RECRUITING

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

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Conditions

Peripheral T Cell LymphomaRelapsed Peripheral T-Cell LymphomaPeripheral T-Cell Lymphoma, Not Otherwise SpecifiedAnaplastic Large Cell LymphomaMycosis FungoidesRelapsed Anaplastic Large Cell LymphomaRelapsed Mycosis Fungoides

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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 ipilimumab and 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.

Official Title

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/Dendritic Cell Neoplasms

Quick Facts

Study Start:2024-01-05
Study Completion:2032-04-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06508463

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age \>= 18 years
  2. * Relapsed or refractory:
  3. * 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)
  4. * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =\< 2 times upper limit of normal (ULN) (obtained =\< 15 days prior to registration)
  5. * Creatinine =\< 2.0 mg/dL (obtained =\< 15 days prior to registration)
  6. * Direct bilirubin =\< 1.5 x ULN (obtained =\< 15 days prior to registration)
  7. * International normalized ratio (INR)/prothrombin time (PT) and activated partial thromboplastin time (aPTT) =\< 1.5 x ULN (obtained =\< 15 days prior to registration)
  8. * If baseline liver disease, Child Pugh score not exceeding class A (obtained =\< 15 days prior to registration)
  9. * Negative pregnancy test for persons of child-bearing potential (obtained =\< 15 days prior to registration)
  10. * FOR T-Cell Lymphoma (TCL)/B-Cell Lymphoma (BCL) ONLY: Absolute Neutrophil Count (ANC) \>= 1,000/microliter (μL) (obtained =\< 14 days prior to registration)
  11. * FOR TCL/BCL ONLY: Platelets \>= 100,000/μL (obtained =\< 14 days prior to registration)
  12. * FOR TCL/BCL ONLY: Hemoglobin \>= 8.5 g/dl (obtained =\< 14 days prior to registration)
  13. * 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
  14. * Absence of active central nervous system (CNS) involvement; NOTE: pre-enrollment lumbar puncture not mandatory
  15. * Ability to provide written informed consent
  16. * Willingness to return to Mayo Clinic for follow-up
  17. * Life expectancy \>= 12 weeks
  18. * Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, or 2
  19. * Willing to provide mandatory biological specimens for research purposes
  1. * Availability of and patient acceptance of curative therapy
  2. * Uncontrolled infection
  3. * Active tuberculosis or hepatitis, or chronic hepatitis
  4. * Any of the following prior therapies:
  5. * Chemotherapy (IMIDs, alkylating agents, proteosome inhibitors) =\< 2 weeks prior to registration
  6. * Immunotherapy (monoclonal antibodies) =\< 4 weeks prior to registration
  7. * Experimental agent in case of Acute Myeloid Leukemia (AML) or TCL within 4 half-lives of the last dose of the agent
  8. * 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 \[atrial fibrillation or supraventricular tachycardia (SVT)\]
  9. * 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)
  10. * Human immunodeficiency virus (HIV) positive test result or other immunodeficiency or immunosuppression
  11. * 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);
  12. * 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)
  13. * 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:
  14. * Pregnant women or women of reproductive ability who are unwilling to use effective contraception
  15. * Nursing women
  16. * 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
  17. * ADDITIONAL EXCLUSION CRITERIA FOR GROUP E (COMBINATION WITH IPILIMUMAB AND CEMIPLIMAB) ONLY:
  18. * Diagnosis of AML
  19. * Diagnosis of Angioimmunoblastic T-cell Lymphoma (AITL)
  20. * Hypersensitivity to ipilimumab or its excipients

Contacts and Locations

Study Contact

Clinical Trials Referral Office
CONTACT
855-776-0015
mayocliniccancerstudies@mayo.edu

Principal Investigator

Kah Whye Peng, PhD
PRINCIPAL_INVESTIGATOR
Mayo Clinic in Rochester
Nora Bennani, MD
PRINCIPAL_INVESTIGATOR
Mayo Clinic in Rochester

Study Locations (Sites)

Mayo Clinic in Arizona
Scottsdale, Arizona, 85259
United States
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
United States

Collaborators and Investigators

Sponsor: Mayo Clinic

  • Kah Whye Peng, PhD, PRINCIPAL_INVESTIGATOR, Mayo Clinic in Rochester
  • Nora Bennani, MD, PRINCIPAL_INVESTIGATOR, Mayo Clinic in Rochester

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-01-05
Study Completion Date2032-04-01

Study Record Updates

Study Start Date2024-01-05
Study Completion Date2032-04-01

Terms related to this study

Additional Relevant MeSH Terms

  • 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