EUCTR2017-003150-16-DE进行中（未招募）1 期
Copanlisib and Rituximab in Marginal Zone Lymphoma Patients - COUP-1
niversity Hospital Ulm0 个研究点目标入组 30 人开始时间: 2018年6月20日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 30
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
- •Patients must have a proven pathological diagnosis of MZL, diagnosed by a reference pathology center.
- •Patients must meet the following inclusion criteria to be eligible for participation in this study:
- •– Confirmed CD20 positive de novo or relapsed MALT Lymphoma in need of treatment following or being not eligible for local therapy (including surgery, radiotherapy and antibiotics e.g. for H. pylori-positive gastric lymphoma arisen at any extranodal site)
- •– Confirmed CD20 positive de novo or relapsed splenic MZL in need of treatment following or not being eligible for local therapy (including surgery and antiviral therapy for Hepatitis C Virus)
- •– Confirmed CD20 positive de novo or relapsed nodal MZL in need of treatment following or not being eligible for local therapy (radiotherapy)
- •For nodal MZL and extragastric MALT lymphoma:
- •– At least one bi-dimensionally measurable lesion (= 1.5 cm in its largest dimension by CT scan or MRI). Please refer to Appendix C.
- •For splenic MZL, an enlarged spleen on CT scan and lymphoma cell infiltration has to be seen in bone marrow and/or peripheral blood. Please refer also to Appendix E.
- •At least one of the following criteria must be met:
- •– Bulky progressive or painful splenomegaly
- •– one of the following symptomatic/progressive cytopenias : Hb < 10 g/dL, or Plat < 80.000 /µL, or neutropenia < 1000 /µL, whatever the reason (autoimmune or hypersplenism or bone marrow infiltration)
- •– SMZL with concomitant hepatitis C infection which has not responded to or has relapsed after Interferon and/or Ribavirin and/or direct antiviral agents (patients positive for HCV antibody are eligible only if PCR is negative for HCV RNA).
- •– splenectomised patients with rapidly raising lymphocyte counts, development of lymphadenopathy or involvement of extranodal sites if not being eligible for local therapy
- •For gastric MALT lymphoma:
- •For gastric MALT lymphoma, the clinical evidence of the MZL as seen by gastroendoscopy is sufficient. There is no need to show a measurable lesion by CT scan or MRI. Please refer to Appendix D.
- •Inclusion is possible for patients with:
- •– H. pylori-negative disease de novo or following or being not eligible for local therapy (i.e., surgery, radiotherapy or antibiotics) or after systemic therapy.
- •- H. pylori-positive disease that has remained stable, progressed, or relapsed following antibiotic therapy.
- •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 18
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 18
排除标准
- •The presence of any of the following will exclude a subject from enrolment:
- •– ECOG performance status = 2
- •– History of a non-lymphoid malignancy except for the following: adequately treated local basal cell or squamous cell carcinoma of the skin, cervical carcinoma in situ, superficial bladder cancer, asymptomatic prostate cancer without known metastatic disease and with no requirement for therapy or requiring only hormonal therapy and with normal prostate specific antigen for =1 year prior to study enrolment visit, other Stage 1 or 2 cancer treated with a curative intent and currently in complete remission, for =3 years.
- •– Central nervous system lymphoma, leptomeningeal lymphoma, or histologic evidence of transformation to a high-grade or diffuse large B-cell lymphoma.
- •– Ongoing immunosuppressive therapy including corticosteroids (expection <4 weeks administered at a dose equivalent to = 40 mg/day prednisone is allowed)
- •– Evidence of ongoing systemic bacterial, fungal, or viral infection at the time of study enrolment visit
- •– Ongoing drug-induced liver injury, chronic active hepatitis B (HBV), alcoholic liver disease, non-alcoholic steatohepatitis, primary biliary cholangitis, extrahepatic obstruction caused by cholelithiasis, cirrhosis of the liver, or portal hypertension.
- •– Ongoing alcohol or drug addiction
- •– Breastfeeding or pregnancy
- •– Treatment with any other investigational agent within 30 days or within 5 x the half-life (t1/2) of the investigational product, whichever is longer, or participating in another trial within 30 days prior to entering this study
- •– Prior treatment with Copanlisib
- •– 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 arterial hypertension despite optimal medical management
- •– HbA1c> 8.5%
- •– Prior or ongoing clinically significant illness, medical condition, surgical history, physical finding, electrocardiogram (ECG) finding, or laboratory abnormality that, in the investigator’s opinion, could adversely affect the safety of the subject or impair the assessment of study results.
- •– History of anaphylaxis in association with previous administration of monoclonal antibodies.
- •– Vaccination with a live vaccine within 28 days prior to start of therapy
- •– 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
- •– History or concurrent interstitial lung disease of any severity and/or severely impaired lung function (as judged by the investigator).
研究者
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