EUCTR2015-001088-38-GB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 (LPL/WM)
- •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-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 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 Screening.
- •- Women of childbearing potential (WOCBP) and men must agree to use effective contraception when sexually active. This applies for the time period between signing of the informed consent form and 12 months (for WOCBP) and 6 months (for men) after the last administration of study treatment. The use of condoms by male patients is required unless the female partner is permanently sterile.
- •- 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 206
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 206
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 date of rituximab administration, including rituximab maintenance).
- •- 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.
- •- HbA1c > 8.5% at Screening.
- •- 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.
- •- Previous or concurrent history of malignancies other than indolent non-
- •Hodgkin's lymphoma within 5 years prior to study treatment except for
- •curatively treated: Cervical carcinoma in situ, Non-melanoma skin
- •cancer, Superficial bladder cancer (Ta [non-invasive tumor], Tis
- •[carcinoma in situ] and T1 [tumor invades lamina propria]), Localized
- •prostate cancer
- •- Congestive heart failure > New York Heart Association (NYHA) class 2.
- •- Unstable angina (angina symptoms at rest), new-onset angina (begun
- •within the last 3 months). Myocardial infarction less than 6 months
- •before start of test drug.
- •- Uncontrolled hypertension despite optimal medical management (per
- •investigator's assessment).
- •- Arterial or venous thrombotic or embolic events such as
- •cerebrovascular accident (including transient ischemic attacks), deep
- •vein thrombosis or pulmonary embolism within 3 months before the
- •start of study medication.
- •- Non-healing wound, ulcer, or bone fracture.
- •- Active, clinically serious infections (> CTCAE grade 2).
- •- Patients with seizure disorder requiring medication
- •- Patients with evidence or history of bleeding diathesis. Any
- •hemorrhage or bleeding event = CTCAE Grade 3 within 4 weeks of start
- •of study medication.
- •- Known hypersensitivity to any of the study drugs, study drug classes,
- •or excipients in the formulation.
- •- Proteinuria of CTCAE Grade 3 or estimated by urine protein : creatinine
- •ratio > 3.5 (> 396 mg/mmol)on a random urine sample
- •- Unresolved toxicity higher than NCI-CTCAE grade 1 attributed to any
- •prior therapy/procedure excluding alopecia.
- •- Concurrent diagnosis of pheochromocytoma.
- •- Pregnant or breast-feeding patients. Women of childbearing potential
- •must have a pregnancy test performed a maximum of 7 days before start
- •of treatment, and a negative result must be documented before start of
- •- Substance abuse, medical, psychological or social conditions that may
- •interfere with the patient's participation in the study or evaluation of the
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研究者
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