Ignite Creation Date:
2025-12-25 @ 1:10 AM
Ignite Modification Date:
2025-12-25 @ 11:21 PM
Study NCT ID:
NCT04224493
Status:
RECRUITING
Last Update Posted:
2025-12-16
First Post:
2019-12-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Assess the Efficacy, Safety, Pharmacodynamics, and Pharmacokinetics of Tazemetostat in Combination With Lenalidomide Plus Rituximab Versus Placebo in Combination With Lenalidomide Plus Rituximab in Adult Patients at Least 18 Years of Age With Relapsed/Refractory Follicular Lymphoma.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008224', 'term': 'Lymphoma, Follicular'}], 'ancestors': [{'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000593333', 'term': 'tazemetostat'}, {'id': 'D000077269', 'term': 'Lenalidomide'}, {'id': 'D000069283', 'term': 'Rituximab'}], 'ancestors': [{'id': 'D010797', 'term': 'Phthalimides'}, {'id': 'D010795', 'term': 'Phthalic Acids'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010881', 'term': 'Piperidones'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D054833', 'term': 'Isoindoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D058846', 'term': 'Antibodies, Monoclonal, Murine-Derived'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': '3 stages study:\n\nStage 1:\n\nOpen-Label (Phase 1b: Safety run-in): All participants will receive Tazemetostat in combination with Lenalidomide and Rituximab\n\nStage 2:\n\nDouble-blinded (Phase 3):\n\n* Study drug arm: Tazemetostat in combination with Lenalidomide and Rituximab\n* Placebo arm: Placebo in combination with Lenalidomide and Rituximab\n\nStage 3:\n\nLong-term Follow-up of participants in Stage 2 after treatment for response, when applicable, and overall survival for up to 5 years after the enrollment of the last patient in the study.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 612}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-06-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2029-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-10', 'studyFirstSubmitDate': '2019-12-12', 'studyFirstSubmitQcDate': '2020-01-08', 'lastUpdatePostDateStruct': {'date': '2025-12-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2020-01-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recommended Phase 3 Dose (RP3D) of tazemetostat in combination with rituximab and lenalidomide (R2)', 'timeFrame': 'Subjects are evaluated for DLTs during the first 28-day cycle. The RP3D for Phase 3 was selected at the end of Stage 1', 'description': 'The safety and tolerability of tazemetostat in combination with R2 in subjects with R/R FL will be evaluated. RP3D of tazemetostat for further evaluation in phase 3 will be selected as assessed by the occurrence of treatment-emergent dose-limiting toxicities (DLTs) and adverse events (AEs).'}, {'measure': 'Progression-Free Survival (PFS) in the Intent-to-treat wild-type (ITT-WT) population', 'timeFrame': 'Stage 2: Up to 72 months', 'description': 'PFS is defined as the time from the date of randomization to the time of confirmed disease progression per the 2014 Lugano Classification or death, whichever occurs first, as assessed by Investigators.'}, {'measure': 'PFS in the Intent-to-treat mutant-type (ITT-MT) population', 'timeFrame': 'Stage 2: Up to 72 months', 'description': 'PFS is defined as the time from the date of randomization to the time of confirmed disease progression per the 2014 Lugano Classification or death, whichever occurs first, as assessed by Investigators.'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetics (PK) of tazemetostat: Maximum (peak) Observed Plasma Drug Concentration (Cmax).', 'timeFrame': 'Stage 1: In cycles 1 and 2 on days 1 and 15 (28 days cycle)', 'description': 'Cmax will be recorded from the PK blood samples collected.'}, {'measure': 'PK of tazemetostat, EPZ 6930 (desethyl metabolite), and lenalidomide as data permit: Time to Maximum Observed Drug Concentration (Tmax)', 'timeFrame': 'Stage 1: In cycles 1 and 2 on days 1 and 15 (28 days cycle)'}, {'measure': 'PK of tazemetostat: area under the plasma concentration-time curve (AUC) from time 0 to the time of the last quantifiable concentration [AUC(0-t)],', 'timeFrame': 'Stage 1: In cycles 1 and 2 on days 1 and 15 (28 days cycle)'}, {'measure': 'PK of tazemetostat: area under the plasma concentration-time curve (AUC) from time 0 to infinity [AUC(0-∞)]', 'timeFrame': 'Stage 1: In cycles 1 and 2 on days 1 and 15 (28 days cycle)'}, {'measure': 'The apparent terminal elimination half-life (t1/2) of tazemetostat, EPZ 6930 (desethyl metabolite), and lenalidomide as data permit', 'timeFrame': 'Stage 1: In cycles 1 and 2 on days 1 and 15 (28 days cycle)'}, {'measure': 'Complete Response Rate (CRR) in ITT-WT population', 'timeFrame': 'Stage 2: Up to 96 months', 'description': 'CRR is defined as the proportion of participants achieving CR according to the 2014 Lugano Classification, as assessed by the Investigator and a blinded Independent Review Committee (IRC).'}, {'measure': 'CRR in ITT-MT population', 'timeFrame': 'Stage 2: Up to 96 months', 'description': 'CRR is defined as the proportion of participants achieving CR according to the 2014 Lugano Classification, as assessed by the Investigator and a blinded IRC.'}, {'measure': 'CRR in the Relapsed/Refractory (R/R) Follicular Lymphoma (FL) population regardless of mutation status', 'timeFrame': 'Stage 2: Up to 96 months', 'description': 'CRR is defined as the proportion of participants achieving CR according to the 2014 Lugano Classification, as assessed by the Investigator and a blinded IRC.'}, {'measure': 'Objective Response Rate (ORR) in the ITT-WT population', 'timeFrame': 'Stage 2: Up to 96 months', 'description': 'ORR is defined as the proportion of participants achieving a best overall response (BOR) of partial response (PR) or complete response (CR) according to the 2014 Lugano Classification, as assessed by the Investigator and a blinded IRC.'}, {'measure': 'ORR in the ITT-MT population', 'timeFrame': 'Stage 2: Up to 96 months', 'description': 'ORR is defined as the proportion of participants achieving a best overall response (BOR) of partial response (PR) or complete response (CR) according to the 2014 Lugano Classification, as assessed by the Investigator and a blinded IRC.'}, {'measure': 'ORR in the R/R FL population regardless of mutation status', 'timeFrame': 'Stage 2: Up to 96 months', 'description': 'ORR is defined as the proportion of participants achieving a best overall response (BOR) of partial response (PR) or complete response (CR) according to the 2014 Lugano Classification, as assessed by the Investigator and a blinded IRC.'}, {'measure': 'Overall Survival (OS) in the ITT-WT population', 'timeFrame': 'Stage 2: Up to 96 months', 'description': 'OS is defined as the time from the date of randomization until death due to any cause.'}, {'measure': 'OS in the ITT-MT population', 'timeFrame': 'Stage 2: Up to 96 months'}, {'measure': 'OS in the R/R FL population regardless of mutation status', 'timeFrame': 'Stage 2: Up to 96 months'}, {'measure': 'PFS in the ITT-WT population, assessed by a blinded IRC', 'timeFrame': 'Stage 2: Up to 96 months'}, {'measure': 'PFS in the ITT-MT population, assessed by a blinded IRC', 'timeFrame': 'Stage 2: Up to 96 months'}, {'measure': 'PFS in the R/R FL population regardless of mutation status, assessed by a blinded IRC', 'timeFrame': 'Stage 2: Up to 96 months'}, {'measure': 'PFS in the R/R FL population regardless of mutation status, assessed by the Investigator', 'timeFrame': 'Stage 2: Up to 96 months'}, {'measure': 'Duration Of Response (DOR) in the ITT-WT population', 'timeFrame': 'Stage 2: Up to 96 months', 'description': 'DOR is defined as the time from initial CR or PR to documented progression or death due to any cause, whichever occurs first, for those participants with a CR or PR, as assessed by the Investigator and by a blinded IRC.'}, {'measure': 'DOR in the ITT-MT population', 'timeFrame': 'Stage 2: Up to 96 months', 'description': 'DOR is defined as the time from initial CR or PR to documented progression or death due to any cause, whichever occurs first, for those participants with a CR or PR, as assessed by the Investigator and by a blinded IRC.'}, {'measure': 'DOR in the R/R FL population regardless of mutation status', 'timeFrame': 'Stage 2: Up to 96 months', 'description': 'DOR is defined as the time from initial CR or PR to documented progression or death due to any cause, whichever occurs first, for those participants with a CR or PR, as assessed by the Investigator and by a blinded IRC.'}, {'measure': 'Duration Of Complete Response (DOCR) in the ITT-WT population', 'timeFrame': 'Stage 2: Up to 96 months', 'description': 'DOCR is defined as the time from initial CR to documented progression or death due to any cause, whichever occurs first, for those participants with CR, assessed by the Investigator and by a blinded IRC.'}, {'measure': 'DOCR in the ITT-MT population', 'timeFrame': 'Stage 2: Up to 96 months', 'description': 'DOCR is defined as the time from initial CR to documented progression or death due to any cause, whichever occurs first, for those participants with CR, assessed by the Investigator and by a blinded IRC.'}, {'measure': 'DOCR in the R/R FL population regardless of mutation status', 'timeFrame': 'Stage 2: Up to 96 months', 'description': 'DOCR is defined as the time from initial CR to documented progression or death due to any cause, whichever occurs first, for those participants with CR, assessed by the Investigator and by a blinded IRC.'}, {'measure': 'Disease Control Rate (DCR) in the ITT-WT population', 'timeFrame': 'Stage 2: Up to 96 months', 'description': 'DCR, defined as the proportion of participants with best overall response of CR, PR, or stable disease (SD) lasting 12 or more months, as assessed by the Investigator and by a blinded IRC.'}, {'measure': 'DCR in the ITT-MT population', 'timeFrame': 'Stage 2: Up to 96 months', 'description': 'DCR, defined as the proportion of participants with best overall response of CR, PR, or stable disease (SD) lasting 12 or more months, as assessed by the Investigator and by a blinded IRC.'}, {'measure': 'DCR in the R/R FL population regardless of mutation status', 'timeFrame': 'Stage 2: Up to 96 months', 'description': 'DCR, defined as the proportion of participants with best overall response of CR, PR, or stable disease (SD) lasting 12 or more months, as assessed by the Investigator and by a blinded IRC.'}, {'measure': 'Population PK parameters of oral clearance (CL/F) of tazemetostat', 'timeFrame': 'Stage 2: In cycles 2, 4, 6, and 12 at Day 1 (28 days cycle)', 'description': 'CL/F will be used to generate estimates of tazemetostat AUC'}, {'measure': 'Population PK parameters of oral volume of distribution (Vd/F) of tazemetostat.', 'timeFrame': 'Stage 2: In cycles 2, 4, 6, and 12 at Day 1 (28 days cycle)'}, {'measure': 'Population PK parameters of first-order absorption rate constant (Ka) for tazemetostat.', 'timeFrame': 'Stage 2: In cycles 2, 4, 6, and 12 at Day 1 (28 days cycle)'}, {'measure': 'Percentage of Participants Experiencing Adverse Events (AEs)', 'timeFrame': 'Up to 36 months', 'description': 'An Adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.'}, {'measure': 'Percentage of Participants with Clinically Significant Changes in Physical Examination', 'timeFrame': 'Up to 36 months', 'description': 'Percentage of participants with clinically significant changes in physical examination findings will be reported. The clinical significance will be graded by the investigator according to the National Cancer Institute Common Terminology Criteria for AEs (CTCAE) Version 5.0.'}, {'measure': 'Percentage of Participants with Clinically Significant Changes in Vital Signs', 'timeFrame': 'Up to 36 months', 'description': 'Percentage of participants with clinically significant changes in vital signs findings will be reported. The clinical significance will be graded by the investigator according to the National Cancer Institute Common Terminology Criteria for AEs (CTCAE) Version 5.0.'}, {'measure': 'Percentage of Participants with Clinically Significant Changes in Electrocardiogram (ECG) Readings', 'timeFrame': 'Up to 72 months', 'description': 'Percentage of participants with clinically significant changes in ECG Readings will be reported. The clinical significance will be graded by the investigator according to the National Cancer Institute Common Terminology Criteria for AEs (CTCAE) Version 5.0.'}, {'measure': 'Performance status evaluated by Eastern Cooperation Oncology Group (ECOG)', 'timeFrame': 'Up to 72 months', 'description': 'ECOG is a 6-point performance status scale used to assess performance using PA as a key indicator (e.g., 0 = fully active, 2 = up and about more than 50% of walking hours, 5 = dead) Performance status will be assessed per usual clinical practice and will be recorded in the medical record.'}, {'measure': 'Duration of Study Drug Exposure', 'timeFrame': 'Up to 36 months', 'description': 'Duration of exposure to study drug will be reported.'}, {'measure': 'Percentage of study drug taken by participants', 'timeFrame': 'Up to 36 months'}, {'measure': 'Quality of life questionnaires evaluation', 'timeFrame': 'Up to 36 months', 'description': 'Evaluate and compare health-related quality of life as measured by the EuroQOL 5-Dimension 5-Level (EQ-5D-5L) instrument and the Functional Assessment of Cancer Therapy -Lymphoma (FACT-Lym)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Epizyme', 'Tazverik', 'Tazemetostat (EPZ-6438)', 'Lenalidomide', 'Revlimid', 'Rituximab', 'Rituxan', 'Follicular lymphoma', 'EZH2'], 'conditions': ['Relapsed/Refractory Follicular Lymphoma', 'Follicular Lymphoma', 'Refractory Follicular Lymphoma']}, 'referencesModule': {'references': [{'pmid': '40896460', 'type': 'DERIVED', 'citation': 'Cao J, Chen G, Qiu L, Zhang L, Jiang M, Cheng Y, Zhang Q, Liu L, Li P, Shuang Y, Wang H, Xue H, Wu H, Zheng M, Zhou K, Li Z, Jing H, Yang W, Zhu Z, Li W, Wangwu J, Huang H, Jia Q, Chen D, Fan S, Shi MM, Su W. Efficacy and safety of tazemetostat, an EZH2 inhibitor, in Chinese patients with relapsed/refractory follicular lymphoma: a multicentre, single-arm, phase 2 study. EClinicalMedicine. 2025 Aug 18;87:103399. doi: 10.1016/j.eclinm.2025.103399. eCollection 2025 Sep.'}]}, 'descriptionModule': {'briefSummary': "The participants of this study would have relapsed/refractory follicular lymphoma.\n\nFollicular lymphoma is a type of blood cancer. It is referred to as 'relapsed' when the disease has come back after a period of improvement after that follows a treatment regimen and 'refractory' when treatment no longer works.\n\nStage 1 of this trial will study the safety and the level that adverse effects of each of the study drug combinations can be tolerated (known as tolerability). It is also designed to establish a recommended study drug dosage for stage 2 and 3. Stage 1 of the study is completed.\n\nStages 2 and 3 will evaluate and compare how long participants live without their disease getting worse when receiving the study drug in combination with other drug treatment versus the placebo (dummy drug) in combination with other drug treatment.", 'detailedDescription': 'Stage 1 of the study, which is now completed, looked at the safety and tolerability of the drug combinations and helped determine the recommended dose for the next stages.\n\nIn Stage 2, participants will be grouped based on whether they have a specific genetic mutation called EZH2. All participants will receive treatment in 28-day cycles. After 12 cycles, they will continue with maintenance treatment using either the study drug or a placebo, depending on their original group.\n\nThe study will include participants with and without the EZH2 mutation. Enrollment may be completed separately for each group. In China, some participants will also have extra blood tests to better understand how the drug behaves in the body.\n\nStage 3 will focus on long-term follow-up to monitor how well the treatment works, how safe it is, and how long participants live. All participants will be followed for up to 5 years after the last person joins the study'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Have voluntarily agreed to provide written informed consent and demonstrated willingness and ability to comply with all aspects of the protocol.\n2. Males or females are ≥18 years of age, or per country adult legal age regulations, at the time of providing voluntary written informed consent.\n3. Life expectancy ≥3 months before enrollment.\n4. Meet requirement for hepatitis and human immunodeficiency virus (HIV) infection as follows\n\n * Negative serologic or polymerase chain reaction (PCR) test results for acute or chronic hepatitis B virus (HBV) infection Note: Participants whose HBV infection status could not be determined by serologic test results have to be negative for HBV-DNA by PCR to be eligible for study participation. Participants seropositive for HBV with undetectable HBV DNA by PCR are permitted with appropriate antiviral prophylaxis.\n * Negative test results for hepatitis C virus (HCV) Note: Participants who are positive for HCV antibody must be negative for HCV RNA by PCR to be eligible for study participation\n * If HIV positive, HIV infection is controlled. Based on Cancer Clinical Trial Eligibility Criteria: Patients with HIV, Hepatitis B Virus, or Hepatitis C Virus Infections - Guidance for Industry (https://www.fda.gov/media/121319/download), patients with HIV should be considered eligible if they have CD4+ T-cell counts ≥ 350 cells/uL and in general, if they have not had an opportunistic infection within the past 12 months. Other exclusion criteria should be considered regarding the drug-drug interaction if antiviral drugs are used. Therefore, in case of controlled HIV infection, since antiviral drugs are used, trial patients should be on established ART for at least 4 weeks and have an HIV viral load less than 400 copies/mL prior to enrolment.\n5. Have histologically confirmed FL, Grades 1 to 3A.\n6. Must have been previously treated with at least 1 prior systemic chemotherapy, immunotherapy, or chemoimmunotherapy:\n\n a. Systemic therapy includes treatments such as:\n\n i. Rituximab monotherapy\n\n ii. Chemotherapy given with or without rituximab\n\n iii. Radioimmunoconjugates such as 90Y-ibritumomab tiuxetan and 131I-tositumomab.\n\n b. Systemic therapy does not include, for example:\n\n i. Local involved field radiotherapy for limited-stage disease\n\n ii. Helicobacter pylori eradication\n\n c. Prior investigational therapies will be allowed provided the subject has received at least 1 prior systemic therapy as discussed in Inclusion Criterion #6a.\n\n d. Prior autologous/allogeneic hematopoietic stem cell transplant (HSCT) will be allowed.\n\n e. Prior chimeric antigen receptor T-cell therapy (CAR T) will be allowed.\n7. 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).\n8. Have measurable disease as defined by the Lugano Classification (Cheson, 2014; Appendix 5).\n9. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.\n10. Within 7 days prior to randomization, all clinically significant toxicity related to a prior anticancer treatment (ie, chemotherapy, immunotherapy, and/or radiotherapy must have either resolved to Grade 1 per NCI CTCAE Version 5.0 OR are clinically stable and no longer clinically significant.\n11. Have provided sufficient tumor tissue block or unstained slides for EZH2 mutation testing in all subjects to allow for stratification\n\n 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.\n\n 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.\n12. Time between prior anticancer therapy and first dose of tazemetostat as follows:\n\n 1. Cytotoxic chemotherapy - At least 21 days.\n 2. Noncytotoxic chemotherapy (eg, small molecule inhibitor) - At least 14 days.\n 3. Nitrosoureas - At least 6 weeks.\n 4. Monoclonal and/or bispecific antibodies or CAR T - At least 28 days.\n 5. Radiotherapy - At least 6 weeks from prior radioisotope therapy; at least 12 weeks from 50% pelvic or total body irradiation.\n13. Adequate renal function defined as calculated creatinine clearance ≥30 mL/minute per the Cockcroft and Gault formula.\n14. Adequate bone marrow function:\n\n 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\n * Without growth factor support (filgrastim or pegfilgrastim) for at least 14 days.\n\n b. Platelets ≥75,000/mm3 (≥75 × 10\\^9/L)\n * Evaluated at least 7 days after last platelet transfusion.\n\n c. Hemoglobin ≥9.0 g/dL\n * May receive transfusion\n15. Adequate liver function:\n\n 1. Total bilirubin ≤1.5 × the upper limit of normal (ULN) except for unconjugated hyperbilirubinemia of Gilbert's syndrome.\n 2. 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).\n16. 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.\n17. Females of childbearing potential (FCBP) must have a negative urine or serum pregnancy tests (beta-human chorionic gonadotropin \\[β-hCG\\] tests with a minimum sensitivity of 25 mIU/mL or equivalent units of β-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 childbearing potential\\] and without other known or suspected cause) or have been sterilized surgically (ie, total hysterectomy and/or bilateral oophorectomy, with surgery completed at least 1 month before dosing).\n18. 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. Contraception must begin at least 28 days prior to first dose of study drug, continue during study treatment (including during dose interruptions), and for 12 months after study drug discontinuation. Female subjects must also refrain from breastfeeding for 12 months following last dose of study drug. If the below contraception methods are not appropriate for the FCBP, she must be referred to a qualified contraception provider to determine the medically effective contraception method appropriate for the subject. The following are examples of highly effective and additional effective methods of contraception:\n\n Examples of highly effective methods:\n * Intrauterine device (IUD)\n * Hormonal (ovulation inhibitory combined \\[estrogen and progesterone\\] birth control pills or intravaginal/transdermal system, injections, implants, levonorgestrel-releasing intrauterine system \\[IUS\\], medroxyprogesterone acetate depot injections, ovulation inhibitory progesterone-only pills \\[e.g. desogestrel\\]) NOTE: There is a potential for tazemetostat interference with hormonal contraception methods due to enzymatic induction.\n * Bilateral tubal ligation\n * Partner's vasectomy (if medically confirmed \\[azoospermia\\] and sole sexual partner).\n\n Examples of additional effective methods:\n * Male latex or synthetic condom,\n * Diaphragm,\n * Cervical Cap\n\n NOTE: Female subjects of childbearing potential exempt from these contraception requirements are subjects who practice complete abstinence from heterosexual sexual contact. True abstinence is acceptable when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (eg, calendar, ovulation, symptothermal, or post ovulation methods) and withdrawal are not acceptable methods of contraception.\n19. All study participants enrolled must be registered into the applicable pregnancy prevention program (e.g. REVLIMID REMS in the US, Pregnancy Prevention Programme \\[PPP\\] in Europe) for lenalidomide to be administered and be willing and able to comply with the requirements of the applicable program as appropriate for the country in which the drug is being used.\n\n a. Female subjects of childbearing potential (FCBP) must adhere to the scheduled pregnancy testing as required in theapplicable pregnancy prevention program. During study treatment, FCBP must agree to have pregnancy testing weekly for the first 28 days of study participation and then every 28 days for FCBP with regular or no menstrual cycles OR every 14 days for FCBP with irregular menstrual cycles. FCBP must also have a pregnancy test at end of lenalidomide treatment, at day 14 (for FCBP with irregular menstrual cycles) and day 28 following the last dose of lenalidomide and at overall treatment discontinuation (at the End-of-Treatment/30-day safety Follow-up visit). Female subjects exempt from this requirement are subjects who have been naturally postmenopausal for at least 24 consecutive months OR are surgically sterilized (ie, total hysterectomy or bilateral oophorectomy) with surgery at least 1 month before the first dose of study treatment.\n20. Male subjects must either practice complete abstinence or agree to use a latex or synthetic condom, even with a successful vasectomy (medically confirmed azoospermia), during sexual contact with a pregnant female or FCBP from first dose of study drug, during study treatment (including during dose interruptions), and for 3 months after study drug discontinuation.\n\nNOTE: Male subjects must not donate semen or sperm from first dose of study drug, during study treatment (including during dose interruptions), and for 3 months after study drug discontinuation.\n\nExclusion Criteria:\n\nAll Subjects\n\n1. Prior exposure to tazemetostat or other inhibitor(s) of EZH2.\n2. Prior exposure to lenalidomide or drugs of the same class.\n3. 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).\n4. 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).\n5. Has a prior history of T-cell lymphoblastic lymphoma (T-LBL)/T-cell acute lymphoblastic leukemia (T-ALL) or B-cell acute lymphoblastic leukemia (B-ALL).\n6. Subjects with uncontrolled leptomeningeal metastases or brain metastases or history of previously treated brain metastases.\n7. Subjects taking medications that are known strong CYP3A inhibitors and strong or moderate CYP3A inducers (including St. John's wort).\n8. Are unwilling to exclude grapefruit juice, Seville oranges, and grapefruits from the diet and/or consumed within 1 week of the first dose of study drug and for the duration of the study.\n9. Major surgery within 4 weeks before the first dose of study drug.\n\n a. Note: Minor surgery (eg, minor biopsy of extracranial site, central venous catheter placement, shunt revision) is permitted within 3 weeks prior to enrollment.\n10. 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.\n11. 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.\n12. Prolongation of corrected QT interval using Fridericia's formula (QTcF) to ≥480 msec at screening or history of long QT syndrome.\n13. Venous thrombosis or pulmonary embolism within the last 3 months before starting tazemetostat.\n\n 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.\n14. Have an active infection requiring systemic therapy.\n15. Known hypersensitivity to any component of tazemetostat or lenalidomide; known severe hypersensitivity to any component of rituximab requiring hospitalization or resuscitation.\n16. 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.\n\n 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.\n17. 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.\n\n NOTE: Subjects with a history of hepatitis C infection (HCV antibody reactive) who have normal ALT and undetectable HCV RNA are eligible.\n18. 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.\n19. Female subjects who are pregnant or lactating/breastfeeding.\n20. Subjects who have undergone a solid organ transplant.\n21. 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."}, 'identificationModule': {'nctId': 'NCT04224493', 'acronym': 'SYMPHONY-1', 'briefTitle': 'A Study to Assess the Efficacy, Safety, Pharmacodynamics, and Pharmacokinetics of Tazemetostat in Combination With Lenalidomide Plus Rituximab Versus Placebo in Combination With Lenalidomide Plus Rituximab in Adult Patients at Least 18 Years of Age With Relapsed/Refractory Follicular Lymphoma.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ipsen'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'EZH-302'}, 'secondaryIdInfos': [{'id': '2019-003333-42', 'type': 'EUDRACT_NUMBER'}, {'id': '2024-510690-16-00', 'type': 'CTIS'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tazemetostat + R2 arm', 'description': 'Stage 1 (Phase 1b): This phase is now completed.\n\n* Tazemetostat was escalated from a starting dose of 400 mg PO twice daily to 600 mg PO twice daily to 800 mg PO twice daily in 28-day cycles.\n* Rituximab 375 mg/m2 IV on days 1, 8, 15, and 22 of cycle 1; then on day 1 of cycles 2 to 5.\n* Lenalidomide 20 mg or 10 mg (if creatinine clearance ≥60 mL/minute or \\<60 mL/minute), administred PO QD on days 1 to 21 for 12 cycles.\n\nStage 2:\n\n* Tazemetostat 800 mg administered PO twice daily in continuous 28-day cycles.\n* Rituximab 375 mg/m2 IV on days 1, 8, 15, and 22 of cycle 1; then on day 1 of cycles 2 to 5.\n* Lenalidomide 20 mg or 10 mg (if creatinine clearance ≥60 mL/minute or \\<60 mL/minute), PO QD on days 1 to 21 for 12 cycles.\n\nMaintenance Therapy (Stages 1 and 2):\n\nTazemetostat will be administered as monotherapy at an 800 mg twice daily dose for up to 2 years after the initial 12 months of combination therapy.', 'interventionNames': ['Drug: Tazemetostat', 'Combination Product: Lenalidomide', 'Combination Product: Rituximab']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo + R2 Arm', 'description': 'Stage 2:\n\n* Placebo administered PO twice daily in continuous 28-day cycles.\n* Rituximab 375 mg/m2 IV on days 1, 8, 15, and 22 of cycle 1; then on day 1 of cycles 2 to 5.\n* Lenalidomide 20 mg or 10 mg (if creatinine clearance ≥60 mL/minute or \\<60 mL/minute), administered PO QD on days 1 to 21 for 12 cycles.\n\nMaintenance Therapy (Stage 2):\n\nPlacebo will be administered as monotherapy twice daily dose for up to 2 years after the initial 12 months of combination therapy. During maintenance, placebo will be continued until disease progression or unacceptable toxicity, or participant withdraws consent.', 'interventionNames': ['Drug: Placebo oral tablet', 'Combination Product: Lenalidomide', 'Combination Product: Rituximab']}], 'interventions': [{'name': 'Tazemetostat', 'type': 'DRUG', 'otherNames': ['EPZ-6438', 'IPN60200'], 'description': 'Stage 1 (Phase 1b):\n\nTazemetostat was escalated from a starting dose of 400 mg orally twice daily to 600 mg orally twice daily to 800 mg PO twice daily in 28-day cycles as tolerated in a standard 3 + 3 design. Tazemetostat will be administered as monotherapy at an 800 mg twice daily dose for up to 2 years after the initial 12 months of combination therapy.', 'armGroupLabels': ['Tazemetostat + R2 arm']}, {'name': 'Tazemetostat', 'type': 'DRUG', 'otherNames': ['EPZ-6438', 'IPN60200'], 'description': 'Stage 2:\n\nTazemetostat 800 mg administered orally twice daily in continuous 28-day cycles for 12 cycles. Tazemetostat will be administered as monotherapy at an 800 mg twice daily dose for up to 2 years after the initial 12 months of combination therapy.', 'armGroupLabels': ['Tazemetostat + R2 arm']}, {'name': 'Placebo oral tablet', 'type': 'DRUG', 'description': 'Stage 2:\n\nPlacebo administered orally twice daily in continuous 28-day cycles. Placebo will be administered as monotherapy twice daily dose for up to 2 years after the initial 12 months of combination therapy.', 'armGroupLabels': ['Placebo + R2 Arm']}, {'name': 'Lenalidomide', 'type': 'COMBINATION_PRODUCT', 'description': 'Lenalidomide 20 mg capsules or 10 mg capsules (if creatinine clearance ≥60 mL/minute or \\<60 mL/minute), administered PO QD on days 1 to 21 for 12 cycles.', 'armGroupLabels': ['Placebo + R2 Arm', 'Tazemetostat + R2 arm']}, {'name': 'Rituximab', 'type': 'COMBINATION_PRODUCT', 'description': 'Rituximab 375 mg/m2 IV on days 1, 8, 15, and 22 of cycle 1; then on day 1 of cycles 2 to 5.', 'armGroupLabels': ['Placebo + R2 Arm', 'Tazemetostat + R2 arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36608', 'city': 'Mobile', 'state': 'Alabama', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Michael Meshad, MD', 'role': 'CONTACT'}], 'facility': 'Southern Cancer Center', 'geoPoint': {'lat': 30.69436, 'lon': -88.04305}}, {'zip': '85704', 'city': 'Tucson', 'state': 'Arizona', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Sudhir Manda, MD', 'role': 'CONTACT'}], 'facility': 'Arizona Oncology Associates - Tuscon-Rusadill Road', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '90703', 'city': 'Cerritos', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Omkar Marathe, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'TOI - Clinical Research', 'geoPoint': {'lat': 33.85835, 'lon': -118.06479}}, {'zip': '93611', 'city': 'Clovis', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Haifaa Abdulhaq, MD', 'role': 'CONTACT'}], 'facility': 'UCSF Fresno', 'geoPoint': {'lat': 36.82523, 'lon': -119.70292}}, {'zip': '92093', 'city': 'La Jolla', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Benjamin Heyman', 'role': 'CONTACT'}], 'facility': 'UC San Diego Health Sciences', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '90404', 'city': 'Santa Monica', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Sven De Vos, MD', 'role': 'CONTACT'}], 'facility': 'UCLA Clinical Research Unit Hematology/Oncology', 'geoPoint': {'lat': 34.01949, 'lon': -118.49138}}, {'zip': '80303', 'city': 'Boulder', 'state': 'Colorado', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'David Andorsky, MD', 'role': 'CONTACT'}], 'facility': 'Rocky Mountain Cancer Centers (RMCC) - Boulder', 'geoPoint': {'lat': 40.01499, 'lon': -105.27055}}, {'zip': '81501', 'city': 'Grand Junction', 'state': 'Colorado', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kyle Work, MD', 'role': 'CONTACT'}], 'facility': "St. Mary's Hospital and Regional Medical Center - St. Mary's", 'geoPoint': {'lat': 39.06387, 'lon': -108.55065}}, {'zip': '80033', 'city': 'Greeley', 'state': 'Colorado', 'status': 'WITHDRAWN', 'country': 'United States', 'facility': 'SCL Health Lutheran Medical Center', 'geoPoint': {'lat': 40.42331, 'lon': -104.70913}}, {'zip': '32003', 'city': 'Fleming Island', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Mehdi M Moezi, MD', 'role': 'CONTACT'}], 'facility': 'Cancer Specialists of North Florida', 'geoPoint': {'lat': 30.0933, 'lon': -81.71898}}, {'zip': '33908', 'city': 'Fort Myers', 'state': 'Florida', 'status': 'TERMINATED', 'country': 'United States', 'facility': 'Florida Cancer Specialists & Research Institute (FCS) - Fort Myers Cancer Center', 'geoPoint': {'lat': 26.62168, 'lon': -81.84059}}, {'zip': '32224', 'city': 'Jacksonville', 'state': 'Florida', 'status': 'WITHDRAWN', 'country': 'United States', 'facility': 'Mayo Clinic - Cancer Clinical Research Office', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '32224', 'city': 'Jacksonville', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Tan Han, MD', 'role': 'CONTACT'}], 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '33176', 'city': 'Miami', 'state': 'Florida', 'status': 'WITHDRAWN', 'country': 'United States', 'facility': 'Miami Cancer Institute', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '34474', 'city': 'Ocala', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Ketan Doshi, MD', 'role': 'CONTACT'}], 'facility': 'Florida Cancer Affiliates/Ocala Oncology - Clinic', 'geoPoint': {'lat': 29.1872, 'lon': -82.14009}}, {'zip': '33322', 'city': 'Plantation', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jason Tache, MD', 'role': 'CONTACT'}], 'facility': 'BRCR Medical Center, INC', 'geoPoint': {'lat': 26.13421, 'lon': -80.23184}}, {'zip': '33705', 'city': 'St. Petersburg', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Sunil Gandhi, MD', 'role': 'CONTACT'}], 'facility': 'Florida Cancer Specialists', 'geoPoint': {'lat': 27.77086, 'lon': -82.67927}}, {'zip': '32308', 'city': 'Tallahassee', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Viralkumar Bhanderi', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Florida Cancer Specialists - Panhandle', 'geoPoint': {'lat': 30.43826, 'lon': -84.28073}}, {'zip': '33612', 'city': 'Tampa', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Sameh Gaballa, MD', 'role': 'CONTACT'}], 'facility': 'H Lee Moffitt Cancer Center and Research Institute I', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '33401', 'city': 'West Palm Beach', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Shachar Peles, MD', 'role': 'CONTACT'}], 'facility': 'Florida Cancer Specialists & Research Institute (FCS) - Atlantis', 'geoPoint': {'lat': 26.71534, 'lon': -80.05337}}, {'zip': '96819', 'city': 'Honolulu', 'state': 'Hawaii', 'status': 'WITHDRAWN', 'country': 'United States', 'facility': 'Kaiser Permanente Hawaii Moanalua Medical Center', 'geoPoint': {'lat': 21.30694, 'lon': -157.85833}}, {'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Sonali Smith, MD', 'role': 'CONTACT'}], 'facility': 'University of Chicago', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60714', 'city': 'Niles', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Leonard Klein, MD', 'role': 'CONTACT'}], 'facility': 'Illinois Cancer Specialists', 'geoPoint': {'lat': 42.01892, 'lon': -87.80284}}, {'zip': '51101', 'city': 'Sioux City', 'state': 'Iowa', 'status': 'WITHDRAWN', 'country': 'United States', 'facility': 'June E. Nylen Cancer Center', 'geoPoint': {'lat': 42.49999, 'lon': -96.40031}}, {'zip': '66210', 'city': 'Overland Park', 'state': 'Kansas', 'status': 'WITHDRAWN', 'country': 'United States', 'facility': 'The University of Kansas Cancer Center', 'geoPoint': {'lat': 38.98223, 'lon': -94.67079}}, {'zip': '21201', 'city': 'Baltimore', 'state': 'Maryland', 'status': 'WITHDRAWN', 'country': 'United States', 'facility': 'University of Maryland', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '20815-6908', 'city': 'Chevy Chase', 'state': 'Maryland', 'status': 'WITHDRAWN', 'country': 'United States', 'facility': 'The office of Frederick P. Smith, MD, P.C.', 'geoPoint': {'lat': 39.00287, 'lon': -77.07115}}, {'zip': '02462', 'city': 'Newton', 'state': 'Massachusetts', 'status': 'WITHDRAWN', 'country': 'United States', 'facility': 'Mass General Cancer Center at Newton-Wellesley', 'geoPoint': {'lat': 42.33704, 'lon': -71.20922}}, {'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Sano Dahlia, MD', 'role': 'CONTACT'}], 'facility': 'University of Michigan Comprehensive Cancer Center', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '48197', 'city': 'Ypsilanti', 'state': 'Michigan', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Christopher Reynolds, MD', 'role': 'CONTACT'}], 'facility': 'St. Joseph Mercy Hospital', 'geoPoint': {'lat': 42.24115, 'lon': -83.61299}}, {'zip': '55901', 'city': 'Rochester', 'state': 'Minnesota', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jose C Villasboas Bisneto, MD', 'role': 'CONTACT'}], 'facility': 'Mayo Clinic - Rochester', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'status': 'WITHDRAWN', 'country': 'United States', 'facility': 'Saint Louis University Cancer Center', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '68198', 'city': 'Omaha', 'state': 'Nebraska', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Julie Vose, MD', 'role': 'CONTACT'}], 'facility': 'University Of Nebraska Medical Center', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '08816', 'city': 'East Brunswick', 'state': 'New Jersey', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Bruno Fang, MD', 'role': 'CONTACT'}], 'facility': 'Astera Cancer Care', 'geoPoint': {'lat': 40.42788, 'lon': -74.41598}}, {'zip': '08816', 'city': 'East Brunswick', 'state': 'New Jersey', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Bruno Fang, MD', 'role': 'CONTACT'}], 'facility': 'Astera Cancer Center', 'geoPoint': {'lat': 40.42788, 'lon': -74.41598}}, {'zip': '07728', 'city': 'Freehold', 'state': 'New Jersey', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Nandini Ignatius, MD', 'role': 'CONTACT'}], 'facility': 'Regional Cancer Care Associates-Freehold', 'geoPoint': {'lat': 40.26011, 'lon': -74.27376}}, {'zip': '07601', 'city': 'Hackensack', 'state': 'New Jersey', 'status': 'WITHDRAWN', 'country': 'United States', 'facility': 'Hackensack University Medical John Theurer Cancer Center', 'geoPoint': {'lat': 40.88593, 'lon': -74.04347}}, {'zip': '07731', 'city': 'Howell Township', 'state': 'New Jersey', 'status': 'WITHDRAWN', 'country': 'United States', 'facility': 'Regional Cancer Care Associates LLC - Howell', 'geoPoint': {'lat': 40.1645, 'lon': -74.20834}}, {'zip': '07739', 'city': 'Little Silver', 'state': 'New Jersey', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Ian Horkheimer, MD', 'role': 'CONTACT'}], 'facility': 'Regional Cancer Care Associates LLC - Little Silver', 'geoPoint': {'lat': 40.33678, 'lon': -74.04708}}, {'zip': '87131-0001', 'city': 'Albuquerque', 'state': 'New Mexico', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Leslie Andritsos, MD', 'role': 'CONTACT'}], 'facility': 'New Mexico Cancer Care Alliance', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}, {'zip': '12206', 'city': 'Albany', 'state': 'New York', 'status': 'WITHDRAWN', 'country': 'United States', 'facility': 'New York Oncology Hematology, P.C.', 'geoPoint': {'lat': 42.65258, 'lon': -73.75623}}, {'zip': '11042', 'city': 'Lake Success', 'state': 'New York', 'status': 'WITHDRAWN', 'country': 'United States', 'facility': 'Northwell Health/Monter Cancer Center', 'geoPoint': {'lat': 40.77066, 'lon': -73.71763}}, {'zip': '10021', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'John P Leonard, MD', 'role': 'CONTACT'}], 'facility': 'Weill Cornell Medicine-New York Presbyterian Hospital', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jennifer Amengual, MD', 'role': 'CONTACT'}], 'facility': 'Columbia U - Herbert Irving Comprehensive Cancer Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10065', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Salles Gilles, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Memorial Sloan-Kettering Cancer Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10960', 'city': 'Nyack', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Sung Ho Lee, MD', 'role': 'CONTACT'}], 'facility': 'Hematology Oncology Associates of Rockland, P.C.', 'geoPoint': {'lat': 41.09065, 'lon': -73.91791}}, {'zip': '28806', 'city': 'Asheville', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Christopher Chay, MD', 'role': 'CONTACT'}], 'facility': 'Messino Cancer Center', 'geoPoint': {'lat': 35.60095, 'lon': -82.55402}}, {'zip': '28205', 'city': 'Concord', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Steven Park, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Levine Cancer Institute - Concord', 'geoPoint': {'lat': 35.40888, 'lon': -80.58158}}, {'zip': '28374', 'city': 'Pinehurst', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Charles Kuzma, MD', 'role': 'CONTACT'}], 'facility': 'FirstHealth of the Carolinas', 'geoPoint': {'lat': 35.19543, 'lon': -79.46948}}, {'zip': '27895', 'city': 'Wilson', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Regional Medical Oncology Center', 'geoPoint': {'lat': 35.72127, 'lon': -77.91554}}, {'zip': '44718', 'city': 'Canton', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Nashat Gabrail, MD', 'role': 'CONTACT'}], 'facility': 'Gabrail Cancer Center Research', 'geoPoint': {'lat': 40.79895, 'lon': -81.37845}}, {'zip': '45236', 'city': 'Cincinnati', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Miguel Islas-Ohlmayer, MD', 'role': 'CONTACT'}, {'name': 'Patel Ameet', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Oncology Hematology Care (OHC), Inc. - Kenwood Office', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '97401', 'city': 'Eugene', 'state': 'Oregon', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jeffrey Sharman, MD', 'role': 'CONTACT'}], 'facility': 'Willamette Valley Cancer Institute and Research Center - Oncology', 'geoPoint': {'lat': 44.05207, 'lon': -123.08675}}, {'zip': '15232', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'status': 'WITHDRAWN', 'country': 'United States', 'facility': 'University of Pittsburgh Medical Center - Oncology', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '15524', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Cyrus M Khan, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Western Pennsylvania Hospital Hematology & Cellular Therapy', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '37404', 'city': 'Chattanooga', 'state': 'Tennessee', 'status': 'WITHDRAWN', 'country': 'United States', 'facility': 'Tennessee Oncology, PLLC', 'geoPoint': {'lat': 35.04563, 'lon': -85.30968}}, {'zip': '37920', 'city': 'Knoxville', 'state': 'Tennessee', 'status': 'WITHDRAWN', 'country': 'United States', 'facility': 'University of Tennessee Medical Center - 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