EUCTR2015-001487-19-AT进行中（未招募）1 期
Rituximab with or without Ibrutinib for untreated patients with advanced follicular lymphoma in need of therapy. A randomized, double-blinded, SAKK and NLG collaborative Phase II trial. - Protocol SAKK 35/14
Swiss Group For Clinical Cancer Research (SAKK)0 个研究点目标入组 190 人开始时间: 2018年9月24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
- 190
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
- •6.1.1 Written informed consent according to ICH/GCP guidelines
- •6.1.2 Histologically confirmed FL CD20+; grade 1, 2, 3a; stage III+IV; stage II not suitable for radiotherapy; all FLIPI
- •6.1.3 Tumor specimens (slides or block) available for pathological review
- •6.1.4 In need of systemic therapy (at least one of the following indications must be fulfilled):
- •? Symptomatic disease
- •? Bulky disease (= 6 cm)
- •? Steady, clinically significant progression over at least 3 months of any tumor lesion
- •? B-symptoms (weight loss > 10% in 6 months, drenching night sweats, fever > 38°C not due to infection)
- •? Anemia (hemoglobin < 100 g/L) or thrombocytopenia (platelets 50-100 x 109/L) due to lymphoma
- •6.1.5 At least one two-dimensionally measurable lesion with a longest diameter (LDi) = 15 mm or a measurable extranodal lesion with a LDi > 10 mm in contrast-enhanced 18F-FDG PET/CT* scan
- •6.1.6 At least one FDG-avid tumor lesion in contrast-enhanced 18F-FDG PET/CT* scan
- •6.1.7 Age 18-85 years
- •6.1.8 WHO performance status 0-2
- •6.1.9 Adequate bone marrow function:
- •? Absolute neutrophil count (ANC) > 1.0 x 109/L independent of growth factor support
- •? Platelets = 100 x 109/L or = 50 x 109/L if bone marrow involvement independent of transfusion support in either situation
- •6.1.10 Adequate hepatic function:
- •? Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) = 3 x upper limit of normal (ULN)
- •? Total bilirubin = 1.5 x ULN unless bilirubin rise is due to Gilbert’s syndrome or of non-hepatic origin
- •6.1.11 Adequate renal function:
- •? Serum creatinine = 2 x ULN and corrected calculated creatinine clearance = 40 mL/min/1.73m2.
- •6.1.12 Women of childbearing potential have a negative serum (beta-human chorionic gonadotropin [?-hCG]) or urine pregnancy test at Screening.
- •6.1.13 Women of childbearing potential and men who are sexually active must be practicing a highly effective method of birth control during and after the study consistent with local regulations regarding the use of birth control methods for subjects participating in clinical trials. Men must agree to not donate sperm during and after the study. For females and males, these restrictions apply for 12 months after the last dose of study drug.
- •6.1.14 Patient compliance and geographic proximity allow proper staging and follow-up.
- •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 76
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 114
排除标准
- •6.2.1 Tumor bulk requiring fast response
- •6.2.2 Known central nervous system lymphoma
- •6.2.3 Previous systemic FL therapies
- •6.2.4 Major surgery 4 weeks prior to randomization
- •6.2.5 Previous or concomitant malignancy diagnosed within 3 years with the exception of adequately treated cervical carcinoma in situ or localized non-melanoma skin cancer
- •6.2.6 History of stroke or intracranial hemorrhage within 6 months prior to randomization
- •6.2.7 Clinically significant cardiovascular diseases such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening, or any Class 3 (moderate) or Class 4 (severe) cardiac disease as defined by the New York Heart Association Functional Classification
- •6.2.8 Known history of human immunodeficiency virus (HIV) or active Hepatitis C Virus or active Hepatitis B Virus infection or any uncontrolled active systemic infection requiring intravenous (i.v.) antibiotics
- •6.2.9 Concomitant diseases that require anticoagulation with warfarin or equivalent vitamin K antagonists (eg. phenprocoumon), factor Xa inhibitors (e.g. rivaroxaban, apixaban), direct thrombin inhibitors (e.g. dabigatran) or platelet inhibitors/antiplatelet agents
- •6.2.10 Concomitant diseases that require treatment with strong or moderate CYP3A inhibitors, including St. John's wort (see http://medicine.iupui.edu and also chapter 9)
- •6.2.11 Any concomitant drugs contraindicated for use with the trial drugs according to the approved product information or known hypersensitivity to the trial drugs Ibrutinib/Placebo and Rituximab or to any of their components (including placebo)
- •6.2.12 Concurrent treatment with other experimental drugs or other anticancer therapy, treatment in a clinical trial within 30 days prior to trial entry
- •6.2.13 Vaccinated with live, attenuated vaccines 4 weeks prior to randomization
- •6.2.14 Any life-threatening illness, medical condition, or organ system dysfunction which, in the Investigator’s opinion, could compromise the subject’s safety, interfere with the absorption or metabolism of Ibrutinib capsules, or put the study outcomes at undue risk
- •6.2.15 Psychiatric disorder precluding understanding information of trial related topics, giving informed consent or interfering with compliance for oral drug intake
- •6.2.16 Women who are pregnant or breastfeeding
- •6.2.17 Patients regularly taking corticosteroids during the last 4 weeks, unless administered at a dose equivalent to Prednisone = 15 mg/day for indications other than lymphoma or lymphoma-related symptoms
研究者
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