An Open Label Phase 2 Study of Denintuzumab Mafodotin (SGN-CD19A) in Combination With RCHOP (Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone) or RCHP (Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone) Compared With RCHOP Alone as Frontline Therapy in Patients With Diffuse Large B-cell Lymphoma (DLBCL) or Follicular Lymphoma (FL) Grade 3b

Seagen Inc.35 个研究点分布在 2 个国家目标入组 24 人开始时间: 2016年8月最近更新: 2019年3月11日

适应症

干预措施

试验速览

阶段: 2 期
状态: 终止
发起方: Seagen Inc.
入组人数: 24
试验地点: 35
主要终点: Part B Outcome Measure: Complete Response Rate (CR)

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

This is a Phase 2 study to evaluate the combination of denintuzumab mafodotin in combination with RCHOP or RCHP compared with RCHOP alone as front-line therapy in patients with diffuse large B-cell lymphoma or follicular lymphoma Grade 3b.

详细描述

In Part A of the study, patients will be randomized 1:1 to receive denintuzumab mafodotin plus RCHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) or denintuzumab mafodotin plus RCHP (rituximab, cyclophosphamide, doxorubicin, and prednisone) to assess the safety of these 2 combination regimens. Part B of the study is designed to evaluate the antitumor activity and safety of denintuzumab mafodotin in combination with either RCHOP or RCHP (Experimental Arm) compared with RCHOP alone (Comparator Arm).

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Treatment
盲法: None

入排标准

年龄范围: 18 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Treatment-naive patients with histologically confirmed systemic de novo or transformed diffuse large B-cell lymphoma (DLBCL) (from follicular or marginal zone lymphoma), or follicular lymphoma (FL) Grade 3b;
•patients must have high intermediate or high risk disease
•Tumor tissue available from most recent biopsy to determine cell of origin
•Fluorodeoxyglucose-avid disease by positron emission tomography and measurable disease greater than 1.5cm diameter
•Eastern Cooperative Oncology Group performance status ≤2
•Age 18 years or older
•Adequate study baseline laboratory parameters

排除标准

•Previous history of treated indolent lymphoma
•History of another primary invasive cancer, hematologic malignancy, or myelodysplastic syndrome that has not been in remission for at least 3 years
•History of progressive multifocal leukoencephalopathy
•Cerebral/meningeal disease related to the underlying malignancy
•Patients with the following ocular conditions: corneal disorders, monocular vision (ie. best corrected visual acuity greater than or equal to 20/200 in one eye), or active ocular disorders requiring treatment

研究组 & 干预措施

denintuzumab mafodotin + RCHOP or RCHP

Experimental

Part B: denintuzumab mafodotin (SGN-CD19A) + RCHOP or RCHP

干预措施: rituximab (Drug)