EUCTR2013-003990-89-FI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: 2016年2月29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
- 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
- •-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
- •-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
- •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
研究者
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