CTIS2023-509793-38-00招募中1 期
Ibrutinib for the Treatment of Autoimmune Hemolytic Anemia in Patients with Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma or CLL-like monoclonal B-cell lymphocytosis. CLL2323 - CLL2323
Fondazione Gimema Franco Mandelli Onlus0 个研究点目标入组 45 人开始时间: 2024年7月2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
- 45
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
- •Diagnosis of CLL/small lymphocytic lymphoma (SLL) or CLL-like monoclonal B-cell lymphocytosis (MBL) according to IWCLL guidelines, Willingness of men and WOCBP, and their partners, to observe the contraceptive measures until the end of systemic exposure, Willingness of men not to father a child or donate sperm while receiving ibrutinib, and for 3 months following completion of treatment, Patients >18 years old, Active AIHA (warm AIHA, wAIHA, or cold hemagglutinin disease, CAD) that i) is relapsed after previous treatment with corticosteroids (with or without rituximab), or ii) is steroid-resistant (failure to obtain hematologic response within 3 weeks on at least 1 mg/kg predniso(lo)ne (2)), or iii) is steroid-dependent (need to continue on predniso (lo)ne at a dose of >10 mg/day to maintain a response (2)). AIHA is defined as: anemia (hemoglobin =10 g/dL; or hemoglobin >10 g/dL dependent on transfusions to maintain this level of hemoglobin) and laboratory evidence of hemolysis (presence of 3 of 4 markers: increased reticulocyte count, increased indirect bilirubin, increased lactate dehydrogenase, decreased haptoglobin) and positive DAT (either IgG DAT, C3 DAT or both)., Eligibility of patients with DAT-negative active AIHA should be confirmed by the Principal Investigator and co-Principal Investigator for the trial, Signed written informed consent according to ICH/EU/GCP and national local laws, Eastern Cooperative Oncology Group (ECOG) =2, Adequate renal and hepatic function, per laboratory reference range at screening as follows: o Aspartate aminotransferase (AST) =< 3.0 x ULN (within 30 days prior to day 1 of protocol therapy) o Alanine aminotransferase (ALT) =< 3.0 x ULN (within 30 days prior to day 1 of protocol therapy) o Creatinine clearance of >= 30 mL/min per 24-hour urine test or the Cockcroft-Gault formula (within 30 days prior to day 1 of protocol therapy), Ability to swallow oral study medication, Women of childbearing potential (WOCBP): negative urine or serum pregnancy test within the screening window prior to receiving the first dose of study medication and monthly pregnancy test until the end of systemic exposure
排除标准
- •Contraindication to ibrutinib therapy as per treating physician’s discretion., Contraindication to ibrutinib therapy as per ibrutinib data sheet (severe hepatic impairment, known allergy to the drug or to one of the excipients, concomitant treatment with warfarin or other vitamin K antagonists), Active infection with hepatitis B virus (HBV) or hepatitis C virus (HCV) or known positive human immunodeficiency virus (HIV) o Participants who are hepatitis B core antibody (anti-HBc) positive and who are surface antigen negative will need to have a negative polymerase chain reaction (PCR). Those who are hepatitis B surface antigen (HbsAg) positive or hepatitis B PCR positive will be excluded. o Subjects who are hepatitis C antibody positive will need to have a negative PCR result. Those who are hepatitis C PCR positive will be excluded o Subjects who have an undetectable or unquantifiable HIV viral load with CD4 > 300 and are on highly active antiretroviral therapy (HAART) medication are allowed. Testing to be done only in patients suspected of having infections or exposures - Previous exposure to ibrutinib as CLL-directed therapy, Previous exposure to ibrutinib as CLL-directed therapy, Treatment with another investigational drug or device, or approved therapy for investigational use – with the exception of corticosteroids - 28 days prior to Cycle 1 Day 1, or if the half-life of the previous investigational product is known, within 5 times the half-life prior to Cycle 1 Day 1, whichever is longer, Clinically significant active malabsorption syndrome or other condition likely to affect gastrointestinal absorption of the oral-administered study treatments, Vaccination with a live vaccine within 28 days prior to Cycle 1 Day 1, Female patients who are currently in pregnancy or are willing to be pregnant or are lactating.
研究者
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