EUCTR2019-003333-42-BE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 - SYMPHONY-1
Epizyme, Inc; an Ipsen Company0 个研究点目标入组 568 人开始时间: 2020年9月29日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 568
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
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.
- •b. Systemic therapy does not include, for example: i. Local involved field radiotherapy for limited-stage disease ii. Helicobacter pylori eradication
- •c. Prior investigational therapies will be allowed provided the patient has received at least 1 prior systemic therapy as discussed in Inclusion Criterion #6a.
- •d. Prior autologous/allogeneic hematopoietic stem cell transplant (HSCT) will be allowed.
- •e. Prior chimeric antigen receptor T-cell therapy (CAR T) will be allowed.
- •7. Must have documented relapsed, refractory, or PD after treatment with systemic therapy (refractory defined as less than PR or disease progression <6 months after last dose).
- •8. Within 7 days prior to randomization, all clinically significant toxicity related to a prior anticancer treatment (i.e. chemotherapy, immunotherapy, and/or radiotherapy) must have either resolved to Grade 1 per National Cancer Institute CTCAE Version 5.0 OR are clinically stable and no longer clinically significant.
- •9. 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.
- •10. Adequate renal function defined as calculated creatinine clearance = 30 mL/minute per the Cockcroft and Gault formula.
- •11. Adequate bone marrow function
- •12. Adequate liver function
- •13. Females of childbearing potential (FCBP) enrolled must either practice complete abstinence or agree to use two reliable methods of contraception simultaneously. This includes ONE highly effective method of contraception and ONE additional effective contraceptive method.
- •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 261
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 307
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.
- •10. Prolongation of corrected QT interval using Fridericia's formula (QTcF) to =480 msec at screening or history of long QT syndrome.
- •11. Venous thrombosis or pulmonary embolism within the last 3 months before starting tazemetostat.
- •Note: Patients who have experienced deep vein thrombosis/pulmonary embolism more
- •than 3 months before enrollment are eligible but are recommended to receive prophylaxis.
- •12. Have an active infection requiring systemic therapy.
- •13. Known hypersensitivity to any component of tazemetostat or lenalidomide; known severe hypersensitivity to any component of rituximab requiring hospitalization or resuscitation.
- •14. (No longer applicable with PA4: Inability to be treated with a Pneumocystis prophylaxis medication.
- •15. 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: Patients who are HBsAg negative, anti-HBs positive and/or anti- HBc positive, but with undetectable viral DNA and normal ALT are eligible. Patients who are seropositive due to HBV vaccination (HBsAg negative, HBV surface antibody [anti-HBs] positive, and HBV core antibody [anti-HBc] negative) are eligible.
- •16. Active viral infection with hepatitis C virus (as measured by positive HCV antibody and detectable viral RNA), human immunodeficiency virus (HIV), AND/OR human T-cell lymphotropic virus 1 (as measured by positive HTLV-1 antibody) or known history of HIV positive status.
- •NOTE: Patients with a history of hepatitis C infection (HCV antibody reactive) who have normal ALT and undetectable HCV RNA are eligible.
- •17. Any other medical or social condition that, in the Investigator’s judgment, will interfere with a patient’s ability to provide informed consent, to receive study drugs, or meet study demands,
- •or that substantially increases the risk associated with the patient’s participation in the study, or
- •that may interfere with interpretation of results.
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