ACTRN12615000551594已完成2 期
A Phase II Study of Ibrutinib, Rituximab and mini-CHOP therapy in very elderly patients with newly diagnosed DLBC
Australasian Leukaemia and Lymphoma Group0 个研究点目标入组 80 人开始时间: 2015年5月29日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
入排标准
- 年龄范围
- 75 Years 至 o limit（—）
- 性别
- All
入选标准
- •1. Subject must be 75 years of age or older
- •2. No prior treatment for DLBCL excluding prednisone
- •3. Histologically confirmed de novo CD20+ DLBCL
- •4. Stage I bulky (largest dimension of lesion >/= 6cm), II, III or IV disease by the Ann Arbor Classification
- •5. At least 1 measurable site of disease according to the 2014 Recommendations for Initial Evaluation, Staging and Response Assessment of Hodgkin and Non-Hodgkin Lymphoma – the Lugano Classification. The site of disease must be greater than 1.5 cm in the long axis regardless of short axis measurement. An extranodal lesion should have a longest diameter of > 1cm.
- •6. Eastern Cooperative Oncology Group performance status score of 0, 1, or 2 (this can be as measured after any pre-phase prednisone)
- •7. LVEF within institutional normal limits, as determined by Gated Heart Pool Scan, or if not available, echocardiogram
- •8. Minimum life expectancy of 3 months
- •9. Haematology values must be within the following limits:
- •a. Absolute neutrophil count (ANC) >=1.0 x10^9/Lindependent of growth factor support
- •b. Platelets >=100x10^9/L or >=50x10^9/L if bone marrow involvement independent of transfusion support in either situation
- •10. Biochemical values within the following limits:
- •a. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <= 3 x upper limit of normal (ULN)
- •b. Total bilirubin <= 1.5 x ULN unless bilirubin rise is due to Gilbert’s syndrome or of non-hepatic origin
- •c. Creatinine Clearance (as measured by Cockroft Gault) >/= 40 mL/min/1.73m2
- •11. Each subject (or their legally acceptable representative) must sign an informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for the study and are willing to participate in the study.
- •12. 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.
排除标准
- •1. History of treated lymphoma of any subtype
- •2. CNS or meningeal involvement
- •3. Contraindication to any drug in the chemotherapy regimen
- •4. Serious active co-morbid disease according to the investigator’s decision
- •5. Poor renal function, defined as a Creatinine Clearance Rate (as measured by Cockcroft Gault) < 40 mL/min/1.73m2
- •6. Poor hepatic function, defined as Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) > 3 x upper limit of normal (ULN) and/or total bilirubin > 1.5 x ULN unless bilirubin rise is due to Gilbert’s syndrome or of non-hepatic origin
- •7. Poor bone-marrow reserve, defined as absolute neutrophil count (ANC) < 1.0x10^9/L independent of growth factor support and/or platelet count < 100x10^9/L or < 50x10^9/L if bone marrow involvement independent of transfusion support in either situation
- •8. History of malignancy during the past 3 years, with the exception of non-melanoma skin cancers or stage 0 (in situ) carcinoma.
- •9. Treatment with any investigational drug within 30 days before the planned first cycle of chemotherapy
- •10. Requires anticoagulation with warfarin or equivalent vitamin K antagonists
- •11. Requires dual antiplatelet therapy with aspirin and a P2Y12 antagonist
- •12. Requires treatment with strong CYP3A inhibitors
- •13. Requires treatment with fish oil
- •14. Prior anthracycline use >= 150 mg/m2
- •15. History of stroke or intracranial haemorrhage within 6 months of enrolment
- •16. Unable to swallow capsules or malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel, symptomatic inflammatory bowel disease or ulcerative colitis, or partial or complete bowel obstruction
- •17. Known bleeding disorders (e.g. von Willebrand’s disease)
- •18. Major surgery within 4 weeks of enrolment
- •19. 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
- •20. Clinically significant cardiovascular disease 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
- •21. Known history of human immunodeficiency virus (HIV) or active Hepatitis C Virus (HCV; RNA polymerase chain reaction [PCR]-positive) or active Hepatitis B Virus (HBV; DNA PCR-positive) infection. Only patients who are HBV surface antigen (HBVsAg) and/or HBV core antibody (HBVcAb) positive are required to undergo HBV DNA PCR testing. Subjects with PCR-negative HBV or who are HBV core antibody positive are permitted in the study but must be on HBV prophylaxis.
- •22. Any uncontrolled active systemic infection requiring intravenous (IV) antibiotics.
- •23. Vaccinated with live, attenuated vaccines within 4 weeks of enrolment.
研究者
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