CTIS2023-504653-12-00招募中1 期
A PROSPECTIVE, OPEN-LABEL, MULTICENTRE PHASE-II-TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF ZANUBRUTINIB (BGB-3111), A BTK INHIBI-TOR, PLUS TISLELIZUMAB (BGB-A317), A PD-1 INHIBITOR, WITH AND WITH-OUT SONROTOCLAX (BGB-11417), A BCL2 INHIBITOR, FOR TREATMENT OF PATIENTS WITH RICHTER TRANSFORMATION - CLL-RT1-Trial - CLL-RT1
niversity Of Cologne0 个研究点目标入组 85 人开始时间: 2023年9月14日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 85
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
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •Confirmed diagnosis of CLL according to iwCLL criteria (Hallek et al, 2018), Life expectancy = 3 months, Ability and willingness to provide written informed consent and to adhere to the study visit schedule and other protocol requirements, Confirmed histopathological diagnosis of RT (diffuse large B-cell lymphoma or Hodgkin's lymphoma [Hodgkin's lym-phoma only when not eligible for more intensive treatment]), Previously untreated RT or patients with objective response or non-tolerance to first-line RT treatment, Adequate bone marrow function as defined by: -Absolute neutrophil count (ANC) = 1000/mm3, except for patients with bone marrow involvement in which ANC must be = 500/mm3 -Platelet = 75,000/mm3, except for patients with bone marrow involvement in which the platelet count must be = 30,000/mm3, Creatinine clearance =30ml/min calculated according to the modified formula of Cockcroft and Gault or directly measured with 24hr urine collection or an equivalent method, Adequate liver function as indicated by a total bilirubin= 2 x, AST/ALT = 2.5 x the institu-tional ULN value, unless directly attributable to the patient’s CLL/RT or to Gilbert’s Syndrome, in which case a max. total bilirubin = 3 x and AST/ALT = 5 x the institutional ULN value are required. (For patients who start study treatment with elevated liver enzymes due to CLL/RT or Gilbert’s syndrome, toxicity and AE reporting will follow CTCAE grading once these values further increase. E.g. if a patient starts with a bilirubin value of 2.0 mg/dl, which rises to 3.0 mg/dl after one cycle, this should be reported as grade 2 bilirubinemia (see CTCAE v5)), Negative serological testing for hepatitis B (HBsAg negative and anti-HBc negative; patients positive for anti-HBc may be included if PCR for HBV DNA is negative and HBV-DNA PCR is performed every two months until 2 months after last dose of zanubrutinib), negative testing for hepatitis-C RNA and negative HIV test within 6 weeks prior to registration, Age at least 18 years, ECOG performance status 0-2, ECOG 3 is only permitted if related to CLL or RT (e.g. due to anaemia or severe constitutional symptoms)
排除标准
- •Patients who did not respond to previous line of RT therapy (i.e. primary progressive patients) ( In cases with urgent need for treatment, a prephase treatment with steroids, vincristine (up to 2 mg IV) or cyclo-phosphamide (up to 200 mg2 daily for max 3 days) can be administered at the discretion of the treating physician prior to enrolment or start of study medication. ), Requirement of therapy with phenprocoumon or other vitamin K antagonists., Known active infection with HIV, or serologic status reflecting active hepatitis B or C infection as follows: -Presence of hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb). Patients with presence of HBcAb, but absence of HBsAg, are eligible if hepatitis B virus (HBV) DNA is undetectable (< 20 IU), and if they are willing to under-go monitoring every 4 weeks for HBV reactivation. -Presence of hepatitis C virus (HCV) antibody. Patients with presence of HCV anti-body are eligible if HCV RNA is undetectable, Major surgery within 4 weeks of the first dose of study drug., Any uncontrolled or clinically significant cardiovascular disease including the following: -Myocardial infarction within 6 months before screening -Unstable angina within 3 months before screening -New York Heart Association class III or IV congestive heart failure -History of clinically significant arrhythmias (eg, sustained ventricular tachycardia, ven-tricular fibrillation, torsades de pointes), History of severe bleeding disorder such as hemophilia A, hemophilia B, von Willebrand disease, or history of spontaneous bleeding requiring blood transfusion or other medical intervention, History of stroke or intracranial hemorrhage within 6 months before first dose of study drug, Severe or debilitating pulmonary disease, Unable to swallow capsules or disease significantly affecting gastrointestinal function such as malabsorption syndrome, resection of the stomach or small bowel, bariatric sur-gery procedures, symptomatic inflammatory bowel disease, or partial or complete bowel obstruction, Use of investigational agents, e.g. monoclonal antibodies or other experimental drugs within clinical trials, which might interfere with the study drug within 28 days (or 5 times half-life [t1/2] of the compound, whichever is longer) prior to registration, Known hypersensitivity to tislelizumab, zanubrutinib, sonrotoclax or any of the excipients, Patients with more than one prior line of RT therapy, Pregnant women and nursing mothers (a negative pregnancy test is required for all women of childbearing potential within 7 days before start of treatment), Fertile men or women of childbearing potential unless: -surgically sterile or = 2 years after the onset of menopause, or -willing to use two methods of reliable contraception including one highly effective contra-ceptive method (Pearl Index <1) and one additional effective (barrier) method during study treatment and for 12 months after the end of study treatment., Vaccination with a live vaccine <28 days prior to randomization, Legal incapacity, Prisoners or subjects who are institutionalized by regulatory or court order, Persons who are in dependence to the sponsor or an investigator, Allogenic stem cell transplantation within the last 100 days or signs of active GVHD after prior allogeneic stem cell transplantation within any time, Patients with confirmed PML, Uncontrolled autoimmune condition, Malignancies other than CLL currently requiring systemic therapies (u
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