Phase Ib - II Study of Entospletinib (ENTO) in Newly Diagnosed Diffuse Large B Cell Lymphoma (DLBCL) Patients With aaIPI>=1 Treated by Rituximab, Cyclophosphamide, Hydroxydaunomycin, Oncovin, and Prednisone (R-CHOP)

The Lymphoma Academic Research Organisation27 个研究点分布在 2 个国家目标入组 25 人开始时间: 2017年7月26日最近更新: 2020年9月2日

适应症

干预措施

试验速览

阶段: 1 期
状态: 终止
发起方
入组人数: 25
试验地点: 27
主要终点: Phase II: Complete Metabolic Response (CMR) rate at the end of treatment

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The primary objective of the phase Ib of the study is to determine the recommended phase 2 dose (RP2D) for entospletinib (ENTO) in patients treated with R-CHOP.

The primary objective of the phase II is to determine the complete metabolic response (CMR) rate by the Lugano classification 2014 (Deauville scale 1-3) at the end of treatment.

研究设计

研究类型: Interventional
分配方式: Na
干预模型: Single Group
主要目的: Treatment
盲法: None

入排标准

年龄范围: 60 Years 至 80 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Patients with histologically confirmed de novo DLBCL (CD20 positive) (cf section 20.6 - Appendix 4)
•Age between 60 and 80 years included, on the day of the informed consent document signature
•Age adjusted International Prognosis Index (aaIPI) score ≥ 1
•No prior treatment for DLBCL. However prephase treatment with 1mg/kg/day prednisone or equivalent, for a maximum of 14 days, is permitted prior to begin the treatment
•Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2 (0 or 1 only for phase 1b)
•Life expectancy of ≥ 90 days (3 months) before starting Entospletinib
•Signed informed consent
•At least one bi-dimensionally measurable lesion defined as at least one node or tumor lesion on CT scan ≥ 1.5 cm
•fluorodeoxyglucose (FDG) positron emission tomography (PET-CT) performed at baseline with a FDG positive result
•Adequate hematologic functions defined as follows (unless secondary to bone marrow involvement by lymphoma):
•Absolute neutrophil count (ANC) > 1.5 X 10^9 G/l and
•Platelets count ≥ 75 X 10^9/l without platelet transfusion dependency during the last 7 days and
•Haemoglobin level > 9 g/dl (may receive transfusion)
•Adequate liver function defined as follows:
•Total bilirubin <1.5 upper limit of normal (ULN) except for unconjugated hyperbilirubinemia of Gilbert's syndrome and
•Alkaline phosphatase (in absence of bone disease), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 3 X ULN
•Adequate renal function as calculated by a creatinine clearance > 40 ml/min by local institutional formula
•Patients with prior Hepatitis B must be given antiviral prophylaxis and hepatitis B virus (HBV) DNA monitored; Patients with prior Hepatitis C are eligible if, hepatitis C virus (HCV) RNA is undetectable.
•Left ventricular ejection fraction (LVEF) ≥ 50% of echocardiography or multiple gated acquisition (MUGA) scan
•Adequate tissue for central retrospective testing for cell of origin (10-15 slides of tumor biopsy must be available at baseline)
•Heterosexually active females of childbearing potential (as defined in the protocol) must:
•have a negative serum pregnancy test at baseline and prior to the first study drug administration (C1D-4)
•have practiced at least 1 reliable method of contraception for at least 2 months prior to the first study drug administration (C1D-4)
•agree to utilize highly effective methods of contraception (as defined in the protocol) from Cycle 1 Day -4 until 12 months following the last treatment administration
•Heterosexually active males with partners of childbearing potential must agree to use reliable forms of contraception during treatment and up to 12 months after last treatment administration
•Male subjects must agree to avoid sperm donation from Cycle 1 Day -4 until 12 months following the last treatment administration