EUCTR2015-001088-38-DE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）
- 发起方
- Bayer AG
- 入组人数
- 520
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
- 性别
- All
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 study entry
- •o Lymphoplasmacytic lymphoma/ Waldenström macroglobulinemia
- •o Marginal zone lymphoma (MZL) (splenic, nodal, or extra-nodal)
- •- Patients must have relapsed (recurrence after complete response or
- •presented progression after partial response) or progressed after at
- •least one but at most three prior lines of therapy, including rituximab,
- •and/or rituximab biosimilars, and/or anti-CD20 monoclonal antibody
- •(e.g. obinutuzumab)-based immunochemotherapy and alkylating agents (if given
- •concomitantly is considered one line of therapy). A previous regimen is defined as one of
- •the following: at least 2 months of single-agent therapy (less than 2
- •months of therapy with single agent rituximab, or rituximab biosimilars, or anti-CD20 monoclonal antibody can be considered a previous regimen in the case the patient responded to it); at least 2
- •consecutive cycles of polychemotherapy; autologous transplant;
- •radioimmunotherapy. Previous exposure to other PI3K inhibitors (except
- •copanlisib) is acceptable provided there is no resistance (resistance
- •defined as no response (response defined as partial response [PR] or
- •complete response [CR]) at any time during therapy, or PD after any
- •response (PR/CR) or after stable disease within 6 months from the end
- •of the therapy with a PI3K inhibitor.
- •- Non-WM patients must have at least one bi-dimensionally measurable
- •lesion (that has not been previously irradiated) according to the Lugano
- •Classification. For patients with splenic MZL this requirement may be
- •restricted to splenomegaly alone since that is usually the only
- •manifestation of measurable disease.
- •- 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 and
- •positive immunofixation test.
- •- 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
- •- 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 260
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 260
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, or rituximab biosimilars, or anti-CD20 monoclonal antibody (e.g. obinutuzumab)
- •resistance at any line of therapy (resistance defined as lack
- •of response, or progression within 6 months of the last date of rituximab, or rituximab biosimilars, or anti-CD20 monoclonal antibody administration, including maintenance with these drugs ).
- •- HbA1c > 8.5% 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.
- •- Known history of human immunodeficiency virus (HIV) infection.
- •- Hepatitis B (HBV) or C (HCV) infection. Patients positive for hepatitis B
- •surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) will be
- •eligible if they are negative for HBV-DNA, these patients should receive
- •prophylactic antiviral therapy as per rituximab label. Patients positive
- •for anti-HCV antibody will be eligible if they are negative for HCV-RNA.
- •- Cytomegalovirus (CMV) infection. Patients who are CMV PCR positive at
- •baseline will not be eligible. CMV PCR test is considered positive if, the
- •result can be interpreted as a CMV viremia according to local SOC.
- •- Congestive heart failure > New York Heart Association (NYHA) class 2.
- •- Uncontrolled hypertension despite optimal medical management (per
- •investigator's assessment).
研究者
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