Ignite Creation Date:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2025-12-25 @ 10:25 PM
Study NCT ID:
NCT05011058
Status:
TERMINATED
Last Update Posted:
2025-07-28
First Post:
2021-08-02
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
An Open-Label Phase 2 Trial of Nanatinostat Plus Valganciclovir in Patients With EBV+ Relapsed/Refractory Lymphomas
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Hong Kong'], 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2025-04-18', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D046248', 'term': 'Pyloric Stenosis, Hypertrophic'}, {'id': 'D020031', 'term': 'Epstein-Barr Virus Infections'}], 'ancestors': [{'id': 'D011707', 'term': 'Pyloric Stenosis'}, {'id': 'D017219', 'term': 'Gastric Outlet Obstruction'}, {'id': 'D013272', 'term': 'Stomach Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D006566', 'term': 'Herpesviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014412', 'term': 'Tumor Virus Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077562', 'term': 'Valganciclovir'}], 'ancestors': [{'id': 'D015774', 'term': 'Ganciclovir'}, {'id': 'D000212', 'term': 'Acyclovir'}, {'id': 'D006147', 'term': 'Guanine'}, {'id': 'D007042', 'term': 'Hypoxanthines'}, {'id': 'D011688', 'term': 'Purinones'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials@Viracta.com', 'phone': '858-400-8470', 'title': 'Dr. Darrel Cohen', 'organization': 'Viracta Therapeutics'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'The study was terminated prematurely.'}}, 'adverseEventsModule': {'timeFrame': 'Up to approximately 3 years for All-Cause Mortality; Up to approximately 2 years for Serious Adverse Events and Other (Not Including Serious) Adverse Events', 'eventGroups': [{'id': 'EG000', 'title': 'Diffuse Large B-Cell Lymphoma', 'description': 'Patients with relapsed or refractory EBV-positive diffuse large B-cell lymphoma treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD', 'otherNumAtRisk': 9, 'deathsNumAtRisk': 9, 'otherNumAffected': 9, 'seriousNumAtRisk': 9, 'deathsNumAffected': 3, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': 'Extranodal Natural Killer/T-Cell Lymphoma', 'description': 'Patients with relapsed or refractory EBV-positive extranodal natural killer/T-cell lymphoma treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD', 'otherNumAtRisk': 11, 'deathsNumAtRisk': 11, 'otherNumAffected': 10, 'seriousNumAtRisk': 11, 'deathsNumAffected': 9, 'seriousNumAffected': 7}, {'id': 'EG002', 'title': 'Peripheral T-Cell Lymphoma (Combination Therapy)', 'description': 'Patients with relapsed or refractory EBV-positive angioimmunoblastic T-cell lymphoma or peripheral T-cell lymphoma not otherwise specified treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD', 'otherNumAtRisk': 38, 'deathsNumAtRisk': 38, 'otherNumAffected': 32, 'seriousNumAtRisk': 38, 'deathsNumAffected': 9, 'seriousNumAffected': 9}, {'id': 'EG003', 'title': 'Peripheral T-Cell Lymphoma (Monotherapy)', 'description': 'Patients with relapsed or refractory EBV-positive angioimmunoblastic T-cell lymphoma or peripheral T-cell lymphoma not otherwise specified treated with nanatinostat 20 mg QD on Days 1 to 4 per week', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 10, 'seriousNumAtRisk': 10, 'deathsNumAffected': 4, 'seriousNumAffected': 5}, {'id': 'EG004', 'title': 'Peripheral T-Cell Lymphoma (Crossover)', 'description': 'Patients with relapsed or refractory EBV-positive angioimmunoblastic T-cell lymphoma or peripheral T-cell lymphoma not otherwise specified treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD after having been treated with nanatinostat 20 mg QD on Days 1 to 4 per week without response in the monotherapy cohort', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 5, 'seriousNumAtRisk': 5, 'deathsNumAffected': 2, 'seriousNumAffected': 3}, {'id': 'EG005', 'title': 'Hodgkin Lymphoma', 'description': 'Patients with relapsed or refractory EBV-positive Hodgkin lymphoma treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 7, 'seriousNumAtRisk': 8, 'deathsNumAffected': 3, 'seriousNumAffected': 2}, {'id': 'EG006', 'title': 'Post-Transplant Lymphoproliferative Disorders', 'description': 'Patients with relapsed or refractory EBV-positive post-transplant lymphoproliferative disorders treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'deathsNumAffected': 1, 'seriousNumAffected': 3}, {'id': 'EG007', 'title': 'Human Immunodeficiency Virus-Associated Lymphomas', 'description': 'Patients with relapsed or refractory EBV-positive human immunodeficiency virus-associated lymphomas treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'deathsNumAffected': 1, 'seriousNumAffected': 2}, {'id': 'EG008', 'title': 'Other EBV-Positive Lymphomas', 'description': 'Patients with relapsed or refractory EBV-positive lymphomas other than those from the other cohorts treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 17, 'seriousNumAtRisk': 20, 'deathsNumAffected': 8, 'seriousNumAffected': 10}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 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'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 20, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}, 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'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Objective Response Rate (ORR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '20', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Diffuse Large B-Cell Lymphoma', 'description': 'Patients with relapsed or refractory EBV-positive diffuse large B-cell lymphoma treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD'}, {'id': 'OG001', 'title': 'Extranodal Natural Killer/T-Cell Lymphoma', 'description': 'Patients with relapsed or refractory EBV-positive extranodal natural killer/T-cell lymphoma treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD'}, {'id': 'OG002', 'title': 'Peripheral T-Cell Lymphoma (Combination Therapy)', 'description': 'Patients with relapsed or refractory EBV-positive angioimmunoblastic T-cell lymphoma or peripheral T-cell lymphoma not otherwise specified treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD'}, {'id': 'OG003', 'title': 'Peripheral T-Cell Lymphoma (Monotherapy)', 'description': 'Patients with relapsed or refractory EBV-positive angioimmunoblastic T-cell lymphoma or peripheral T-cell lymphoma not otherwise specified treated with nanatinostat 20 mg QD on Days 1 to 4 per week'}, {'id': 'OG004', 'title': 'Hodgkin Lymphoma', 'description': 'Patients with relapsed or refractory EBV-positive Hodgkin lymphoma treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD'}, {'id': 'OG005', 'title': 'Post-Transplant Lymphoproliferative Disorders', 'description': 'Patients with relapsed or refractory EBV-positive post-transplant lymphoproliferative disorders treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD'}, {'id': 'OG006', 'title': 'Human Immunodeficiency Virus-Associated Lymphomas', 'description': 'Patients with relapsed or refractory EBV-positive human immunodeficiency virus-associated lymphomas treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD'}, {'id': 'OG007', 'title': 'Other EBV-Positive Lymphomas', 'description': 'Patients with relapsed or refractory EBV-positive lymphomas other than those from the other cohorts treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to approximately 2 years', 'description': 'Number (percentage) of patients with a best overall complete response (CR) or partial response (PR) according to the 2007 International Working Group (IWG) criteria, where CR included complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy with all lymph nodes and nodal masses having regressed on computed tomography to normal size, and PR included at least a 50% decrease in sum of the product of the diameters (SPD) of up to six of the largest dominant nodes or nodal masses, no increase should have been observed in the size of other nodes, liver, or spleen, and splenic and hepatic nodules must have regressed by ≥ 50% in their SPD or, for single nodules, in the greatest transverse diameter.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat Analysis Set, defined as all patients who were enrolled into the trial regardless of whether or not they received study treatment.\n\nThe study was not designed to make formal statistical comparisons of ORRs between cohorts.'}, {'type': 'SECONDARY', 'title': 'Duration of Response (DOR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Diffuse Large B-Cell Lymphoma', 'description': 'Patients with relapsed or refractory EBV-positive diffuse large B-cell lymphoma treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD'}, {'id': 'OG001', 'title': 'Extranodal Natural Killer/T-Cell Lymphoma', 'description': 'Patients with relapsed or refractory EBV-positive extranodal natural killer/T-cell lymphoma treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD'}, {'id': 'OG002', 'title': 'Peripheral T-Cell Lymphoma (Combination Therapy)', 'description': 'Patients with relapsed or refractory EBV-positive angioimmunoblastic T-cell lymphoma or peripheral T-cell lymphoma not otherwise specified treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD'}, {'id': 'OG003', 'title': 'Peripheral T-Cell Lymphoma (Monotherapy)', 'description': 'Patients with relapsed or refractory EBV-positive angioimmunoblastic T-cell lymphoma or peripheral T-cell lymphoma not otherwise specified treated with nanatinostat 20 mg QD on Days 1 to 4 per week'}, {'id': 'OG004', 'title': 'Hodgkin Lymphoma', 'description': 'Patients with relapsed or refractory EBV-positive Hodgkin lymphoma treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD'}, {'id': 'OG005', 'title': 'Post-Transplant Lymphoproliferative Disorders', 'description': 'Patients with relapsed or refractory EBV-positive post-transplant lymphoproliferative disorders treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD'}, {'id': 'OG006', 'title': 'Human Immunodeficiency Virus-Associated Lymphomas', 'description': 'Patients with relapsed or refractory EBV-positive human immunodeficiency virus-associated lymphomas treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD'}, {'id': 'OG007', 'title': 'Other EBV-Positive Lymphomas', 'description': 'Patients with relapsed or refractory EBV-positive lymphomas other than those from the other cohorts treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD'}], 'classes': [{'categories': [{'measurements': [{'value': '98', 'groupId': 'OG002', 'lowerLimit': '29', 'upperLimit': '340'}, {'value': '43', 'groupId': 'OG003', 'lowerLimit': '43', 'upperLimit': '43'}, {'value': '163.5', 'groupId': 'OG007', 'lowerLimit': '86', 'upperLimit': '241'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to approximately 2 years', 'description': 'Interval of time from date of first observed complete or partial response per 2007 International Working Group (IWG) criteria to the date of documented disease progression or death due to any cause, where disease progression is defined by 2007 IWG criteria as any new lesion or increase by ≥ 50% of previously involved sites from nadir. DOR was censored at the time of study withdrawal for hematopoietic stem cell transplant, or at the time of study termination, whichever was earlier, for patients whose disease was still in response.', 'unitOfMeasure': 'days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients who achieved a CR or PR. The study was not designed to make formal statistical comparisons of DOR between cohorts.'}, {'type': 'SECONDARY', 'title': 'Time to Next Anti-Lymphoma Treatment (TTNLT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Diffuse Large B-Cell Lymphoma', 'description': 'Patients with relapsed or refractory EBV-positive diffuse large B-cell lymphoma treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD'}, {'id': 'OG001', 'title': 'Extranodal Natural Killer/T-Cell Lymphoma', 'description': 'Patients with relapsed or refractory EBV-positive extranodal natural killer/T-cell lymphoma treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD'}, {'id': 'OG002', 'title': 'Peripheral T-Cell Lymphoma (Combination Therapy)', 'description': 'Patients with relapsed or refractory EBV-positive angioimmunoblastic T-cell lymphoma or peripheral T-cell lymphoma not otherwise specified treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD'}, {'id': 'OG003', 'title': 'Peripheral T-Cell Lymphoma (Monotherapy)', 'description': 'Patients with relapsed or refractory EBV-positive angioimmunoblastic T-cell lymphoma or peripheral T-cell lymphoma not otherwise specified treated with nanatinostat 20 mg QD on Days 1 to 4 per week'}, {'id': 'OG004', 'title': 'Hodgkin Lymphoma', 'description': 'Patients with relapsed or refractory EBV-positive Hodgkin lymphoma treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD'}, {'id': 'OG005', 'title': 'Post-Transplant Lymphoproliferative Disorders', 'description': 'Patients with relapsed or refractory EBV-positive post-transplant lymphoproliferative disorders treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD'}, {'id': 'OG006', 'title': 'Human Immunodeficiency Virus-Associated Lymphomas', 'description': 'Patients with relapsed or refractory EBV-positive human immunodeficiency virus-associated lymphomas treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD'}, {'id': 'OG007', 'title': 'Other EBV-Positive Lymphomas', 'description': 'Patients with relapsed or refractory EBV-positive lymphomas other than those from the other cohorts treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD'}], 'timeFrame': 'Up to approximately 3 years', 'description': 'Interval of time from the start of study drug treatment to the date of next anti-lymphoma treatment (including chemotherapy, radiotherapy, radioimmunotherapy, or immunotherapy).', 'reportingStatus': 'POSTED', 'populationDescription': 'The clinical trial was terminated before the outcome measure data were collected (data export from the clinical database just prior to study termination retrieved from data manager files contained data listings to support determinations of other secondary efficacy outcome measures but not post-treatment anticancer therapy regimen dates to support TTNLT determination, and investigation into the cause of these uncollected data was preempted by sponsor company closure soon after study termination).'}, {'type': 'SECONDARY', 'title': 'Time to Progression (TTP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '20', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Diffuse Large B-Cell Lymphoma', 'description': 'Patients with relapsed or refractory EBV-positive diffuse large B-cell lymphoma treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD'}, {'id': 'OG001', 'title': 'Extranodal Natural Killer/T-Cell Lymphoma', 'description': 'Patients with relapsed or refractory EBV-positive extranodal natural killer/T-cell lymphoma treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD'}, {'id': 'OG002', 'title': 'Peripheral T-Cell Lymphoma (Combination Therapy)', 'description': 'Patients with relapsed or refractory EBV-positive angioimmunoblastic T-cell lymphoma or peripheral T-cell lymphoma not otherwise specified treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD'}, {'id': 'OG003', 'title': 'Peripheral T-Cell Lymphoma (Monotherapy)', 'description': 'Patients with relapsed or refractory EBV-positive angioimmunoblastic T-cell lymphoma or peripheral T-cell lymphoma not otherwise specified treated with nanatinostat 20 mg QD on Days 1 to 4 per week'}, {'id': 'OG004', 'title': 'Hodgkin Lymphoma', 'description': 'Patients with relapsed or refractory EBV-positive Hodgkin lymphoma treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD'}, {'id': 'OG005', 'title': 'Post-Transplant Lymphoproliferative Disorders', 'description': 'Patients with relapsed or refractory EBV-positive post-transplant lymphoproliferative disorders treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD'}, {'id': 'OG006', 'title': 'Human Immunodeficiency Virus-Associated Lymphomas', 'description': 'Patients with relapsed or refractory EBV-positive human immunodeficiency virus-associated lymphomas treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD'}, {'id': 'OG007', 'title': 'Other EBV-Positive Lymphomas', 'description': 'Patients with relapsed or refractory EBV-positive lymphomas other than those from the other cohorts treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD'}], 'classes': [{'categories': [{'measurements': [{'value': '81', 'groupId': 'OG000', 'lowerLimit': '29', 'upperLimit': '165'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '23', 'upperLimit': '260'}, {'value': '124', 'groupId': 'OG002', 'lowerLimit': '14', 'upperLimit': '410'}, {'value': '95', 'groupId': 'OG003', 'lowerLimit': '32', 'upperLimit': '136'}, {'value': '77.5', 'groupId': 'OG004', 'lowerLimit': '64', 'upperLimit': '127'}, {'value': '79', 'groupId': 'OG005', 'lowerLimit': '36', 'upperLimit': '351'}, {'value': '108', 'groupId': 'OG006', 'lowerLimit': '64', 'upperLimit': '282'}, {'value': '95.5', 'groupId': 'OG007', 'lowerLimit': '35', 'upperLimit': '311'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to approximately 3 years', 'description': 'Interval of time from the start of study drug treatment to the date of disease progression, where disease progression is defined by 2007 IWG criteria as any new lesion or increase by ≥ 50% of previously involved sites from nadir. TTP was censored at the time of study withdrawal for hematopoietic stem cell transplant, at the time of study treatment withdrawal (or at the time of crossover from monotherapy to combination therapy), or at the time of study termination, whichever was earliest, for patients without reported disease progression.', 'unitOfMeasure': 'days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat Analysis Set, defined as all patients who were enrolled into the trial regardless of whether or not they received study treatment.\n\nThe study was not designed to make formal statistical comparisons of TTP between cohorts.'}, {'type': 'SECONDARY', 'title': 'Progression-Free Survival (PFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '20', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Diffuse Large B-Cell Lymphoma', 'description': 'Patients with relapsed or refractory EBV-positive diffuse large B-cell lymphoma treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD'}, {'id': 'OG001', 'title': 'Extranodal Natural Killer/T-Cell Lymphoma', 'description': 'Patients with relapsed or refractory EBV-positive extranodal natural killer/T-cell lymphoma treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD'}, {'id': 'OG002', 'title': 'Peripheral T-Cell Lymphoma (Combination Therapy)', 'description': 'Patients with relapsed or refractory EBV-positive angioimmunoblastic T-cell lymphoma or peripheral T-cell lymphoma not otherwise specified treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD'}, {'id': 'OG003', 'title': 'Peripheral T-Cell Lymphoma (Monotherapy)', 'description': 'Patients with relapsed or refractory EBV-positive angioimmunoblastic T-cell lymphoma or peripheral T-cell lymphoma not otherwise specified treated with nanatinostat 20 mg QD on Days 1 to 4 per week'}, {'id': 'OG004', 'title': 'Hodgkin Lymphoma', 'description': 'Patients with relapsed or refractory EBV-positive Hodgkin lymphoma treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD'}, {'id': 'OG005', 'title': 'Post-Transplant Lymphoproliferative Disorders', 'description': 'Patients with relapsed or refractory EBV-positive post-transplant lymphoproliferative disorders treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD'}, {'id': 'OG006', 'title': 'Human Immunodeficiency Virus-Associated Lymphomas', 'description': 'Patients with relapsed or refractory EBV-positive human immunodeficiency virus-associated lymphomas treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD'}, {'id': 'OG007', 'title': 'Other EBV-Positive Lymphomas', 'description': 'Patients with relapsed or refractory EBV-positive lymphomas other than those from the other cohorts treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD'}], 'classes': [{'categories': [{'measurements': [{'value': '81', 'groupId': 'OG000', 'lowerLimit': '29', 'upperLimit': '165'}, {'value': '110', 'groupId': 'OG001', 'lowerLimit': '23', 'upperLimit': '517'}, {'value': '124', 'groupId': 'OG002', 'lowerLimit': '14', 'upperLimit': '410'}, {'value': '95', 'groupId': 'OG003', 'lowerLimit': '32', 'upperLimit': '171'}, {'value': '82', 'groupId': 'OG004', 'lowerLimit': '64', 'upperLimit': '313'}, {'value': '79', 'groupId': 'OG005', 'lowerLimit': '36', 'upperLimit': '351'}, {'value': '108', 'groupId': 'OG006', 'lowerLimit': '64', 'upperLimit': '282'}, {'value': '95.5', 'groupId': 'OG007', 'lowerLimit': '35', 'upperLimit': '311'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to approximately 3 years', 'description': 'Interval of time from the start of study drug treatment to the date of first documented disease progression (defined by 2007 IWG criteria as any new lesion or increase by ≥ 50% of previously involved sites from nadir), initiation of new antineoplastic therapy, or death from any cause, whichever occurred first. PFS was censored at the time of study withdrawal for hematopoietic stem cell transplant, at the time of study treatment withdrawal (or at the time of crossover from monotherapy to combination therapy), or at the time of study termination, whichever was earliest, for patients without reported disease progression or death.', 'unitOfMeasure': 'days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat Analysis Set, defined as all patients who were enrolled into the trial regardless of whether or not they received study treatment.\n\nThe study was not designed to make formal statistical comparisons of PFS between cohorts.'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '20', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Diffuse Large B-Cell Lymphoma', 'description': 'Patients with relapsed or refractory EBV-positive diffuse large B-cell lymphoma treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD'}, {'id': 'OG001', 'title': 'Extranodal Natural Killer/T-Cell Lymphoma', 'description': 'Patients with relapsed or refractory EBV-positive extranodal natural killer/T-cell lymphoma treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD'}, {'id': 'OG002', 'title': 'Peripheral T-Cell Lymphoma (Combination Therapy)', 'description': 'Patients with relapsed or refractory EBV-positive angioimmunoblastic T-cell lymphoma or peripheral T-cell lymphoma not otherwise specified treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD'}, {'id': 'OG003', 'title': 'Peripheral T-Cell Lymphoma (Monotherapy)', 'description': 'Patients with relapsed or refractory EBV-positive angioimmunoblastic T-cell lymphoma or peripheral T-cell lymphoma not otherwise specified treated with nanatinostat 20 mg QD on Days 1 to 4 per week'}, {'id': 'OG004', 'title': 'Hodgkin Lymphoma', 'description': 'Patients with relapsed or refractory EBV-positive Hodgkin lymphoma treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD'}, {'id': 'OG005', 'title': 'Post-Transplant Lymphoproliferative Disorders', 'description': 'Patients with relapsed or refractory EBV-positive post-transplant lymphoproliferative disorders treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD'}, {'id': 'OG006', 'title': 'Human Immunodeficiency Virus-Associated Lymphomas', 'description': 'Patients with relapsed or refractory EBV-positive human immunodeficiency virus-associated lymphomas treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD'}, {'id': 'OG007', 'title': 'Other EBV-Positive Lymphomas', 'description': 'Patients with relapsed or refractory EBV-positive lymphomas other than those from the other cohorts treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD'}], 'classes': [{'categories': [{'measurements': [{'value': '131', 'groupId': 'OG000', 'lowerLimit': '29', 'upperLimit': '242'}, {'value': '243', 'groupId': 'OG001', 'lowerLimit': '35', 'upperLimit': '517'}, {'value': '221', 'groupId': 'OG002', 'lowerLimit': '14', 'upperLimit': '730'}, {'value': '155', 'groupId': 'OG003', 'lowerLimit': '41', 'upperLimit': '611'}, {'value': '570.5', 'groupId': 'OG004', 'lowerLimit': '64', 'upperLimit': '1000'}, {'value': '171', 'groupId': 'OG005', 'lowerLimit': '36', 'upperLimit': '351'}, {'value': '108', 'groupId': 'OG006', 'lowerLimit': '76', 'upperLimit': '296'}, {'value': '167.5', 'groupId': 'OG007', 'lowerLimit': '35', 'upperLimit': '513'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to approximately 3 years', 'description': 'Interval of time from the start of study drug treatment to the date of death for any reason. OS was censored at the time of study withdrawal or study termination, whichever was earlier, for patients without reported death.', 'unitOfMeasure': 'days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat Analysis Set, defined as all patients who were enrolled into the trial regardless of whether or not they received study treatment.\n\nThe study was not designed to make formal statistical comparisons of OS between cohorts.'}, {'type': 'SECONDARY', 'title': 'Number (Percentage) of Participants With Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '20', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Diffuse Large B-Cell Lymphoma', 'description': 'Patients with relapsed or refractory EBV-positive diffuse large B-cell lymphoma treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD'}, {'id': 'OG001', 'title': 'Extranodal Natural Killer/T-Cell Lymphoma', 'description': 'Patients with relapsed or refractory EBV-positive extranodal natural killer/T-cell lymphoma treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD'}, {'id': 'OG002', 'title': 'Peripheral T-Cell Lymphoma (Combination Therapy)', 'description': 'Patients with relapsed or refractory EBV-positive angioimmunoblastic T-cell lymphoma or peripheral T-cell lymphoma not otherwise specified treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD'}, {'id': 'OG003', 'title': 'Peripheral T-Cell Lymphoma (Monotherapy)', 'description': 'Patients with relapsed or refractory EBV-positive angioimmunoblastic T-cell lymphoma or peripheral T-cell lymphoma not otherwise specified treated with nanatinostat 20 mg QD on Days 1 to 4 per week'}, {'id': 'OG004', 'title': 'Hodgkin Lymphoma', 'description': 'Patients with relapsed or refractory EBV-positive Hodgkin lymphoma treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD'}, {'id': 'OG005', 'title': 'Post-Transplant Lymphoproliferative Disorders', 'description': 'Patients with relapsed or refractory EBV-positive post-transplant lymphoproliferative disorders treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD'}, {'id': 'OG006', 'title': 'Human Immunodeficiency Virus-Associated Lymphomas', 'description': 'Patients with relapsed or refractory EBV-positive human immunodeficiency virus-associated lymphomas treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD'}, {'id': 'OG007', 'title': 'Other EBV-Positive Lymphomas', 'description': 'Patients with relapsed or refractory EBV-positive lymphomas other than those from the other cohorts treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD'}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '17', 'groupId': 'OG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to approximately 2 years', 'description': 'Number (percentage) of patients experiencing at least one treatment-emergent adverse event, defined as those untoward medical events with onset after the first dose of study drug or existing events that worsened after the first dose during the study', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set, defined as all enrolled patients who received at least 1 dose of study treatment.\n\nThe study was not designed to make formal statistical comparisons of AE numbers (percentages) between cohorts.'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetic (PK) Parameter - Time to Maximum Plasma Concentration [Tmax]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Combination Therapy (EBV-Associated Lymphoid Malignancy)', 'description': 'Patients with relapsed or refractory EBV-positive lymphoma or lymphoproliferative disorder treated with nanatinostat 20 mg once daily (QD) on Days 1 to 4 per week and valganciclovir 900 mg QD'}, {'id': 'OG001', 'title': 'Monotherapy (EBV-Positive Peripheral T-Cell Lymphoma)', 'description': 'Patients with relapsed or refractory EBV-positive angioimmunoblastic T-cell lymphoma or peripheral T-cell lymphoma not otherwise specified treated with nanatinostat 20 mg QD on Days 1 to 4 per week'}], 'classes': [{'title': 'Nanatinostat (Cycle 1 Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '6'}, {'value': '2', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '4'}]}]}, {'title': 'Nanatinostat (Cycle 6 Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '6'}]}]}, {'title': 'M1 Metabolite (Cycle 1 Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '6'}, {'value': '5', 'groupId': 'OG001', 'lowerLimit': '2', 'upperLimit': '6'}]}]}, {'title': 'M1 Metabolite (Cycle 6 Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '6'}]}]}, {'title': 'M2 Metabolite (Cycle 1 Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '6'}, {'value': '2', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '6'}]}]}, {'title': 'M2 Metabolite (Cycle 6 Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '6'}]}]}, {'title': 'Ganciclovir (Cycle 1 Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '6'}]}]}, {'title': 'Ganciclovir (Cycle 6 Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '2'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Cycle 1 Day 1 and Cycle 6 Day 1 at pre-dose and 1, 2, 4, and 6 hours post-dose (each cycle was 28 days)', 'description': 'Defined as the time required to reach peak plasma concentration \\[Cmax\\] after study drug administration', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Defined as all patients (pts) who received at least 1 dose of study drug on Cycle 1 Day 1 and had at least 1 valid PK concentration. Tmax data were previously generated for subset of 50 pts, 4 of whom reached Cycle 6 at time of analysis. As prespecified by the analysis plan, combination therapy cohorts were combined since Tmax for small molecules should not be affected by lymphoma subtype. PK samples from remaining pts were not tested due to sponsor company closure soon after study termination.'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetic (PK) Parameter - Maximum Plasma Concentration [Cmax]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Combination Therapy (EBV-Associated Lymphoid Malignancy)', 'description': 'Patients with relapsed or refractory EBV-positive lymphoma or lymphoproliferative disorder treated with nanatinostat 20 mg once daily (QD) on Days 1 to 4 per week and valganciclovir 900 mg QD'}, {'id': 'OG001', 'title': 'Monotherapy (EBV-Positive Peripheral T-Cell Lymphoma)', 'description': 'Patients with relapsed or refractory EBV-positive angioimmunoblastic T-cell lymphoma or peripheral T-cell lymphoma not otherwise specified treated with nanatinostat 20 mg QD on Days 1 to 4 per week'}], 'classes': [{'title': 'Nanatinostat (Cycle 1 Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '116', 'spread': '68.9', 'groupId': 'OG000'}, {'value': '105', 'spread': '83.0', 'groupId': 'OG001'}]}]}, {'title': 'Nanatinostat (Cycle 6 Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '134', 'spread': '121.3', 'groupId': 'OG000'}]}]}, {'title': 'M1 Metabolite (Cycle 1 Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '435', 'spread': '49.6', 'groupId': 'OG000'}, {'value': '393', 'spread': '48.3', 'groupId': 'OG001'}]}]}, {'title': 'M1 Metabolite (Cycle 6 Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '427', 'spread': '64.6', 'groupId': 'OG000'}]}]}, {'title': 'M2 Metabolite (Cycle 1 Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '75.1', 'spread': '56.5', 'groupId': 'OG000'}, {'value': '65.8', 'spread': '64.3', 'groupId': 'OG001'}]}]}, {'title': 'M2 Metabolite (Cycle 6 Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '82.8', 'spread': '79.0', 'groupId': 'OG000'}]}]}, {'title': 'Ganciclovir (Cycle 1 Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6350', 'spread': '35.7', 'groupId': 'OG000'}]}]}, {'title': 'Ganciclovir (Cycle 6 Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5390', 'spread': '59.6', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 1 Day 1 and Cycle 6 Day 1 at pre-dose and 1, 2, 4, and 6 hours post-dose (each cycle was 28 days)', 'description': 'Defined as the peak plasma concentration \\[Cmax\\] after study drug administration', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Defined as all patients (pts) who received at least 1 dose of study drug on Cycle 1 Day 1 and had at least 1 valid PK concentration. Cmax data were previously generated for subset of 50 pts, 4 of whom reached Cycle 6 at time of analysis. As prespecified by the analysis plan, combination therapy cohorts were combined since Cmax for small molecules should not be affected by lymphoma subtype. PK samples from remaining pts were not tested due to sponsor company closure soon after study termination.'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetic Parameter - Area Under the Plasma Concentration-Time Curve [AUC0-t]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Combination Therapy (EBV-Associated Lymphoid Malignancy)', 'description': 'Patients with relapsed or refractory EBV-positive lymphoma or lymphoproliferative disorder treated with nanatinostat 20 mg once daily (QD) on Days 1 to 4 per week and valganciclovir 900 mg QD'}, {'id': 'OG001', 'title': 'Monotherapy (EBV-Positive Peripheral T-Cell Lymphoma)', 'description': 'Patients with relapsed or refractory EBV-positive angioimmunoblastic T-cell lymphoma or peripheral T-cell lymphoma not otherwise specified treated with nanatinostat 20 mg QD on Days 1 to 4 per week'}], 'classes': [{'title': 'Nanatinostat (Cycle 1 Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '284', 'spread': '46.9', 'groupId': 'OG000'}, {'value': '241', 'spread': '59.3', 'groupId': 'OG001'}]}]}, {'title': 'Nanatinostat (Cycle 6 Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '291', 'spread': '101.2', 'groupId': 'OG000'}]}]}, {'title': 'M1 Metabolite (Cycle 1 Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1470', 'spread': '70.6', 'groupId': 'OG000'}, {'value': '1410', 'spread': '56.8', 'groupId': 'OG001'}]}]}, {'title': 'M1 Metabolite (Cycle 6 Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3750', 'spread': '42.2', 'groupId': 'OG000'}]}]}, {'title': 'M2 Metabolite (Cycle 1 Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '263', 'spread': '71.9', 'groupId': 'OG000'}, {'value': '248', 'spread': '66.2', 'groupId': 'OG001'}]}]}, {'title': 'M2 Metabolite (Cycle 6 Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '335', 'spread': '168.2', 'groupId': 'OG000'}]}]}, {'title': 'Ganciclovir (Cycle 1 Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '21600', 'spread': '34.9', 'groupId': 'OG000'}]}]}, {'title': 'Ganciclovir (Cycle 6 Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '33400', 'spread': '20.4', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 1 Day 1 and Cycle 6 Day 1 at pre-dose and 1, 2, 4, and 6 hours post-dose (each cycle was 28 days)', 'description': 'Defined as the area under the concentration-time curve from time 0 to the last measurable plasma concentration', 'unitOfMeasure': 'ng*h/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Defined as all patients (pts) who received at least 1 dose of study drug on Cycle 1 Day 1 and had at least 1 valid PK concentration. AUC0-t data were previously generated for subset of 50 pts, 4 of whom reached Cycle 6 at time of analysis. As prespecified by the analysis plan, combination therapy cohorts were combined since AUC for small molecules should not be affected by lymphoma subtype. PK samples from remaining pts were not tested due to sponsor company closure soon after study termination.'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetic (PK) Parameter - Half-Life [t1/2]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Combination Therapy (EBV-Associated Lymphoid Malignancy)', 'description': 'Patients with relapsed or refractory EBV-positive lymphoma or lymphoproliferative disorder treated with nanatinostat 20 mg once daily (QD) on Days 1 to 4 per week and valganciclovir 900 mg QD'}, {'id': 'OG001', 'title': 'Monotherapy (EBV-Positive Peripheral T-Cell Lymphoma)', 'description': 'Patients with relapsed or refractory EBV-positive angioimmunoblastic T-cell lymphoma or peripheral T-cell lymphoma not otherwise specified treated with nanatinostat 20 mg QD on Days 1 to 4 per week'}], 'classes': [{'title': 'Nanatinostat (Cycle 1 Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.52', 'spread': '0.464', 'groupId': 'OG000'}, {'value': '2.17', 'spread': '0.503', 'groupId': 'OG001'}]}]}, {'title': 'Nanatinostat (Cycle 6 Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.21', 'spread': '0', 'groupId': 'OG000'}]}]}, {'title': 'Ganciclovir (Cycle 1 Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.41', 'spread': '1.34', 'groupId': 'OG000'}]}]}, {'title': 'Ganciclovir (Cycle 6 Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.31', 'spread': '2.36', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Cycle 1 Day 1 and Cycle 6 Day 1 at pre-dose and 1, 2, 4, and 6 hours post-dose (each cycle was 28 days)', 'description': 'Defined as the time required to reduce plasma concentration by 50% after study drug administration', 'unitOfMeasure': 'hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Defined as all patients who received at least 1 dose of study drug on Cycle 1 Day 1 and had at least 2 valid PK concentrations in the terminal elimination phase. This stricter requirement explains why, for example, the overall number analyzed for t1/2 (ie, 16) is less than the overall number analyzed for the other PK parameters (ie, 50). As prespecified by the analysis plan, combination therapy cohorts were combined since t1/2 for small molecules should not be affected by lymphoma subtype.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Objective Response Rate (ORR) by Study Milestone in the Peripheral T-Cell Lymphoma (Combination Therapy) Cohort That Enrolled Patients Beyond Stage 1 or in the Peripheral T-Cell Lymphoma (Monotherapy) Cohort Who Crossed Over to Receive Combination Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 1 (Peripheral T-Cell Lymphoma)', 'description': 'Patients with relapsed or refractory EBV-positive angioimmunoblastic T-cell lymphoma or peripheral T-cell lymphoma not otherwise specified treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD in the first stage of the study'}, {'id': 'OG001', 'title': 'Stage 1 (Peripheral T-Cell Lymphoma - Second Line)', 'description': 'Patients with second-line relapsed or refractory EBV-positive angioimmunoblastic T-cell lymphoma or peripheral T-cell lymphoma not otherwise specified treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD in the first stage of the study'}, {'id': 'OG002', 'title': 'Stage 2 (Peripheral T-Cell Lymphoma)', 'description': 'Patients with relapsed or refractory EBV-positive angioimmunoblastic T-cell lymphoma or peripheral T-cell lymphoma not otherwise specified treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD in the second stage of the study'}, {'id': 'OG003', 'title': 'Stage 2 (Peripheral T-Cell Lymphoma - Second Line)', 'description': 'Patients with second-line relapsed or refractory EBV-positive angioimmunoblastic T-cell lymphoma or peripheral T-cell lymphoma not otherwise specified treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD in the second stage of the study'}, {'id': 'OG004', 'title': 'Expansion (Peripheral T-Cell Lymphoma)', 'description': 'Patients with relapsed or refractory EBV-positive angioimmunoblastic T-cell lymphoma or peripheral T-cell lymphoma not otherwise specified treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD in the expansion stage of the study'}, {'id': 'OG005', 'title': 'Expansion (Peripheral T-Cell Lymphoma - Second Line)', 'description': 'Patients with second-line relapsed or refractory EBV-positive angioimmunoblastic T-cell lymphoma or peripheral T-cell lymphoma not otherwise specified treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD in the expansion stage of the study'}, {'id': 'OG006', 'title': 'Crossover (Peripheral T-Cell Lymphoma)', 'description': 'Patients with relapsed or refractory EBV-positive angioimmunoblastic T-cell lymphoma or peripheral T-cell lymphoma not otherwise specified treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD after having been treated with nanatinostat 20 mg QD on Days 1 to 4 per week without response in the monotherapy cohort'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to approximately 2 years', 'description': 'Number (percentage) of patients with a best overall complete response (CR) or partial response (PR) according to the 2007 International Working Group (IWG) criteria, where CR included complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy with all lymph nodes and nodal masses having regressed on computed tomography to normal size, and PR included at least a 50% decrease in sum of the product of the diameters (SPD) of up to six of the largest dominant nodes or nodal masses, no increase should have been observed in the size of other nodes, liver, or spleen, and splenic and hepatic nodules must have regressed by ≥ 50% in their SPD or, for single nodules, in the greatest transverse diameter.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat Analysis Set, defined as all patients who were enrolled into the trial regardless of whether or not they received study treatment.\n\nThe sum of the Overall Number of Participants Analyzed across all subgroups (ie, 57) additionally includes pre-specified ORR analyses in a subset of 14 patients in the Peripheral T-Cell Lymphoma (Combination Therapy) cohort previously treated with only 1 line of anti-lymphoma therapy.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Duration of Response (DOR) by Study Milestone in the Peripheral T-Cell Lymphoma (Combination Therapy) Cohort That Enrolled Patients Beyond Stage 1 or in the Peripheral T-Cell Lymphoma (Monotherapy) Cohort Who Crossed Over to Receive Combination Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 1 (Peripheral T-Cell Lymphoma)', 'description': 'Patients with relapsed or refractory EBV-positive angioimmunoblastic T-cell lymphoma or peripheral T-cell lymphoma not otherwise specified treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD in the first stage of the study'}, {'id': 'OG001', 'title': 'Stage 1 (Peripheral T-Cell Lymphoma - Second Line)', 'description': 'Patients with second-line relapsed or refractory EBV-positive angioimmunoblastic T-cell lymphoma or peripheral T-cell lymphoma not otherwise specified treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD in the first stage of the study'}, {'id': 'OG002', 'title': 'Stage 2 (Peripheral T-Cell Lymphoma)', 'description': 'Patients with relapsed or refractory EBV-positive angioimmunoblastic T-cell lymphoma or peripheral T-cell lymphoma not otherwise specified treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD in the second stage of the study'}, {'id': 'OG003', 'title': 'Stage 2 (Peripheral T-Cell Lymphoma - Second Line)', 'description': 'Patients with second-line relapsed or refractory EBV-positive angioimmunoblastic T-cell lymphoma or peripheral T-cell lymphoma not otherwise specified treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD in the second stage of the study'}, {'id': 'OG004', 'title': 'Expansion (Peripheral T-Cell Lymphoma)', 'description': 'Patients with relapsed or refractory EBV-positive angioimmunoblastic T-cell lymphoma or peripheral T-cell lymphoma not otherwise specified treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD in the expansion stage of the study'}, {'id': 'OG005', 'title': 'Expansion (Peripheral T-Cell Lymphoma - Second Line)', 'description': 'Patients with second-line relapsed or refractory EBV-positive angioimmunoblastic T-cell lymphoma or peripheral T-cell lymphoma not otherwise specified treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD in the expansion stage of the study'}, {'id': 'OG006', 'title': 'Peripheral T-Cell Lymphoma (Crossover)', 'description': 'Patients with relapsed or refractory EBV-positive angioimmunoblastic T-cell lymphoma or peripheral T-cell lymphoma not otherwise specified treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD after having been treated with nanatinostat 20 mg QD on Days 1 to 4 per week without response in the monotherapy cohort'}], 'classes': [{'categories': [{'measurements': [{'value': '86', 'groupId': 'OG000', 'lowerLimit': '36', 'upperLimit': '340'}, {'value': '86', 'groupId': 'OG001', 'lowerLimit': '36', 'upperLimit': '340'}, {'value': '125', 'groupId': 'OG002', 'lowerLimit': '29', 'upperLimit': '221'}, {'value': '29', 'groupId': 'OG003', 'lowerLimit': '29', 'upperLimit': '29'}, {'value': '99', 'groupId': 'OG004', 'lowerLimit': '73', 'upperLimit': '126'}, {'value': '73', 'groupId': 'OG005', 'lowerLimit': '73', 'upperLimit': '73'}, {'value': '192', 'groupId': 'OG006', 'lowerLimit': '79', 'upperLimit': '305'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to approximately 2 years', 'description': 'Interval of time from date of first observed complete or partial response per 2007 International Working Group (IWG) criteria to the date of documented disease progression or death due to any cause, where disease progression is defined by 2007 IWG criteria as any new lesion or increase by ≥ 50% of previously involved sites from nadir. DOR was censored at the time of study withdrawal for hematopoietic stem cell transplant, or at the time of study termination, whichever was earlier, for patients whose disease was still in response.', 'unitOfMeasure': 'days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients who achieved a CR or PR'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Diffuse Large B-Cell Lymphoma', 'description': 'Patients with relapsed or refractory EBV-positive diffuse large B-cell lymphoma treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD'}, {'id': 'FG001', 'title': 'Extranodal Natural Killer/T-Cell Lymphoma', 'description': 'Patients with relapsed or refractory EBV-positive extranodal natural killer/T-cell lymphoma treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD'}, {'id': 'FG002', 'title': 'Peripheral T-Cell Lymphoma (Combination Therapy)', 'description': 'Patients with relapsed or refractory EBV-positive angioimmunoblastic T-cell lymphoma or peripheral T-cell lymphoma not otherwise specified treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD'}, {'id': 'FG003', 'title': 'Peripheral T-Cell Lymphoma (Monotherapy)', 'description': 'Patients with relapsed or refractory EBV-positive angioimmunoblastic T-cell lymphoma or peripheral T-cell lymphoma not otherwise specified treated with nanatinostat 20 mg QD on Days 1 to 4 per week'}, {'id': 'FG004', 'title': 'Hodgkin Lymphoma', 'description': 'Patients with relapsed or refractory EBV-positive Hodgkin lymphoma treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD'}, {'id': 'FG005', 'title': 'Post-Transplant Lymphoproliferative Disorders', 'description': 'Patients with relapsed or refractory EBV-positive post-transplant lymphoproliferative disorders treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD'}, {'id': 'FG006', 'title': 'Human Immunodeficiency Virus-Associated Lymphomas', 'description': 'Patients with relapsed or refractory EBV-positive human immunodeficiency virus-associated lymphomas treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD'}, {'id': 'FG007', 'title': 'Other EBV-Positive Lymphomas', 'description': 'Patients with relapsed or refractory EBV-positive lymphomas other than those from the other cohorts treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '38'}, {'groupId': 'FG003', 'numSubjects': '10'}, {'groupId': 'FG004', 'numSubjects': '8'}, {'groupId': 'FG005', 'numSubjects': '3'}, {'groupId': 'FG006', 'numSubjects': '3'}, {'groupId': 'FG007', 'numSubjects': '20'}]}, {'type': 'Stage 1', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'comment': 'More than 10 patients were enrolled in Stage 1 of the Extranodal Natural Killer/T-Cell Lymphoma cohort because the tenth and eleventh patients had signed informed consent concurrently.', 'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '10'}, {'groupId': 'FG003', 'numSubjects': '10'}, {'groupId': 'FG004', 'numSubjects': '8'}, {'groupId': 'FG005', 'numSubjects': '3'}, {'groupId': 'FG006', 'numSubjects': '3'}, {'comment': 'No more than 10 patients of a given lymphoma subtype were enrolled in Stage 1 of the Other EBV-Positive Lymphomas cohort.', 'groupId': 'FG007', 'numSubjects': '20'}]}, {'type': 'Stage 2', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '11'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Expansion', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '17'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Crossover', 'comment': 'Crossover only applies to patients enrolled in the Peripheral T-Cell Lymphoma (Monotherapy) cohort who were subsequently provided the option to cross over to receive combination therapy.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '24'}, {'groupId': 'FG003', 'numSubjects': '10'}, {'groupId': 'FG004', 'numSubjects': '8'}, {'groupId': 'FG005', 'numSubjects': '2'}, {'groupId': 'FG006', 'numSubjects': '3'}, {'groupId': 'FG007', 'numSubjects': '15'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '14'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Sponsor Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '14'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '5'}]}]}], 'recruitmentDetails': 'Patients with Epstein-Barr virus (EBV)-associated lymphoid malignancy were nonrandomly assigned to one of 7 cohorts defined in the Study Description module, except the first 20 patients with peripheral T-cell lymphoma were randomized (1:1) to receive either combination nanatinostat plus valganciclovir therapy or nanatinostat monotherapy.\n\nUp to 10 (Stage 1), up to 11 (Stage 2), and up to 120 (Expansion) patients were to be enrolled in each cohort depending on the number of responses observed.', 'preAssignmentDetails': 'Patients enrolled in the Peripheral T-Cell Lymphoma (Monotherapy) cohort who had stable disease at 6 weeks or disease progression at any time (confirmed by CT or MRI) were provided the option to cross over to receive combination therapy for the remainder of the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}, {'value': '20', 'groupId': 'BG007'}, {'value': '102', 'groupId': 'BG008'}]}], 'groups': [{'id': 'BG000', 'title': 'Diffuse Large B-Cell Lymphoma', 'description': 'Patients with relapsed or refractory EBV-positive diffuse large B-cell lymphoma treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD'}, {'id': 'BG001', 'title': 'Extranodal Natural Killer/T-Cell Lymphoma', 'description': 'Patients with relapsed or refractory EBV-positive extranodal natural killer/T-cell lymphoma treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD'}, {'id': 'BG002', 'title': 'Peripheral T-Cell Lymphoma (Combination Therapy)', 'description': 'Patients with relapsed or refractory EBV-positive angioimmunoblastic T-cell lymphoma or peripheral T-cell lymphoma not otherwise specified treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD'}, {'id': 'BG003', 'title': 'Peripheral T-Cell Lymphoma (Monotherapy)', 'description': 'Patients with relapsed or refractory EBV-positive angioimmunoblastic T-cell lymphoma or peripheral T-cell lymphoma not otherwise specified treated with nanatinostat 20 mg QD on Days 1 to 4 per week'}, {'id': 'BG004', 'title': 'Hodgkin Lymphoma', 'description': 'Patients with relapsed or refractory EBV-positive Hodgkin lymphoma treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD'}, {'id': 'BG005', 'title': 'Post-Transplant Lymphoproliferative Disorders', 'description': 'Patients with relapsed or refractory EBV-positive post-transplant lymphoproliferative disorders treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD'}, {'id': 'BG006', 'title': 'Human Immunodeficiency Virus-Associated Lymphomas', 'description': 'Patients with relapsed or refractory EBV-positive human immunodeficiency virus-associated lymphomas treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD'}, {'id': 'BG007', 'title': 'Other EBV-Positive Lymphomas', 'description': 'Patients with relapsed or refractory EBV-positive lymphomas other than those from the other cohorts treated with nanatinostat 20 mg QD on Days 1 to 4 per week and valganciclovir 900 mg QD'}, {'id': 'BG008', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}, {'value': '9', 'groupId': 'BG007'}, {'value': '53', 'groupId': 'BG008'}]}, {'title': '>=65 years', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '11', 'groupId': 'BG007'}, {'value': '49', 'groupId': 'BG008'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '60', 'groupId': 'BG000', 'lowerLimit': '21', 'upperLimit': '82'}, {'value': '53', 'groupId': 'BG001', 'lowerLimit': '32', 'upperLimit': '71'}, {'value': '69', 'groupId': 'BG002', 'lowerLimit': '47', 'upperLimit': '85'}, {'value': '69', 'groupId': 'BG003', 'lowerLimit': '53', 'upperLimit': '78'}, {'value': '53.5', 'groupId': 'BG004', 'lowerLimit': '23', 'upperLimit': '69'}, {'value': '50', 'groupId': 'BG005', 'lowerLimit': '48', 'upperLimit': '67'}, {'value': '47', 'groupId': 'BG006', 'lowerLimit': '46', 'upperLimit': '57'}, {'value': '64', 'groupId': 'BG007', 'lowerLimit': '39', 'upperLimit': '86'}, {'value': '64', 'groupId': 'BG008', 'lowerLimit': '21', 'upperLimit': '86'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '6', 'groupId': 'BG007'}, {'value': '37', 'groupId': 'BG008'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}, {'value': '14', 'groupId': 'BG007'}, {'value': '65', 'groupId': 'BG008'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '2', 'groupId': 'BG007'}, {'value': '15', 'groupId': 'BG008'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}, {'value': '18', 'groupId': 'BG007'}, {'value': '83', 'groupId': 'BG008'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '4', 'groupId': 'BG008'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '1', 'groupId': 'BG008'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '7', 'groupId': 'BG007'}, {'value': '24', 'groupId': 'BG008'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 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'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '1', 'groupId': 'BG008'}]}]}, {'title': 'France', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '6', 'groupId': 'BG008'}]}]}, {'title': 'Germany', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '1', 'groupId': 'BG008'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-10-26', 'size': 1625130, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-02-21T19:40', 'hasProtocol': True}, {'date': '2024-10-09', 'size': 744114, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-02-21T19:41', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'This is an open-label, single-arm study utilizing a basket trial design.\n\nThe study was terminated prematurely and did not reach its target enrollment.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 102}}, 'statusModule': {'whyStopped': 'Sponsor Decision', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2021-05-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-08', 'studyFirstSubmitDate': '2021-08-02', 'resultsFirstSubmitDate': '2025-03-28', 'studyFirstSubmitQcDate': '2021-08-11', 'lastUpdatePostDateStruct': {'date': '2025-07-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-07-08', 'studyFirstPostDateStruct': {'date': '2021-08-18', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-07-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Objective Response Rate (ORR) by Study Milestone in the Peripheral T-Cell Lymphoma (Combination Therapy) Cohort That Enrolled Patients Beyond Stage 1 or in the Peripheral T-Cell Lymphoma (Monotherapy) Cohort Who Crossed Over to Receive Combination Therapy', 'timeFrame': 'Up to approximately 2 years', 'description': 'Number (percentage) of patients with a best overall complete response (CR) or partial response (PR) according to the 2007 International Working Group (IWG) criteria, where CR included complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy with all lymph nodes and nodal masses having regressed on computed tomography to normal size, and PR included at least a 50% decrease in sum of the product of the diameters (SPD) of up to six of the largest dominant nodes or nodal masses, no increase should have been observed in the size of other nodes, liver, or spleen, and splenic and hepatic nodules must have regressed by ≥ 50% in their SPD or, for single nodules, in the greatest transverse diameter.'}, {'measure': 'Duration of Response (DOR) by Study Milestone in the Peripheral T-Cell Lymphoma (Combination Therapy) Cohort That Enrolled Patients Beyond Stage 1 or in the Peripheral T-Cell Lymphoma (Monotherapy) Cohort Who Crossed Over to Receive Combination Therapy', 'timeFrame': 'Up to approximately 2 years', 'description': 'Interval of time from date of first observed complete or partial response per 2007 International Working Group (IWG) criteria to the date of documented disease progression or death due to any cause, where disease progression is defined by 2007 IWG criteria as any new lesion or increase by ≥ 50% of previously involved sites from nadir. DOR was censored at the time of study withdrawal for hematopoietic stem cell transplant, or at the time of study termination, whichever was earlier, for patients whose disease was still in response.'}], 'primaryOutcomes': [{'measure': 'Objective Response Rate (ORR)', 'timeFrame': 'Up to approximately 2 years', 'description': 'Number (percentage) of patients with a best overall complete response (CR) or partial response (PR) according to the 2007 International Working Group (IWG) criteria, where CR included complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy with all lymph nodes and nodal masses having regressed on computed tomography to normal size, and PR included at least a 50% decrease in sum of the product of the diameters (SPD) of up to six of the largest dominant nodes or nodal masses, no increase should have been observed in the size of other nodes, liver, or spleen, and splenic and hepatic nodules must have regressed by ≥ 50% in their SPD or, for single nodules, in the greatest transverse diameter.'}], 'secondaryOutcomes': [{'measure': 'Duration of Response (DOR)', 'timeFrame': 'Up to approximately 2 years', 'description': 'Interval of time from date of first observed complete or partial response per 2007 International Working Group (IWG) criteria to the date of documented disease progression or death due to any cause, where disease progression is defined by 2007 IWG criteria as any new lesion or increase by ≥ 50% of previously involved sites from nadir. DOR was censored at the time of study withdrawal for hematopoietic stem cell transplant, or at the time of study termination, whichever was earlier, for patients whose disease was still in response.'}, {'measure': 'Time to Next Anti-Lymphoma Treatment (TTNLT)', 'timeFrame': 'Up to approximately 3 years', 'description': 'Interval of time from the start of study drug treatment to the date of next anti-lymphoma treatment (including chemotherapy, radiotherapy, radioimmunotherapy, or immunotherapy).'}, {'measure': 'Time to Progression (TTP)', 'timeFrame': 'Up to approximately 3 years', 'description': 'Interval of time from the start of study drug treatment to the date of disease progression, where disease progression is defined by 2007 IWG criteria as any new lesion or increase by ≥ 50% of previously involved sites from nadir. TTP was censored at the time of study withdrawal for hematopoietic stem cell transplant, at the time of study treatment withdrawal (or at the time of crossover from monotherapy to combination therapy), or at the time of study termination, whichever was earliest, for patients without reported disease progression.'}, {'measure': 'Progression-Free Survival (PFS)', 'timeFrame': 'Up to approximately 3 years', 'description': 'Interval of time from the start of study drug treatment to the date of first documented disease progression (defined by 2007 IWG criteria as any new lesion or increase by ≥ 50% of previously involved sites from nadir), initiation of new antineoplastic therapy, or death from any cause, whichever occurred first. PFS was censored at the time of study withdrawal for hematopoietic stem cell transplant, at the time of study treatment withdrawal (or at the time of crossover from monotherapy to combination therapy), or at the time of study termination, whichever was earliest, for patients without reported disease progression or death.'}, {'measure': 'Overall Survival (OS)', 'timeFrame': 'Up to approximately 3 years', 'description': 'Interval of time from the start of study drug treatment to the date of death for any reason. OS was censored at the time of study withdrawal or study termination, whichever was earlier, for patients without reported death.'}, {'measure': 'Number (Percentage) of Participants With Adverse Events (AEs)', 'timeFrame': 'Up to approximately 2 years', 'description': 'Number (percentage) of patients experiencing at least one treatment-emergent adverse event, defined as those untoward medical events with onset after the first dose of study drug or existing events that worsened after the first dose during the study'}, {'measure': 'Pharmacokinetic (PK) Parameter - Time to Maximum Plasma Concentration [Tmax]', 'timeFrame': 'Cycle 1 Day 1 and Cycle 6 Day 1 at pre-dose and 1, 2, 4, and 6 hours post-dose (each cycle was 28 days)', 'description': 'Defined as the time required to reach peak plasma concentration \\[Cmax\\] after study drug administration'}, {'measure': 'Pharmacokinetic (PK) Parameter - Maximum Plasma Concentration [Cmax]', 'timeFrame': 'Cycle 1 Day 1 and Cycle 6 Day 1 at pre-dose and 1, 2, 4, and 6 hours post-dose (each cycle was 28 days)', 'description': 'Defined as the peak plasma concentration \\[Cmax\\] after study drug administration'}, {'measure': 'Pharmacokinetic Parameter - Area Under the Plasma Concentration-Time Curve [AUC0-t]', 'timeFrame': 'Cycle 1 Day 1 and Cycle 6 Day 1 at pre-dose and 1, 2, 4, and 6 hours post-dose (each cycle was 28 days)', 'description': 'Defined as the area under the concentration-time curve from time 0 to the last measurable plasma concentration'}, {'measure': 'Pharmacokinetic (PK) Parameter - Half-Life [t1/2]', 'timeFrame': 'Cycle 1 Day 1 and Cycle 6 Day 1 at pre-dose and 1, 2, 4, and 6 hours post-dose (each cycle was 28 days)', 'description': 'Defined as the time required to reduce plasma concentration by 50% after study drug administration'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Epstein-Barr virus (EBV)', 'EBV-positive lymphomas', 'EBV-positive T-cell lymphoma', 'EBV-positive Hodgkin lymphoma', 'EBV-positive diffuse large B-cell lymphoma (DLBCL)', 'EBV-positive extranodal natural killer/T-cell lymphoma', 'EBV-positive peripheral T-cell lymphoma (PTCL)', 'EBV-positive post-transplant lymphoproliferative disorders'], 'conditions': ['Epstein-Barr Virus Associated Lymphoma', 'EBV-Positive DLBCL, NOS', 'EBV-Related Non-Hodgkin Lymphoma', 'EBV Related PTCL, NOS', 'EBV-Related Hodgkin Lymphoma', 'EBV-Related PTLD', 'EBV-Related Lymphoproliferative Disorder']}, 'referencesModule': {'references': [{'pmid': '17242396', 'type': 'BACKGROUND', 'citation': 'Cheson BD, Pfistner B, Juweid ME, Gascoyne RD, Specht L, Horning SJ, Coiffier B, Fisher RI, Hagenbeek A, Zucca E, Rosen ST, Stroobants S, Lister TA, Hoppe RT, Dreyling M, Tobinai K, Vose JM, Connors JM, Federico M, Diehl V; International Harmonization Project on Lymphoma. Revised response criteria for malignant lymphoma. J Clin Oncol. 2007 Feb 10;25(5):579-86. doi: 10.1200/JCO.2006.09.2403. Epub 2007 Jan 22.'}, {'pmid': '37530631', 'type': 'DERIVED', 'citation': 'Haverkos B, Alpdogan O, Baiocchi R, Brammer JE, Feldman TA, Capra M, Brem EA, Nair S, Scheinberg P, Pereira J, Shune L, Joffe E, Young P, Spruill S, Katkov A, McRae R, Royston I, Faller DV, Rojkjaer L, Porcu P. Targeted therapy with nanatinostat and valganciclovir in recurrent EBV-positive lymphoid malignancies: a phase 1b/2 study. Blood Adv. 2023 Oct 24;7(20):6339-6350. doi: 10.1182/bloodadvances.2023010330.'}]}, 'descriptionModule': {'briefSummary': 'A Phase 2 study to evaluate the efficacy of nanatinostat in combination with valganciclovir in patients with relapsed/refractory EBV-positive lymphomas', 'detailedDescription': "Patients with EBV-associated lymphomas have inferior outcomes with standard-of-care therapies compared to those with EBV-negative disease. Nanatinostat is a selective class I HDAC inhibitor which induces EBV lytic phase protein generation, activating (val)ganciclovir to its cytotoxic form. This open-label, multicenter, multinational, single-arm, Phase 2 basket study employs a Simon's 2-stage design to allow termination of enrollment into cohorts where treatment appears futile, and will include the following cohorts of patients with EBV+ relapsed/refractory lymphomas:\n\n1. Diffuse large B-cell lymphoma (DLBCL)\n2. Extranodal natural killer/T-cell lymphoma (ENKTL)\n3. Peripheral T-cell lymphoma (PTCL), including angioimmunoblastic T-cell lymphoma (AITL) and PTCL not otherwise specified (PTCL-NOS)\n4. Hodgkin lymphoma (HL)\n5. Post-transplant lymphoproliferative disorders (PTLD)\n6. Human immunodeficiency virus (HIV)-associated lymphomas (HIV-L)\n7. EBV+ lymphomas other than the above\n\nThe study was terminated prematurely and did not reach its target enrollment."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* EBV+ DLBCL, NOS and PTCL, NOS, and AITL: Relapsed/refractory disease following 1 or more prior systemic therapy(ies) with curative intent.\n* For EBV+ PTLD patients: Relapsed/refractory disease following 1 prior therapy and must have received at least 1 course of an anti-CD20 immunotherapy. For patients with EBV+ PTLD only, age 12 years and older and weighing greater than 40 kg (Adolescent, Adult, Older Adult) are allowed\n* For other EBV+ relapsed/refractory lymphoma: Following at least 1 course of an anit-CD20 immunotherapy and at least 1 course of anthracycline-based chemotherapy (unless contraindicated)\n* No available therapies in the opinion of the Investigator\n* Not eligible for high-dose chemotherapy with allogeneic/autologous stem cell transplantation or CAR-T therapy\n* Measurable disease per Cheson 2007\n* ECOG performance status 0, 1, 2\n* Adequate bone marrow function\n\nKey Exclusion Criteria:\n\n* Presence or history of CNS involvement by lymphoma\n* Systemic anticancer therapy or CAR-T within 21 days\n* Antibody (anticancer) agents within 28 days\n* Less than 60 days from prior autologous hematopoietic stem cell or solid organ transplant\n* Less than 90 days from prior allogeneic transplant.\n* Daily corticosteroids (≥20 mg of prednisone or equivalent) within week prior to Cycle 1 Day 1\n* Inability to take oral medication, malabsorption syndrome or any other gastrointestinal condition (nausea, diarrhea, vomiting) that may impact the absorption of nanatinostat and valganciclovir.\n* Active infection requiring systemic therapy (excluding viral upper respiratory tract infections).'}, 'identificationModule': {'nctId': 'NCT05011058', 'acronym': 'NAVAL-1', 'briefTitle': 'An Open-Label Phase 2 Trial of Nanatinostat Plus Valganciclovir in Patients With EBV+ Relapsed/Refractory Lymphomas', 'organization': {'class': 'INDUSTRY', 'fullName': 'Viracta Therapeutics, Inc.'}, 'officialTitle': 'An Open-Label, Phase 2 Trial of Nanatinostat in Combination With Valganciclovir in Patients With Epstein-Barr Virus-Positive (EBV+) Relapsed/Refractory Lymphomas', 'orgStudyIdInfo': {'id': 'VT3996-202'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nanatinostat with Valganciclovir', 'description': 'Patients will receive nanatinostat 20 mg orally once daily, days 1-4 per week with valganciclovir 900 mg orally once daily.\n\nUp to 10 PTCL patients will receive nanatinostat 20 mg orally once daily, days 1-4 per week.', 'interventionNames': ['Drug: Nanatinostat in combination with valganciclovir']}], 'interventions': [{'name': 'Nanatinostat in combination with valganciclovir', 'type': 'DRUG', 'otherNames': ['VRx-3996 in combination with Valcyte'], 'description': 'Drug: Nanatinostat, 20 mg orally once daily, 4 days per week in 28 day cycles\n\nDrug: Valganciclovir, 900 mg orally once daily in 28 day cycles', 'armGroupLabels': ['Nanatinostat with Valganciclovir']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'The University of Alabama at Birmingham Comprehensive Cancer Center', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '91010', 'city': 'Duarte', 'state': 'California', 'country': 'United States', 'facility': 'City of Hope', 'geoPoint': {'lat': 34.13945, 'lon': -117.97729}}, {'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'David Geffen School of Medicine - 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