EUCTR2014-001810-24-AT进行中（未招募）1 期
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
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 445
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 infections requiring IV treatment (grade 3 or 4) within the last two months prior to enrollment
- •- 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 Venetoclax 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 and moderate CYP3A4 inhibitors or inducers within 7 days prior to the first dose of study drug
研究者
相似试验
招募中
1 期
Comparison of a fixed-duration treatment of acalabrutinib, venetoclax and obinutuzumab to a treatment of venetoclax and obinutuzumab in patients with high risk chronic lymphocytic leukemiaEUCTR2020-004360-26-ATGerman CLL Study Group (University of Cologne)178
进行中（未招募）
1 期
A Study to Compare the Efficacy and Safety of Obinutuzumab + GDC-0199 versus Obinutuzumab + Chlorambucil in Patients with Chronic Lymphocytic LeukemiaEUCTR2014-001810-24-PLF. Hoffmann-La Roche Ltd445
进行中（未招募）
1 期
A Study to Compare the Efficacy and Safety of Obinutuzumab + GDC-0199 versus Obinutuzumab + Chlorambucil in Patients with Chronic Lymphocytic LeukemiaEUCTR2014-001810-24-DKF. Hoffmann-La Roche Ltd445
进行中（未招募）
不适用
A Study to Compare the Efficacy and Safety of Obinutuzumab + GDC-0199 versus Obinutuzumab + Chlorambucil in Patients with Chronic Lymphocytic LeukemiaEUCTR2014-001810-24-ESRoche Farma, S.A, en nombre de F. Hoffmann-La Roche Ltd432
进行中（未招募）
1 期
Comparison of a fixed-duration treatment of acalabrutinib, venetoclax and obinutuzumab to a treatment of venetoclax and obinutuzumab in patients with high risk chronic lymphocytic leukemiaPatients with previously untreated chronic lymphocytic leukemia with treatment requiring disease and at least one out of three risk factors (17p-deletion, TP53 mutation or Complex karyotype).EUCTR2020-004360-26-DEGerman CLL Study Group (University of Cologne)178