Health TrialsbyHealthPanel

Intravenous Vesicular Stomatitis Virus in Patients With Peripheral T-cell Lymphoma

ConditionsPeripheral T Cell LymphomaRelapsed Peripheral T-Cell LymphomaPeripheral T-Cell Lymphoma, Not Otherwise SpecifiedAnaplastic Large Cell LymphomaMycosis FungoidesRelapsed Anaplastic Large Cell LymphomaRelapsed Mycosis Fungoides
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorMayo Clinic

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age >= 18 years

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)

Disqualifiers

Availability of and patient acceptance of curative therapy

Uncontrolled infection

Active tuberculosis or hepatitis, or chronic hepatitis

Chemotherapy (IMIDs, alkylating agents, proteosome inhibitors) =< 2 weeks prior to registration

Trial design

Design model

Parallel

Treatments tested in this trial

  • Biopsy

    Procedure/Surgery

    Undergo tumor biopsy

  • Biospecimen Collection

    Procedure/Surgery

    Undergo blood sample collection

  • Bone Marrow Biopsy

    Procedure/Surgery

    Undergo bone marrow biopsy

  • Computed Tomography

    Procedure/Surgery

    Undergo SPECT/CT

  • Positron Emission Tomography

    Procedure/Surgery

    Undergo PET scan

  • Recombinant Vesicular Stomatitis Virus-expressing Human Interferon Beta and Sodium-Iodide Symporter

    Biological/Vaccine

    Given IV

  • Single Photon Emission Computed Tomography

    Procedure/Surgery

    Undergo SPECT/CT

  • Cemiplimab

    Biological/Vaccine

    Given IV

  • Ruxolitinib

    Drug

    Given PO

Treatment groups

21 Participants
are divided into 2 treatment groups
Group A: Group E (VSV-IFNβ-NIS, cemiplimab, ruxolitinib) - Peripheral T-cell lymphoma (PTCL) onlyExperimental treatment 9 interventions
Group B: Group E (VSV-IFNβ-NIS, cemiplimab, ruxolitinib) - PTCL Expansion CohortExperimental treatment 9 interventions

Trial outcomes

Primary outcomes

1

Incidence of adverse events of grade 3 or higher

Assessed according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.

Time frame
Up to 2 years

Secondary outcomes

1

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).

Time frame
Up to 2 years
2

Progression-free survival (PFS)

PFS is defined as the time from study enrollment to disease progression or death due to any cause.

Time frame
Up to 2 years
3

Overall survival (OS)

OS is defined as the time from study enrollment to death due to any cause.

Time frame
Up to 2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mayo Clinic

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov
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