SYMPHONY-1: A Phase 1b/3 double-blind, randomized, active-controlled, 3-stage, biomarker adaptive study of tazemetostat or placebo in combination with lenalidomide plus rituximab in subjects with relapsed/refractory follicular lymphoma - SYMPHONY-1

Epizyme, Inc; an Ipsen Company0 个研究点目标入组 568 人2020年9月29日

适应症Relapsed/refractory follicular lymphoma MedDRA version: 24.0Level: HLTClassification code 10016903Term: Follicle centre lymphomas, follicular grade I, II, IIISystem Organ Class: 10016903 - Follicle centre lymphomas, follicular grade I, II, III Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

概览

阶段: 1 期
干预措施: 未指定
疾病 / 适应症: Relapsed/refractory follicular lymphoma
发起方: Epizyme, Inc; an Ipsen Company
入组人数: 568
状态: 进行中（未招募）
最后更新: 去年

概览研究者入排标准结局指标相似试验

概览

简要总结

暂无简介。

注册库

who.int

开始日期

2020年9月29日

结束日期

待定

最后更新

去年

研究类型

Interventional clinical trial of medicinal product

性别

All

研究者

发起方

Epizyme, Inc; an Ipsen Company

入排标准

入选标准

•1\. Have voluntarily agreed to provide written informed consent and demonstrated willingness and ability to comply with all aspects of the protocol.
•2\. Males or females are \=18 years of age (\=20 years for Taiwan) at the time of providing voluntary written informed consent.
•3\. Life expectancy \=3 months before enrollment.
•4\. Meet requirements for hepatitis and human immunodeficiency virus (HIV) infection as
•Negative serologic or polymerase chain reaction (PCR) test results for acute or chronic hepatitis B virus (HBV) infection.
•Negative test results for hepatitis C virus (HCV) and human immunodeficiency virus.
•If HIV positive, HIV infection is controlled.
•5\. Have histologically confirmed FL, Grades 1 to 3A.
•6\. Must have been previously treated with at least 1 prior systemic chemotherapy, immunotherapy, or chemoimmunotherapy:
•a. Systemic therapy includes treatments such as: i. Rituximab monotherapy ii. Chemotherapy given with or without rituximab iii. Radioimmunoconjugates such as 90Y\-ibritumomab tiuxetan and 131I\-tositumomab.

排除标准

•1\. Prior exposure to tazemetostat or other inhibitor(s) of EZH2\.
•2\. Prior exposure to lenalidomide.
•3\. Grade 3b, mixed histology, or FL that has histologically transformed to diffuse large B\-cell lymphoma (DLBCL) (patients transformed from DLBCL to FL may be enrolled).
•4\. Has thrombocytopenia, neutropenia, or anemia of Grade \=3 (per CTCAE Version 5\.0 criteria) or any prior history of myeloid malignancies, including myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) or myeloproliferative neoplasm (MPN).
•5\. Has a prior history of T\-cell lymphoblastic lymphoma (T\-LBL)/T\-cell acute lymphoblastic leukemia (T\-ALL).
•6\. Patients with uncontrolled leptomeningeal metastases or brain metastases or history of previously treated brain metastases.
•7\. Major surgery within 4 weeks before the first dose of study drug.
•Note: Minor surgery (eg, minor biopsy of extracranial site, central venous catheter placement, shunt revision) is permitted within 3 weeks prior to enrollment.
•8\. Are unable to take oral medication or have malabsorption syndrome or any other uncontrolled gastrointestinal condition (eg, nausea, diarrhea, vomiting) that might impair the bioavailability of tazemetostat.
•9\. Significant cardiovascular impairment: history of congestive heart failure greater than New York Heart Association (NYHA) Class II, uncontrolled arterial hypertension, unstable angina, myocardial infarction, or stroke within 6 months of the first dose of study drug; or cardiac ventricular arrhythmia.