Intravenous Vesicular Stomatitis Virus in Patients With Peripheral T-cell Lymphoma
NCT ID: NCT06508463
Last Updated: 2025-10-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
21 participants
INTERVENTIONAL
2024-01-05
2032-04-01
Brief Summary
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Detailed Description
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Patients 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.
After 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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Group E (VSV-IFNβ-NIS, ipilimumab, cemiplimab) - Peripheral T-cell lymphoma (PTCL) only
PTCL patients receive VSV-IFNβ-NIS IV over 30 minutes on day 1, ipilimumab IV over 30 minutes on day -3 and cemiplimab IV over 30 minutes on day -3 in the absence of disease progression or unacceptable toxicity. Patients undergo SPECT, CT scan, PET scan throughout the study. Patients may undergo tumor biopsy, bone marrow biopsy and blood sample collection throughout the study.
Biopsy
Undergo tumor biopsy
Biospecimen Collection
Undergo blood sample collection
Bone Marrow Biopsy
Undergo bone marrow biopsy
Computed Tomography
Undergo SPECT/CT
Positron Emission Tomography
Undergo PET scan
Recombinant Vesicular Stomatitis Virus-expressing Human Interferon Beta and Sodium-Iodide Symporter
Given IV
Single Photon Emission Computed Tomography
Undergo SPECT/CT
Cemiplimab
Given IV
Ipilimumab
Given IV
Group E (VSV-IFNβ-NIS, ipilimumab, cemiplimab) - PTCL Expansion Cohort
PTCL patients receive VSV-IFNβ-NIS IV over 30 minutes on day 1, ipilimumab IV over 30 minutes on day -3 and cemiplimab IV over 30 minutes on day -3 in the absence of disease progression or unacceptable toxicity. Patients undergo SPECT, CT scan, PET scan throughout the study. Patients may undergo tumor biopsy, bone marrow biopsy and blood sample collection throughout the study.
Biopsy
Undergo tumor biopsy
Biospecimen Collection
Undergo blood sample collection
Bone Marrow Biopsy
Undergo bone marrow biopsy
Computed Tomography
Undergo SPECT/CT
Positron Emission Tomography
Undergo PET scan
Recombinant Vesicular Stomatitis Virus-expressing Human Interferon Beta and Sodium-Iodide Symporter
Given IV
Single Photon Emission Computed Tomography
Undergo SPECT/CT
Cemiplimab
Given IV
Ipilimumab
Given IV
Interventions
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Biopsy
Undergo tumor biopsy
Biospecimen Collection
Undergo blood sample collection
Bone Marrow Biopsy
Undergo bone marrow biopsy
Computed Tomography
Undergo SPECT/CT
Positron Emission Tomography
Undergo PET scan
Recombinant Vesicular Stomatitis Virus-expressing Human Interferon Beta and Sodium-Iodide Symporter
Given IV
Single Photon Emission Computed Tomography
Undergo SPECT/CT
Cemiplimab
Given IV
Ipilimumab
Given IV
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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) =\< 2 times upper limit of normal (ULN) (obtained =\< 15 days prior to registration)
* Creatinine =\< 2.0 mg/dL (obtained =\< 15 days prior to registration)
* Direct bilirubin =\< 1.5 x ULN (obtained =\< 15 days prior to registration)
* International normalized ratio (INR)/prothrombin time (PT) and activated partial thromboplastin time (aPTT) =\< 1.5 x ULN (obtained =\< 15 days prior to registration)
* If baseline liver disease, Child Pugh score not exceeding class A (obtained =\< 15 days prior to registration)
* Negative pregnancy test for persons of child-bearing potential (obtained =\< 15 days prior to registration)
* FOR T-Cell Lymphoma (TCL)/B-Cell Lymphoma (BCL) ONLY: Absolute Neutrophil Count (ANC) \>= 1,000/microliter (μL) (obtained =\< 14 days prior to registration)
* FOR TCL/BCL ONLY: Platelets \>= 100,000/μL (obtained =\< 14 days prior to registration)
* FOR TCL/BCL ONLY: Hemoglobin \>= 8.5 g/dl (obtained =\< 14 days prior to registration)
* FOR TCL/BCL 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/L; 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
Exclusion Criteria
* Uncontrolled infection
* Active tuberculosis or hepatitis, or chronic hepatitis
* Any of the following prior therapies:
* Chemotherapy (IMIDs, alkylating agents, proteosome inhibitors) =\< 2 weeks prior to registration
* Immunotherapy (monoclonal antibodies) =\< 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 pruritis 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)
* Hypersensitivity to ipilimumab or its excipients
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Mayo Clinic
OTHER
Responsible Party
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Principal Investigators
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Kah Whye Peng, PhD
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic in Rochester
Nora Bennani, MD
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic in Rochester
Locations
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Mayo Clinic in Arizona
Scottsdale, Arizona, United States
Mayo Clinic in Rochester
Rochester, Minnesota, United States
Countries
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Central Contacts
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Facility Contacts
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References
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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/bloodadvances.2021006631.
Related Links
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Mayo Clinic Clinical Trials
Other Identifiers
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NCI-2017-00049
Identifier Type: REGISTRY
Identifier Source: secondary_id
MC1684
Identifier Type: OTHER
Identifier Source: secondary_id
16-005474
Identifier Type: OTHER
Identifier Source: secondary_id
MC1684 Arm E
Identifier Type: -
Identifier Source: org_study_id
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