EUCTR2014-001810-24-ES进行中（未招募）不适用
A PROSPECTIVE, OPEN-LABEL, MULTICENTER, RANDOMIZED PHASE III TRIAL TO COMPARE THE EFFICACY AND SAFETY OF A COMBINED REGIMEN OF OBINUTUZUMAB AND GDC-0199 (ABT-199) VERSUS OBINUTUZUMAB AND CHLORAMBUCIL IN PREVIOUSLY UNTREATED PATIENTS WITH CLL AND COEXISTING MEDICAL CONDITIONS - CLL14
Roche Farma, S.A, en nombre de F. Hoffmann-La Roche Ltd0 个研究点目标入组 432 人开始时间: 2015年2月9日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 432
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
- •- Documented previously untreated CLL according to the International Workshop on Chronic Lymphocytic Leukemia (IWCLL) criteria
- •- CLL requiring treatment according to IWCLL criteria
- •- Total Cumulative Illness Rating Scale (CIRS score) > 6
- •- Adequate marrow function independent of growth factor or transfusion support within 2 weeks of screening as per protocol, unless cytopenia is due to marrow involvement of CLL
- •- Adequate liver function
- •- Life expectancy > 6 months
- •- Agreement to use highly effective contraceptive methods per protocol
- •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 75
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 357
排除标准
- •- Transformation of CLL to aggressive Non-Hodgkin's lymphoma (Richters transformation or pro-lymphocytic leukemia)
- •- Known central nervous system involvement
- •- Patients with a history of confirmed progressive multifocal leukoencephalopathy (PML)
- •- An individual organ/ system impairment score of 4 as assessed by the CIRS definition limiting the ability to receive the treatment regimen of this trial with the exception of eyes, ears, nose, throat organ system
- •- Patients with uncontrolled autoimmune hemolytic anemia or immune thrombocytopenia
- •- Inadequate renal function
- •- History of prior malignancy, except for conditions as listed in the protocol if patients have recovered from the acute side effects incurred as a result of previous therapy
- •- Patients with active bacterial, viral, or fungal infection requiring systemic treatment within the last two months prior to registration
- •- History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies or known sensitivity or allergy to murine products
- •- Hypersensitivity to chlorambucil, obinutuzumab, or GDC-0199 or to any of the excipients
- •- Pregnant women and nursing mothers
- •- Positive test results for chronic HBV infection (defined as positive HBsAg serology) or positive test result for hepatitis C (hepatitis C virus [HCV] antibody serology testing)
- •- Patients with known infection with human immunodeficiency virus (HIV) or human T-cell leukemia virus-1 (HTLV-1)
- •- Requires the use of warfarin, marcumar, or phenprocoumon
- •- Received agents known to be strong CYP3A4 inhibitors or inducers within 7 days prior to the first dose of study drug
研究者
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