CTIS2024-510690-16-00进行中（未招募）1 期
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 - EZH-302
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Epizyme Inc.
- 入组人数
- 408
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •Have voluntarily agreed to provide written informed consent and demonstrated willingness and ability to comply with all aspects of the protocol., Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2., Have provided sufficient tumor tissue block or unstained slides for EZH2 mutation testing in all subjects to allow for stratification a. If EZH2 mutation status is known from site-specific testing, subjects can be enrolled. Tumor tissue will be required for confirmatory testing of EZH2 status at study-specific laboratories. If the archival tumor sample was collected more than 24 months prior to the anticipated administration of the first dose (cycle 1 day 1), then a fresh biopsy must be provided. Fresh tumor biopsy is appropriate except for procedures deemed to result in unacceptable risk because of the anatomical location including brain, lung/mediastinum, pancreas, or endoscopic procedures extending beyond the esophagus, stomach, or bowel. Archival tumor biopsy sections mounted on slides are also acceptable. NOTE: Confirmatory testing will also be performed for Stage 1, if local EZH2 testing is conducted, unless there is insufficient tumor tissue to perform testing after discussion with the Sponsor’s or Designee Medical Monitor., Time between prior anticancer therapy and first dose of tazemetostat as follows: a. Cytotoxic chemotherapy – At least 21 days. b. Noncytotoxic chemotherapy (eg, small molecule inhibitor) – At least 14 days. c. Nitrosoureas – At least 6 weeks. d. Monoclonal and/or bispecific antibodies or CAR T – At least 28 days. e. Radiotherapy – At least 6 weeks from prior radioisotope therapy; at least 12 weeks from 50% pelvic or total body irradiation., Adequate renal function defined as calculated creatinine clearance =30 mL/minute per the Cockcroft and Gault formula., Adequate bone marrow function: a. Absolute neutrophil count (ANC) =1000/mm3 (=1.0 × 10^9/L) if no lymphoma infiltration of bone marrow OR ANC =750/mm3 (=75 × 10^9/ L) with bone marrow infiltration • Without growth factor support (filgrastim or pegfilgrastim) for at least 14 days. b. Platelets =75,000/mm3 (=75 × 10^9/L) • Evaluated at least 7 days after last platelet transfusion. c. Hemoglobin =9.0 g/dL • May receive transfusion, Adequate liver function: a. Total bilirubin =1.5 × the upper limit of normal (ULN) except for unconjugated hyperbilirubinemia of Gilbert’s syndrome. b. Alkaline phosphatase (ALP) (in the absence of bone disease), alanine aminotransferase (ALT), and aspartate aminotransferase (AST) =3 × ULN (=5 × ULN if subject has liver infilration)., International normalized ratio (INR) =1.5 × ULN and activated partial thromboplastin time (aPTT) =1.5 × ULN (unless on warfarin, then INR =3.0). In subjects with thromboembolism risk, prophylactic anticoagulation, or antiplatelet therapy at investigator discretion is recommended., Females of childbearing potential (FCBP) must have a negative urine or serum pregnancy tests (beta-human chorionic gonadotropin [ß-hCG] tests with a minimum sensitivity of 25 mIU/mL or equivalent units of ß-hCG) at screening within 10 to 14 days prior to first dose of study drug. The subject may not receive study drug until the study doctor has verified that the results of pregnancy tests are negative. All females will be considered to be of childbearing potential unless they are naturally postmenopausal (at least 24 months consecutively amenorrhoeic [amenorrhea following cancer therapy does not rule out c
排除标准
- •Prior exposure to tazemetostat or other inhibitor(s) of EZH2., Major surgery within 4 weeks before the first dose of study drug. a. Note: Minor surgery (eg, minor biopsy of extracranial site, central venous catheter placement, shunt revision) is permitted within 3 weeks prior to enrollment., 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., Prolongation of corrected QT interval using Fridericia’s formula (QTcF) to =480 msec at screening or history of long QT syndrome., Venous thrombosis or pulmonary embolism within the last 3 months before starting tazemetostat. a. Note: Participants who have experienced deep vein thrombosis/ pulmonary embolism more than 3 months before enrollment are eligible but are recommended to receive prophylaxis, Have an active infection requiring systemic therapy., Known hypersensitivity to any component of tazemetostat or lenalidomide; known severe hypersensitivity to any component of rituximab requiring hospitalization or resuscitation., Active viral infection with or seropositive for HBV: HBV surface antigen (HBsAg) positive OR HBsAg negative, anti-HBs positive and/or anti-HBc positive with detectable HBV DNA. NOTE: Subjects who are HBsAg negative, anti-HBs positive and/or anti-HBc positive, but with undetectable viral DNA and normal ALT are eligible. Subjects who are seropositive due to HBV vaccination (HBsAg negative, HBV surface antibody [anti-HBs] positive, and HBV core antibody [anti-HBc] negative) are eligible., Active viral infection with hepatitis C virus (as measured by positive HCV antibody and detectable viral RNA, HIV), or known active infection with human T-cell lymphotropic virus. NOTE: Subjects with a history of hepatitis C infection (HCV antibody reactive) who have normal ALT and undetectable HCV RNA are eligible., Any other medical or social condition that, in the Investigator’s judgment, will interfere with a participant’s ability to provide informed consent, to receive study drugs, or meet study demands, or that substantially increases the risk associated with the subject’s participation in the study, or that may interfere with interpretation of results., Female subjects who are pregnant or lactating/breastfeeding., 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., Subjects who have undergone a solid organ transplant., Subjects with malignancies other than FL. a. Exception: Subjects with another malignancy who have been disease-free for 3 years, or subjects with a history of a completely resected non-melanoma skin cancer or successfully treated in situ carcinoma are eligible., Prior exposure to lenalidomide or drugs of the same class., Grade 3b, mixed histology, or FL that has histologically transformed to diffuse large B-cell lymphoma (DLBCL) (subjects transformed from DLBCL to FL may be enrolled)., 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)., Has a prior history of T-cell lymphoblastic lym
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