A Phase II Study of PNT2258 in Patients With Richter's Transformation (RT) - Brighton

ProNAi Therapeutics, Inc.0 个研究点目标入组 49 人开始时间: 2015年10月29日最近更新: 2016年8月8日

研究概览

暂无简介。

•1) Written informed consent
•2) =18 years of age
•3) Histologically confirmed diagnosis of diffuse large B-cell lymphoma in the setting of Richter's Transformation (RT) from chronic lymphocytic leukemia /small lymphocytic lymphoma (CLL/SLL)
•4) Availability of fresh or archived tumor tissue
•5) FDG PET-CT disease-positive baseline scan
•6) ECOG performance status of 0-1
•7) Evidence of disease progression at study entry
•8) Discontinuation of prior anticancer therapy for =7 days and recovery to = CTCAE grade 2 (or baseline) from any acute or chronic toxicity associated with prior therapy
•9) Previously received at least one prior regimen for CLL
•10) Adequate organ function
•11) Adequate bone marrow function
•12) Normal coagulation profile
•13) Ability to participate in the clinical study for at least 2 cycles (6 weeks)
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 10
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 39

•1) Concurrent non-hematologic malignancies requiring treatment
•2) More than 1 prior regimen for DLBCL
•3) Hodgkin's variant of Richter's lymphoma, accelerated CLL, composite lymphoma (i.e., discovery of CLL and another lymphoma at time of original diagnosis), interdigitating dendritic cell sarcoma, sarcoma, EBV-associated lymphoma or prolymphocytic transformation
•4) Ongoing risk of bleeding due to active peptic ulcer disease or known bleeding diathesis or requirement for systemic therapeutic levels of anticoagulation with unfractionated heparin, low-molecular-weight heparin or heparin fractions or oral anticoagulants
•5) Central nervous system (CNS) or leptomeningeal involvement of lymphoma
•6) Concurrent clinically significant illness or medical condition that could adversely affect subject safety or the integrity of study results, as determined by the Investigator

发起方

ProNAi Therapeutics, Inc.