JPRN-jRCT2031200383招募中2 期
ONO-4059(Bruton tyrosine kinase inhibitor) therapy for primary intraocular lymphoma :an investigator-initiated, randomised, double-blind,phase II clinical trial
Taoka Kazuki0 个研究点目标入组 38 人开始时间: 2021年3月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 38
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
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1.Patients diagnosed with primary intraocular lymphoma who are confirmed to be in complete remission by the central imaging committee with ocular lesions, brain and whole body imaging after local treatment of the affected eye(s)
- •2.Patients who can start administration of the investigational drug within 21 days of enrollment
- •3.Patients with a Performance Status (PS) of 0 or 1
- •4.Patients expected to survive for 3 months or longer at the time of official registration
- •5. For women of childbearing potential including patients who do not menstruate for medical reasons such as chemical menopause, patients who agree to use double contraception from the time of obtaining consent until at least 120 days after the last dose of investigational product
- •6. For men, patients who have consented to double contraception from the time of initiation of the study drug until at least 180 days after the last dose of the investigational product
- •7. Patients whose latest clinical laboratory tests performed during the screening period meet the following criteria
- •1) Neutrophil count of 1,000/mm3 or higher
- •2) Platelet count of more than 50,000 /mm3
- •3) Hemoglobin of 8.0 g/dL or higher
- •4) AST (GOT) and ALT (GPT) less than 2.5 times the upper limit of the institutional standard
- •5) Total bilirubin less than 1.5 times the upper limit of the institutional standard
- •6) Creatinine clearance of 30 mL/min (Cockcroft-Gault formula) or higher
排除标准
- •1. Patients with intraocular malignant lymphoma with brain lesions
- •2. Patients with systemic lymphoma lesions
- •3. Patients with secondary intraocular malignant lymphoma
- •4. Patients with T-cell lymphoma
- •5. Patients with unevaluable ocular lesions
- •6. Patients who received systemic chemotherapy or whole brain radiation therapy after the date of diagnosis of intraocular malignant lymphoma.
- •7.Patients who received radiation therapy or topical ocular therapy within 14 days prior to enrollment
- •8.Patients who underwent surgery within 28 days prior to official registration
- •9.Patients who received all unapproved medications within 28 days prior to enrollment, except for topical eye treatment
- •10. Patients who have been continuously using systemic corticosteroids (more than 10 mg/day of predonin equivalent) within 14 days prior to enrollment
- •11.Patients who received CYP3A4 inducer or P-gp inducer within 14 days prior to enrollment
- •12. Patients with a history of malignancy other than intraocular malignant lymphoma.
- •13. Patients with poorly controlled complications, severe cardiac disease or severe pulmonary disease that may affect protocol compliance or the determination of safety or efficacy.
- •14. Patients with active infections
- •15. Patients with a history of severe allergy or anaphylaxis in the past
- •16. Patients who are positive for any of the following tests: HIV-1 and HIV-2 antibody test, HTLV-1 antibody test, HBs antigen test, or HCV antibody test. In addition, patients whose HBs antigen test is negative but either HBs antibody test or HBc antibody test is positive and HBV-DNA quantification is above detection sensitivity.
- •17. Patients who cannot take tablets, patients with malabsorption, malabsorption syndrome, complications of diseases that significantly affect gastrointestinal function, patients who have had a complete resection of the stomach or small intestine, patients with ulcerative colitis, symptomatic inflammatory bowel disease, or patients with partial or complete intestinal obstruction
- •18.Patients who are pregnant, lactating, or may be pregnant
- •19.Patients who have received BTK inhibitors including ONO-4059 in the past.
- •20.Patients who are judged to lack the capacity to consent due to complications such as dementia.
- •21.Patients who are judged by the investigator or sub-investigator to be unsuitable for this study
研究者
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