EUCTR2014-004780-21-DE进行中（未招募）1 期
GOAL trial: Rescue treatment with the monoclonal anti CD20-antibody Obinutuzumab (GA101) in combination with PixantrOne for the treatment of patients with relapsed Aggressive B-cell Lymphoma - GOA
niversity Medical Center of the Johannes Gutenberg0 个研究点目标入组 70 人开始时间: 2015年4月28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
- •-Patients aged = 18 years
- •-Histologically proven diagnosis of diffuse large cell B-cell lymphoma, follicular lymphoma IIIB or transformed
- •indolent lymphoma according to the World Health Organization classification (central pathology review)
- •-Relapsed disease
- •-Eastern Cooperative Oncology Group [ECOG] performance Status =2, unless tumor associated
- •-Adequate cardiac reserve: Serum Troponin level must be consistent with no significant acute or chronic myocardial damage and there should be no evidence of symptomatic disease
- •-No curative option available
- •-At least 1 measurable tumor mass (>1.5 cm x >1.0 cm) or bone marrow infiltration
- •-Adequate bone marrow reserve: Platelets of at least 100.000/µl, absolute neutrophil count of at least 1000/µl.
- •Adequate hepatic and renal function: Alanine aminotransferase <2.5 x upper limit of normal (ULN); Aspartate
- •aminotransferase <2.5 x ULN, total bilirubin <1.5 x ULN
- •-No active Hepatitis B or C or HIV-infection
- •-Measured or calculated creatinine clearance >30 mL/min
- •-Fresh tumor biopsy or archived tissue available
- •-Ability of patients to understand nature, importance and individual consequences of clinical trial.
- •-Signed informed consent
- •-Women post-menopausal for more than two years can participate in the trial. Women with childbearing
- •potential can only participate, if they are surgically sterile or a negative pregnancy test (serum or urine) is
- •available before trial and they are willing to practice a highly effective and medically accepted contraception
- •method during trial and for a period of 18 months post-treatment. Reliable contraception comprises systematic
- •contraceptives (oral, implant, injection) or diaphragm / condoms / intrauterine devices (IUP) with spermicide.
- •-Male patients are advised to use contraceptive methods (preferably barrier) during treatment and for a period
- •of 6 months post-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 70
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 70
排除标准
- •-Lymphoma other than DLBCL, FL IIIB, transformed indolent NHL
- •-CNS involvement (brain MRI is required only in cases of clinically suspicious involvement)
- •-Pregnant or breast-feeding women
- •-Severe concomitant disease (e.g. uncontrolled arterial hypertension, heart failure (NYHA III-IV), uncontrolled
- •diabetes mellitus, pulmonary fibrosis, uncontrolled hyperlipoproteinaemia)
- •-Myocardial infarction within the last 6 months
- •-Active uncontrolled infections including HIV-positivity, active Hepatitis B or C
- •-Vaccination with live vaccine within last 4 weeks
- •-Mental status precluding patient’s compliance
- •-Known CD20 negativity
- •-Diagnosed or treated for a malignancy other than NHL except: adequately treated non-melanoma skin cancer,
- •curatively treated in-situ cancer of the cervix, DCIS of the breast, or other solid tumors curatively treated with
- •no evidence of disease for >3 years, or prostate cancer with a life expectancy of more than 2 years
- •-Treatment with any approved anticancer agent within last 2 weeks. Any agents must have been stopped at
- •least 2 weeks prior to day 1 of GOAL treatment and all treatment related adverse events must have returned
- •to Grade 1.
- •-Prior exposition to Obinutuzumab or Pixantrone
- •-History of hypersensitivity to medicinal products with similar chemical structure as the trial medication
- •-Active participation in other interventional clinical trials during the present clinical trial or within the last 2
- •weeks prior to treatment initiation. Concurrent participation in non-treatment studies is not excluded
- •-Medical or psychological conditions that would jeopardize an adequate and orderly completion of the trial.
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