EUCTR2014-001002-17-BE进行中（未招募）1 期
A prospective phase II study of bendamustine in patients aged over 60 years with classical Hodgkin lymphoma treated by prednisone, vinblastine, and doxorubicin - PVAB
YSARC0 个研究点目标入组 90 人开始时间: 2015年6月3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
- 90
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
- •Patients must satisfy all following criteria to be enrolled in the study:
- •Patient with a first diagnosis of classical Hodgkin lymphoma according to WHO criteria excluding nodular lymphocyte predominant subtype
- •Age of 61 years or older
- •No previous treatment for Hodgkin lymphoma
- •Ann Arbor stages:
- •- II with mediastinum/thorax =0.33 or extranodal localization and with B symptoms
- •Baseline 18-FDG PET scan (PET0) performed before any treatment with at least one hypermetabolic lesion
- •ECOG performance status 0-2
- •Adequate cardio-pulmonary function with LVEF = 50%
- •Adequate renal function with creatinine clearance = 40 mL/mn (MDRD formula)
- •For patients aged 70 years old and more, a Mini Nutritional Assessment (MNA) = 17
- •A minimum life expectancy of 3 months
- •Negative HIV, HBV (anti-HBc negativity) and HCV serologies tests = 30 days before inclusion (except after vaccination)
- •Having previously signed a written informed consent
- •The patient must be covered by a social security system, if applicable
- •Men patient must agree to use an adequate method of contraception during the study treatment and until 6 months after the end of the study treatment.
- •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 22
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 68
排除标准
- •Presence of any of the following will exclude a patient from enrollment:
- •Any other type of lymphoma including nodular lymphocyte predominant subtype
- •Any history of treated Hodgkin lymphoma
- •Contra-indication to any drug contained in the chemotherapy regimens
- •Any serious active disease (according to the investigator’s decision)
- •Poor hepatic function (total bilirubin level > 30 µmol/L or transaminases > 2.5 maximum normal level) unless these abnormalities are related to the lymphoma
- •Poor bone marrow reserve as defined by leukocytes < 2 G/L or platelets < 100 G/L, unless related to bone marrow infiltration
- •Any history of cancer during the last 3 years with the exception of non-melanoma skin tumors or stage 0 (in situ) cervical carcinoma. Patients previously diagnosed with prostate cancer are eligible if they fulfil all the followings:
- •(1) their disease was T1-T2a, N0, M0, with a Gleason score = 7, and a prostate specific antigen (PSA) = 10 ng/mL prior to initial therapy,
- •(2) they had definitive curative therapy (i.e. prostatectomy or radiotherapy) = 2 years before Day 1 of Cycle 1,
- •(3) at a minimum 2 years following therapy, they had no clinical evidence of prostate cancer and their PSA was undetectable if they underwent prostatectomy or < 1 ng/mL if they did not undergo prostatectomy
- •Severe metabolic disease interfering with normal application of protocol treatment as uncontrolled diabetes mellitus leading to impossibility to perform PET scan
- •Treatment with any investigational drug within 30 days before planned first cycle of chemotherapy and during the study
- •Adult under tutelage.
研究者
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