EUCTR2013-003990-89-DE进行中（未招募）1 期
Brentuximab vedotin or B-CAP in the treatment of older patients with newly diagnosed classical Hodgkin Lymphoma – a GHSG-NLG Intergroup Phase II trial –
niversity of Cologne0 个研究点目标入组 70 人开始时间: 2015年2月2日最近更新:
适应症
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
- 70
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
- •B-CAP group:
- •-Histologically proven classical Hodgkin lymphoma
- •-First diagnosis, no previous treatment except prephase as outlined
- •-Age: 60 years or older
- •-Advanced stages: Stage IIB with large mediastinal mass and/or extranodal lesions, stage III or IV disease
- •-ECOG performance status = 2 or = 3 if due to HL
- •-CIRS-G score of = 6 and = 3 per organ system (except score 4 for eye, ear, nose and throat)
- •-Negative HIV test
- •-Screening laboratory values must meet the following criteria: Hemoglobin =8.0 g/dl, WBC =1500/µl; neutrophils =1500/µl; platelets =75,000/µl (Unless due to HL) Alkaline phosphatase <3 ULN, AST or ALT <3 ULN, serum total bilirubin =1.5 ULN (unless diagnosed with Gilbert’s Syndrome)* INR 2 and an aPTT 2 ULN unless due to anticoagulation Creatinine clearance > 40 ml/min as estimated by the Cockroft-Gault formula*
- •-Life expectancy > 3 months
- •Brentuximab vedotin single agent group:
- •-Histologically proven classical Hodgkin lymphoma
- •-First diagnosis, no previous treatment
- •-Age: 60 years or older stage IA to IVB
- •-CIRS-G score of = 7 or 4 in one organ system (except score 4 for eye, ear, nose and throat)
- •-Patients not eligible to curative poly-chemotherapy at the investigators judgment
- •-Negative HIV test
- •-Screening laboratory values must meet the following criteria: Hemoglobin =8.0 g/dl, WBC =1500/µl; neutrophils =1500/µl; platelets =75,000/µl (Unless due to HL) Alkaline phosphatase <3 ULN, AST or ALT <3 ULN, serum total bilirubin =1.5 ULN (unless diagnosed with Gilbert’s Syndrome)* INR 2 and an aPTT 2 ULN unless due to anticoagulation Creatinine clearance > 40 ml/min as estimated by the Cockroft-Gault formula*
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •B-CAP group:
- •-Composite lymphoma or nodular lymphocyte- predominant Hodgkin lymphoma (NLPHL)
- •-Prior chemotherapy or radiation for HL except prephase as outlined in the protocol
- •-Prior chemotherapy containing anthracyclines
- •-Concurrent disease which precludes protocol treatment, in particular the following conditions: Chronic obstructive pulmonary disease (requiring = 2 inpatient treatments due to exacerbation within 1 year); History of myocardial infarction = 6 months prior to first dose of study drug; Symptomatic ischemic heart disease, ongoing arrhythmias of Grade > 2, or any other cardiac condition (e.g. pericardial effusion restrictive cardiomyopathy) within 6 months prior to first dose of study drug. Chronic stable atrial fibrillation on stable anticoagulant therapy is allowed; Heart failure = NYHA II and/or EF <50% (MUGA scan or echocardiography); Uncontrolled hypertension despite appropriate medication; Uncontrolled active infection; Chronic active or persisting (positive PCR) hepatitis B and/or hepatitis C
- •-Ongoing long-term (i.e. >6 months) ingestion of corticosteroids (e.g. for chronic polyarthritis) or antineoplastic drugs (e.g. methotrexate)
- •-Peripheral neuropathy greater than CTC Grade 1
- •-Patient’s lack of accountability, inability to appreciate the nature, meaning and consequences of the trial and to formulate his/her own wishes correspondingly
- •-Non-compliance General intolerance of any protocol medication Patients who have a relationship of dependence or
- •employer-employee relationship to the sponsor or the investigator
- •-Committal to an institution on judicial or official order Participation in another interventional trial that could interact with this trial
- •Brentuximab vedotin single agent group:
- •-Composite lymphoma or nodular lymphocyte- predominant Hodgkin lymphoma (NLPHL)
- •-Prior chemotherapy or radiation for HL except prephase as outlined in the protocol
- •-Ongoing long-term (i.e. >6 months) ingestion of corticosteroids (e.g. for chronic polyarthritis) or antineoplastic drugs (e.g. methotrexate)
- •-Peripheral neuropathy greater than CTC Grade 1
- •-Patient’s lack of accountability, inability to appreciate the nature, meaning and consequences of the trial and to formulate his/her own wishes correspondingly
- •-Non-compliance General intolerance of any protocol medication Patients who have a relationship of dependence or employer-employee relationship to the sponsor or the investigator
- •-Committal to an institution on judicial or official order
- •-Participation in another interventional trial that could interact with this trial
研究者
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