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

Launched by MAYO CLINIC · Jul 12, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment approach for patients with certain types of T-cell lymphoma, such as peripheral T-cell lymphoma and anaplastic large cell lymphoma. The treatment involves a specially modified virus that may help kill cancer cells while sparing normal cells, combined with two immunotherapy drugs, ipilimumab and cemiplimab. These drugs work by boosting the body's immune system to better fight the cancer. The trial aims to find the best dose of the virus and understand its side effects.

To participate in this trial, patients must be at least 18 years old and have relapsed or hard-to-treat T-cell lymphoma. Some key health requirements include having stable liver and kidney function and a life expectancy of at least 12 weeks. Participants will receive treatment and have regular follow-ups at the Mayo Clinic to monitor their response and any side effects. It's important to note that women who are pregnant or breastfeeding, as well as those with certain health conditions, may not be eligible for this study.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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) =\< 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:
• • 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) =\< 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
• * ADDITIONAL EXCLUSION CRITERIA FOR GROUP E (COMBINATION WITH IPILIMUMAB AND CEMIPLIMAB) ONLY:
• • Diagnosis of AML
• • Diagnosis of Angioimmunoblastic T-cell Lymphoma (AITL)
• • Hypersensitivity to ipilimumab or its excipients