EUCTR2013-004394-27-GB进行中（未招募）1 期
Phase III study comparing R-CODOX-M/R-IVAC versus dose-adjusted EPOCH-R (DA-EPOCH-R) for patients with newly diagnosed high risk Burkitt lymphoma - HOVON 127 B
HOVON Foundation0 个研究点目标入组 260 人开始时间: 2018年6月25日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 260
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
- •First diagnosis of high risk Burkitt lymphoma (sporadic and HIV associated), histologically confirmed according to the WHO classification 2016;
- •High risk disease; i.e. any of following: elevated LDH, WHO performance status = 2 (appendix C of protocol), Ann Arbor stage III or IV (Appendix A of protocol), tumour mass = 10 cm;
- •Age 18-75 years inclusive;
- •WHO performance status (PS) 0-3, WHO PS 4 only if disease related (Appendix C of protocol);
- •Written informed consent.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 45
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
排除标准
- •All histopathological diagnoses other than Burkitt lymphoma according to the WHO classification 2016, irrespective of the presence of a MYC rearrangement;
- •Patients with endemic Burkitt lymphoma;
- •Patients with low risk Burkitt lymphoma (i.e. all of following: normal LDH, WHO performance status 0 or 1 (appendix C of protocol), Ann Arbor stage I or II (Appendix A of protocol), no tumour mass = 10 cm);
- •Patients with CNS localization of Burkitt lymphoma;
- •Prior treatment other than local radiation (max. 10 Gy) or short course (max 7 days) of steroids = 1 mg/kg for acute symptoms;
- •Creatinine clearance < 50 ml/min unless lymphoma related;
- •Inadequate hepatic function: bilirubin > 2.5 * ULN (total) except patients with Gilbert’s syndrome as defined by > 80% unconjugated;
- •Inadequate hematological function ANC < 1x109/l and platelets < 75x109 /l unless lymphoma related;
- •Severe pulmonary dysfunction (CTCAE grade 3-4, appendix D of protocol);
- •Severe neurological or psychiatric disease;
- •Active symptomatic ischemic heart disease, myocardial infarction, or congestive heart failure within the past year. If an ultrasound or MUGA scan is obtained the LVEF should exceed 45%;
- •All men and all women of child-bearing potential not willing or able to use an acceptable method of birth control for the duration of the study and one year beyond treatment completion;
- •Female subject pregnant or breast-feeding;
- •History of a prior invasive malignancy in the past 5 years with the exception of basal carcinoma of the skin or stage 0 cervical carcinoma;
- •Serious concomitant medical illnesses that would jeopardize the patient's ability to receive the regimen with reasonable safety, including active hepatitis B (HBV, see also paragraph 9.3) or hepatitis C (HCV) infection;
- •Current participation in another clinical trial if interfering with HO127;
- •Any psychological, familial, sociological and geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
研究者
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