2024-514824-18-00招募中2 期
Fixed-duration therapy with ibrutinib and obinutuzumab (GA-101) in treatment-naïve patients with CLL
Ospedale San Raffaele S.r.l.6 个研究点 分布在 1 个国家目标入组 53 人开始时间: 2024年8月5日最近更新:
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 53
- 试验地点
- 6
- 主要终点
- Percentage of patients with MRD <10-4 in BM at +30 follow-up days after completion of therapy
研究概览
简要总结
Evaluate the percentage of BM MRD <10-4 in BM at +30 days of follow-up after ibrutinib (Cycles 1-24) and obinutuzumab (Cycle 13 Days 1,2,8,15; Cycles 14-18 Day 1)
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Age >=18 years
- •Diagnosis of chronic lymphocytic leukemia (CLL) or small lymphocyte lymphoma (SLL) according to iwCLL diagnostic criteria
- •Previously untreated active disease requiring treatment according to iwCLL criteria
- •ECOG PS 0 or 1
- •Lymph node disease measurable (longest diameter> 1.5 cm) by CT
- •Adequate blood count defined as: Absolute neutrophil count (ANC)> 750 cells / μL (750 cells / mm3 or 0.75 x 109 / L), Platelet count> 30,000 / μL (30,000 cells / mm3 or 30 x 109 / L), Hemoglobin> 8.0 g / dL
- •Adequate liver and kidney function defined as: Serum aspartate transaminase (AST) or alanine transaminase (ALT) =3.0 x upper limit of normal (ULN) , Estimated Creatinine Clearance (CrCl) =30 mL / min (Cockcroft-Gault), Bilirubin =1.5 x ULN (unless increased bilirubin is due to Gilbert's syndrome or of non-hepatic origin)
- •Prothrombin time (PT) / International normal ratio (INR) <1.5 x ULN and PTT (activated partial thromboplastin time [aPTT]) <1.5 x ULN (unless abnormalities are related to coagulopathy or bleeding disorder)
排除标准
- •Any prior therapy (including but not limited to chemotherapy, targeted therapy, immunomodulatory therapy, radiotherapy, and / or monoclonal antibody) used to treat CLL or SLL.
- •Concomitant use of warfarin or other vitamin K antagonists.
- •Major surgery within 4 weeks of the first dose of study drug
- •Patients with del (17p) and / or TP53 mutation according to centralized laboratory assessment.
- •History of other malignancies, except: Malignant tumor treated with curative intent and with no known active disease present for =3 prior to first dose of study drug and deemed low risk of recurrence by treating physician, Malignant skin neoplasm not adequately treated or lentigo maligna with no evidence of disease, Adequately treated carcinoma in situ with no evidence of disease.
- •Known or suspected history of Richter's transformation.
- •Known hypersensitivity to one or more study drugs.
- •Known bleeding disorders (eg von Willebrand disease or haemophilia).
- •History of stroke or intracranial haemorrhage within 6 months prior to enrollment.
- •Known history of human immunodeficiency virus (HIV) or active hepatitis C virus (HCV) or hepatitis B virus (HBV) infection. Individuals who are positive for hepatitis B core antibody, hepatitis B surface antigen (HBsAg), or hepatitis C antibody must have a negative polymerase chain reaction (PCR) result before enrollment. Those who test positive for PCR will be excluded.
- •Inability to swallow capsules / tablets or malabsorption syndrome, any disease that significantly affects gastrointestinal function, or resection of the stomach or small intestine, symptomatic inflammatory bowel disease or ulcerative colitis, or partial or complete bowel obstruction.
结局指标
主要结局
Percentage of patients with MRD <10-4 in BM at +30 follow-up days after completion of therapy
Percentage of patients with MRD <10-4 in BM at +30 follow-up days after completion of therapy
次要结局
未报告次要终点
研究者
Paolo Ghia
Scientific
Ospedale San Raffaele S.r.l.
研究点 (6)
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