containing regimen).
- •- Type I or II diabetes mellitus with HbA1c > 8.5% or fasting plasma glucose > 160 mg/dL at Screening.
- •- History or concurrent condition of interstitial lung disease and/or severely impaired lung function (as judged by the investigator).
- •- Known lymphomatous involvement of the central nervous system.
- •- Human immunodeficiency virus (HIV) infection.
- •- Hepatitis B (HBV) and C (HCV) infection. Patients with serologic markers of HBV immunization due to vaccination (HBsAg negative, Anti-HBc negative and Anti-HBs positive) will be eligible.
- •- Congestive heart failure > New York Heart Association (NYHA) class 2.
- •- Uncontrolled hypertension (systolic blood pressure > 150 mmHg or
- •diastolic pressure > 90 mmHg despite optimal medical management).
研究者
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