[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06508463":3,"trial-entities:NCT06508463":252,"trial-summary:NCT06508463":255},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":26,"study_type":27,"primary_purpose":28,"phases":29,"enrollment_info":31,"interventions":34,"primary_outcomes":140,"secondary_outcomes":145,"sex":155,"minimum_age":156,"maximum_age":157,"healthy_volunteers":158,"eligibility_criteria":159,"std_ages":200,"locations":203,"central_contacts":236,"overall_officials":238,"references":243,"see_also_links":248},"NCT06508463","MC1684 Arm E","Intravenous Vesicular Stomatitis Virus in Patients With Peripheral T-cell Lymphoma","MC1684 Phase I Trial of Systemic Administration of Vesicular Stomatitis Virus Genetically Engineered to Express NIS and Human Interferon, in Patients With Relapsed or Refractory Multiple Myeloma, Acute Myeloid Leukemia, Lymphomas, or Histiocytic\u002FDendritic Cell Neoplasms","RECRUITING","2032-04-01","2026-06","2026-07-01","2024-01-05","Mayo Clinic","OTHER",true,"This phase I trial studies the best dose and side effects of recombinant vesicular stomatitis virus (VSV) carrying the human (h) sodium iodide symporter (NIS) and Interferon (IFN) beta (β) genes (VSV-hIFNβ-NIS) in combination with cemiplimab in patients with T-cell lymphoma. A virus, called VSV-hIFNβ-NIS, which has been changed in a certain way, may be able to kill cancer cells without damaging normal cells. Immunotherapy with ipilmumab and cemiplimab may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread.","PRIMARY OBJECTIVE: To determine the maximum tolerated dose (MTD) of VSV-hIFNβ-NIS in combination with cemiplimab in patients with T-cell lymphoma \\[Group E\\].\n\nPatients undergo computed tomography (CT) scan, position emission tomography (PET) scan throughout the study. Patients may undergo tumor biopsy, bone marrow biopsy and blood sample collection throughout the study.\n\nAfter completion of study treatment, patients are followed up for 28 days, and then every 3 months for up to 1 year or until progressive disease, then every 6 months for 1 year.",[19,20,21,22,23,24,25],"Peripheral T Cell Lymphoma","Relapsed Peripheral T-Cell Lymphoma","Peripheral T-Cell Lymphoma, Not Otherwise Specified","Anaplastic Large Cell Lymphoma","Mycosis Fungoides","Relapsed Anaplastic Large Cell Lymphoma","Relapsed Mycosis Fungoides",[],"INTERVENTIONAL","TREATMENT",[30],"PHASE1",{"count":32,"type":33},21,"ESTIMATED",[35,45,53,60,74,87,101,116,128],{"type":36,"name":37,"description":38,"armGroupLabels":39,"otherNames":42},"PROCEDURE","Biopsy","Undergo tumor biopsy",[40,41],"Group E (VSV-IFNβ-NIS, cemiplimab, ruxolitinib) - PTCL Expansion Cohort","Group E (VSV-IFNβ-NIS, cemiplimab, ruxolitinib) - Peripheral T-cell lymphoma (PTCL) only",[43,44],"BIOPSY_TYPE","Bx",{"type":36,"name":46,"description":47,"armGroupLabels":48,"otherNames":49},"Biospecimen Collection","Undergo blood sample collection",[40,41],[50,51,52],"Biological Sample Collection","Biospecimen Collected","Specimen Collection",{"type":36,"name":54,"description":55,"armGroupLabels":56,"otherNames":57},"Bone Marrow Biopsy","Undergo bone marrow biopsy",[40,41],[58,59],"Biopsy of Bone Marrow","Biopsy, Bone Marrow",{"type":36,"name":61,"description":62,"armGroupLabels":63,"otherNames":64},"Computed Tomography","Undergo SPECT\u002FCT",[40,41],[65,66,67,68,69,70,71,72,73],"CAT","CAT Scan","Computed Axial Tomography","Computerized Axial Tomography","Computerized axial tomography (procedure)","Computerized Tomography","CT","CT Scan","tomography",{"type":36,"name":75,"description":76,"armGroupLabels":77,"otherNames":78},"Positron Emission Tomography","Undergo PET scan",[40,41],[79,80,81,82,83,84,85,86],"Medical Imaging, Positron Emission Tomography","PET","PET Scan","Positron emission tomography (procedure)","Positron Emission Tomography Scan","Positron-Emission Tomography","proton magnetic resonance spectroscopic imaging","PT",{"type":88,"name":89,"description":90,"armGroupLabels":91,"otherNames":92},"BIOLOGICAL","Recombinant Vesicular Stomatitis Virus-expressing Human Interferon Beta and Sodium-Iodide Symporter","Given IV",[40,41],[93,94,95,96,97,98,99,100],"Oncolytic VSV-hIFNbeta-NIS","Vesicular Stomatitis Virus-expressing Human Interferon Beta and Sodium-Iodide Symporter","Voyager-V1","VSV-expressing hIFNb and NIS","VSV-hIFNb-NIS","VSV-hIFNbeta-NIS","VV1","VSV-hIFNβ-NIS",{"type":36,"name":102,"description":62,"armGroupLabels":103,"otherNames":104},"Single Photon Emission Computed Tomography",[40,41],[105,106,107,108,109,110,111,112,113,114,115],"Medical Imaging, Single Photon Emission Computed Tomography","Single Photon Emission Tomography","Single-Photon Emission Computed","single-photon emission computed tomography","SPECT","SPECT imaging","SPECT SCAN","SPET","ST","tomography, emission computed, single photon","Tomography, Emission-Computed, Single-Photon",{"type":88,"name":117,"description":90,"armGroupLabels":118,"otherNames":119},"Cemiplimab",[40,41],[120,121,122,123,124,125,126,127],"1801342-60-8","Cemiplimab RWLC","Cemiplimab-rwlc","Immunoglobulin G4","Anti-(Human Programmed Cell Death Protein 1) (Human Monoclonal REGN2810 Heavy Chain)","Disulfide with Human Monoclonal REGN2810 kappa-chain","Libtayo","REGN2810",{"type":129,"name":130,"description":131,"armGroupLabels":132,"otherNames":133},"DRUG","Ruxolitinib","Given PO",[40,41],[134,135,136,137,138,139],"941678-49-5","INCB 018424","INCB-018424","INCB-18424","INCB18424","Oral JAK Inhibitor INCB18424",[141],{"measure":142,"description":143,"timeFrame":144},"Incidence of adverse events of grade 3 or higher","Assessed according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.","Up to 2 years",[146,149,152],{"measure":147,"description":148,"timeFrame":144},"Clinical response","Response to treatment will be recorded as stringent Complete Response (sCR), complete response (CR), very good partial response (VGPR), partial response (PR), Minimal Response (MR), stable disease (SD), and progressive disease (PD).",{"measure":150,"description":151,"timeFrame":144},"Progression-free survival (PFS)","PFS is defined as the time from study enrollment to disease progression or death due to any cause.",{"measure":153,"description":154,"timeFrame":144},"Overall survival (OS)","OS is defined as the time from study enrollment to death due to any cause.","ALL","18 Years",null,false,{"inclusion":160,"exclusion":180,"raw_text":199},[161,162,163,164,165,166,167,168,169,170,171,172,173,174,175,176,177,178,179],"Age \\>= 18 years","Relapsed or refractory:","Group E only: Relapsed peripheral T-cell lymphoma (PTCL) of the following histologies: peripheral T-cell lymphoma-NOS (PTCL-NOS); anaplastic large cell (ALCL), and mycosis fungoides (MF)","Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =\\\u003C 2 times upper limit of normal (ULN) (obtained =\\\u003C 15 days prior to registration)","Creatinine =\\\u003C 2.0 mg\u002FdL (obtained =\\\u003C 15 days prior to registration)","Direct bilirubin =\\\u003C 1.5 x ULN (obtained =\\\u003C 15 days prior to registration)","International normalized ratio (INR)\u002Fprothrombin time (PT) and activated partial thromboplastin time (aPTT) =\\\u003C 1.5 x ULN (obtained =\\\u003C 15 days prior to registration)","If baseline liver disease, Child Pugh score not exceeding class A (obtained =\\\u003C 15 days prior to registration)","Negative pregnancy test for persons of child-bearing potential (obtained =\\\u003C 15 days prior to registration)","FOR T-Cell Lymphoma (TCL)\u002FB-Cell Lymphoma (BCL) ONLY: Absolute Neutrophil Count (ANC) \\>= 1,000\u002Fmicroliter (μL) (obtained =\\\u003C 14 days prior to registration)","FOR TCL\u002FBCL ONLY: Platelets \\>= 100,000\u002FμL (obtained =\\\u003C 14 days prior to registration)","FOR TCL\u002FBCL ONLY: Hemoglobin \\>= 8.5 g\u002Fdl (obtained =\\\u003C 14 days prior to registration)","FOR TCL\u002FBCL ONLY: Measurable disease by CT or magnetic resonance imaging (MRI): must have at least one lesion that has a single diameter of \\> 2 cm or tumor cells in the blood \\> 5 x 10\\^9\u002FL; NOTE: skin lesions can be used if the area is \\> 2 cm in at least one diameter and photographed with a ruler and the images are available in the medical record","Absence of active central nervous system (CNS) involvement; NOTE: pre-enrollment lumbar puncture not mandatory","Ability to provide written informed consent","Willingness to return to Mayo Clinic for follow-up","Life expectancy \\>= 12 weeks","Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, or 2","Willing to provide mandatory biological specimens for research purposes",[181,182,183,184,185,186,187,188,189,190,191,192,193,194,195,196,197,198],"Availability of and patient acceptance of curative therapy","Uncontrolled infection","Active tuberculosis or hepatitis, or chronic hepatitis","Any of the following prior therapies:","Chemotherapy (IMIDs, alkylating agents, proteosome inhibitors) =\\\u003C 2 weeks prior to registration","Immunotherapy (monoclonal antibodies) =\\\u003C 4 weeks prior to registration","Experimental agent in case of Acute Myeloid Leukemia (AML) or TCL within 4 half-lives of the last dose of the agent","New York Heart Association classification III or IV, known symptomatic coronary artery disease, or symptoms of coronary artery disease on systems review, or known cardiac arrhythmias \\[atrial fibrillation or supraventricular tachycardia (SVT)\\]","Active CNS disorder or seizure disorder or known CNS disease or neurologic symptomatology; in case of AML active CNS involvement as detected by lumbar puncture or neuro-imaging (only to be done if clinically indicated)","Human immunodeficiency virus (HIV) positive test result or other immunodeficiency or immunosuppression","Other concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy considered investigational (used for a non-Food and Drug Administration \\[FDA\\] approved indication and in the context of a research investigation);","NOTE: in TCL, patients may use topical emollients or corticosteroids, acetic acid soaks, etc. to control pruritus and prevent infection; no topical chemotherapy is allowed (no topical nitrogen mustard)","Any of the following because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown:","Pregnant women or women of reproductive ability who are unwilling to use effective contraception","Nursing women","Men who are unwilling to use a condom (even if they have undergone a prior vasectomy) while having intercourse with any woman, while taking the drug and for 4 weeks after stopping treatment","Diagnosis of AML","Diagnosis of Angioimmunoblastic T-cell Lymphoma (AITL)","Inclusion Criteria:\n\n* Age \\>= 18 years\n* Relapsed or refractory:\n\n  * Group E only: Relapsed peripheral T-cell lymphoma (PTCL) of the following histologies: peripheral T-cell lymphoma-NOS (PTCL-NOS); anaplastic large cell (ALCL), and mycosis fungoides (MF)\n* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =\\\u003C 2 times upper limit of normal (ULN) (obtained =\\\u003C 15 days prior to registration)\n* Creatinine =\\\u003C 2.0 mg\u002FdL (obtained =\\\u003C 15 days prior to registration)\n* Direct bilirubin =\\\u003C 1.5 x ULN (obtained =\\\u003C 15 days prior to registration)\n* International normalized ratio (INR)\u002Fprothrombin time (PT) and activated partial thromboplastin time (aPTT) =\\\u003C 1.5 x ULN (obtained =\\\u003C 15 days prior to registration)\n* If baseline liver disease, Child Pugh score not exceeding class A (obtained =\\\u003C 15 days prior to registration)\n* Negative pregnancy test for persons of child-bearing potential (obtained =\\\u003C 15 days prior to registration)\n* FOR T-Cell Lymphoma (TCL)\u002FB-Cell Lymphoma (BCL) ONLY: Absolute Neutrophil Count (ANC) \\>= 1,000\u002Fmicroliter (μL) (obtained =\\\u003C 14 days prior to registration)\n* FOR TCL\u002FBCL ONLY: Platelets \\>= 100,000\u002FμL (obtained =\\\u003C 14 days prior to registration)\n* FOR TCL\u002FBCL ONLY: Hemoglobin \\>= 8.5 g\u002Fdl (obtained =\\\u003C 14 days prior to registration)\n* FOR TCL\u002FBCL ONLY: Measurable disease by CT or magnetic resonance imaging (MRI): must have at least one lesion that has a single diameter of \\> 2 cm or tumor cells in the blood \\> 5 x 10\\^9\u002FL; NOTE: skin lesions can be used if the area is \\> 2 cm in at least one diameter and photographed with a ruler and the images are available in the medical record\n* Absence of active central nervous system (CNS) involvement; NOTE: pre-enrollment lumbar puncture not mandatory\n* Ability to provide written informed consent\n* Willingness to return to Mayo Clinic for follow-up\n* Life expectancy \\>= 12 weeks\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, or 2\n* Willing to provide mandatory biological specimens for research purposes\n\nExclusion Criteria:\n\n* Availability of and patient acceptance of curative therapy\n* Uncontrolled infection\n* Active tuberculosis or hepatitis, or chronic hepatitis\n* Any of the following prior therapies:\n\n  * Chemotherapy (IMIDs, alkylating agents, proteosome inhibitors) =\\\u003C 2 weeks prior to registration\n  * Immunotherapy (monoclonal antibodies) =\\\u003C 4 weeks prior to registration\n  * Experimental agent in case of Acute Myeloid Leukemia (AML) or TCL within 4 half-lives of the last dose of the agent\n* New York Heart Association classification III or IV, known symptomatic coronary artery disease, or symptoms of coronary artery disease on systems review, or known cardiac arrhythmias \\[atrial fibrillation or supraventricular tachycardia (SVT)\\]\n* Active CNS disorder or seizure disorder or known CNS disease or neurologic symptomatology; in case of AML active CNS involvement as detected by lumbar puncture or neuro-imaging (only to be done if clinically indicated)\n* Human immunodeficiency virus (HIV) positive test result or other immunodeficiency or immunosuppression\n* Other concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy considered investigational (used for a non-Food and Drug Administration \\[FDA\\] approved indication and in the context of a research investigation);\n\n  * NOTE: in TCL, patients may use topical emollients or corticosteroids, acetic acid soaks, etc. to control pruritus and prevent infection; no topical chemotherapy is allowed (no topical nitrogen mustard)\n* Any of the following because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown:\n\n  * Pregnant women or women of reproductive ability who are unwilling to use effective contraception\n  * Nursing women\n  * Men who are unwilling to use a condom (even if they have undergone a prior vasectomy) while having intercourse with any woman, while taking the drug and for 4 weeks after stopping treatment\n* ADDITIONAL EXCLUSION CRITERIA FOR GROUP E (COMBINATION WITH CEMIPLIMAB) ONLY:\n\n  * Diagnosis of AML\n  * Diagnosis of Angioimmunoblastic T-cell Lymphoma (AITL)",[201,202],"ADULT","OLDER_ADULT",[204,222],{"facility":205,"status":8,"city":206,"state":207,"zip":208,"country":209,"contacts":210,"geoPoint":219},"Mayo Clinic in Arizona","Scottsdale","Arizona","85259","United States",[211,216],{"name":212,"role":213,"phone":214,"email":215},"Clinical Trials Referral Office","CONTACT","855-776-0015","mayocliniccancerstudies@mayo.edu",{"name":217,"role":218},"Nathan Punwani, M.D.","PRINCIPAL_INVESTIGATOR",{"lat":220,"lon":221},33.50921,-111.89903,{"facility":223,"status":8,"city":224,"state":225,"zip":226,"country":209,"contacts":227,"geoPoint":233},"Mayo Clinic in Rochester","Rochester","Minnesota","55905",[228,229,231],{"name":212,"role":213,"phone":214,"email":215},{"name":230,"role":218},"Kah Whye Peng, Ph.D.",{"name":232,"role":218},"Nora Bennani, M.D.",{"lat":234,"lon":235},44.02163,-92.4699,[237],{"name":212,"role":213,"phone":214,"email":215},[239,241],{"name":240,"affiliation":223,"role":218},"Kah Whye Peng, PhD",{"name":242,"affiliation":223,"role":218},"Nora Bennani, MD",[244],{"pmid":245,"type":246,"citation":247},"35175355","RESULT","Cook J, Peng KW, Witzig TE, Broski SM, Villasboas JC, Paludo J, Patnaik M, Rajkumar V, Dispenzieri A, Leung N, Buadi F, Bennani N, Ansell SM, Zhang L, Packiriswamy N, Balakrishnan B, Brunton B, Giers M, Ginos B, Dueck AC, Geyer S, Gertz MA, Warsame R, Go RS, Hayman SR, Dingli D, Kumar S, Bergsagel L, Munoz JL, Gonsalves W, Kourelis T, Muchtar E, Kapoor P, Kyle RA, Lin Y, Siddiqui M, Fonder A, Hobbs M, Hwa L, Naik S, Russell SJ, Lacy MQ. Clinical activity of single-dose systemic oncolytic VSV virotherapy in patients with relapsed refractory T-cell lymphoma. Blood Adv. 2022 Jun 14;6(11):3268-3279. doi: 10.1182\u002Fbloodadvances.2021006631.",[249],{"label":250,"url":251},"Mayo Clinic Clinical Trials","https:\u002F\u002Fwww.mayo.edu\u002Fresearch\u002Fclinical-trials",{"nct_id":4,"conditions":253,"biomarkers":254},[22,23,21],[],{"nct_id":4,"found":15,"summary":256,"prompt_version":266},{"design":257,"status":258,"heading":259,"summary":260,"follow_up":261,"word_count":262,"commitments":263,"compensation":264,"drugs_mentioned":265},"This is a Phase 1 interventional study aiming to enroll 21 participants. It is designed to find the maximum tolerated dose of the treatments.","completed","Study of VSV-hIFNβ-NIS and Cemiplimab for T-cell Lymphoma","This study is testing a new approach for people with relapsed or difficult-to-treat peripheral T-cell lymphoma (PTCL), including specific types like PTCL-NOS, anaplastic large cell lymphoma (ALCL), and mycosis fungoides (MF). It's looking at the safety and best dose of a modified virus called VSV-hIFNβ-NIS, which is designed to target cancer cells, when given with cemiplimab. Cemiplimab is an immunotherapy that works by changing your body's immune system to fight cancer. The study aims to see how well these treatments work together and what side effects might occur. You may be able to join if you are 18 or older and have relapsed or refractory PTCL, with specific liver function test results.","After treatment, you would be followed for 28 days, then every 3 months for up to 1 year or until your disease progresses, and then every 6 months for another year.",112,"You would undergo procedures like CT scans, PET scans, and potentially tumor biopsies, bone marrow biopsies, and blood sample collections throughout the study.","Not stated in the trial record.",[],"v2"]