CTIS2022-501808-96-00招募中1 期
Venetoclax in combination with the BTK inhibitor Ibrutinib and Rituximab or conventional chemotherapy (Bendamustine) and Ibrutinib and Rituximab in patients with treatment naive Mantle Cell Lymphoma not eligible for high dose therapy - 20-01434
niversitatsmedizin der Johannes Gutenberg-Universitat Mainz KöR0 个研究点目标入组 200 人开始时间: 2023年10月10日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •Histologically confirmed diagnosis of MCL according to WHO classification, Creatinine = 2 mg/dL or eGFR = 50 mL/min, Written informed consent form according to ICH/EU GCP and national regulations, Sexually active men with female partners of child-bearing potential potential must agree to use highly effective contraceptives, previously untreated stage II-IV (Ann Arbor), = 60 years and not suitable for autologous SCT, At least 1 measurable lesion; in case of bone marrow infiltration only, bone marrow aspiration and biopsy is mandatory for all staging evaluations., ECOG performance status = 2, Absolute neutrophil count (ANC) = 1000 cells/µL, Platelets =75.000 cells/µL, Transaminases (AST and ALT) =3 x ULN, Total bilirubin = 2 x ULN unless other reason known (Gilbert- Meulengracht-Syndrome)
排除标准
- •Major surgery within 4 weeks prior to first dose, Pulmonary (e.g. chronic lung disease with hypoxemia, e.g. DLCO = 65% or FEV1 = 65%), Endocrinological (e.g. severe, not sufficiently controlled diabetes mellitus), Patients with unresolved hepatitis B or C infection or known HIV positive infection (mandatory test) Concomitant or previous malignancies within the last 3 years other than basal cell skin cancer, Prostate cancer in remission with PSA within normal range or in situ uterine cervix cancer, Requires anticoagulation with warfarin or equivalent vitamin K antagonists (e.g. phenprocoumon), History of stroke or intracranial hemorrhage within 6 months prior to first dose, Treatment with strong or moderate CYP3A4/5 inhibitors/inducers within 7 days before first dose and during Venetoclax and Ibrutinib intake, Any life-threatening illness, medical condition, or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety, interfere with the absorption or metabolism of Ibrutinib capsules, or put the study outcomes at undue risk, Vaccinated with live, attenuated vaccines within 4 weeks prior to first dose, Known CNS involvement of MCL, Known bleeding disorder (e.g. von Willebrand disease; hemophilia) Serious concomitant disease interfering with a regular therapy according to the study protocol, Cardiac (Clinically significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of Screening, or any Class 3 (moderate) or Class 4 (severe) cardiac disease as defined by the New York Heart Association Functional Classification or LVEF below LLN)
研究者
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