IA Trial Radar | ||
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O estudo clínico NCT06508463 para Linfoma de células T periféricas, Linfoma de células T periféricas recidivado, Linfoma de Células T Periféricas, Não Especificado de Outra Forma, Linfoma Anaplásico de Grandes Células, Micose fungoide, Relapsed Anaplastic Large Cell Lymphoma, Relapsed Mycosis Fungoides está recrutando. Consulte a visualização em cartões do Radar de Estudos Clínicos e as ferramentas de descoberta de IA para ver todos os detalhes. Ou pergunte qualquer coisa aqui. | ||
Clínica MaioIntravenous Vesicular Stomatitis Virus in Patients With Peripheral T-cell Lymphoma
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.
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
- MC1684 Arm E
- R01CA262613 (Subvenção/Contrato NIH (EUA))
- P50CA186781 (Subvenção/Contrato NIH (EUA))
- NCI-2017-00049 (Identificador de registro) (CTRP (Clinical Trial Reporting Program))
- MC1684 (Outro identificador) (Mayo Clinic)
- 16-005474 (Outro identificador) (Mayo Clinic Institutional Review Board)
| Grupo de participantes/Braço | Intervenção/Tratamento |
|---|---|
ExperimentalGroup 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. | Biópsia Undergo tumor biopsy Coleta de biospecimen Undergo blood sample collection Biópsia da medula óssea Undergo bone marrow biopsy Tomografia computadorizada Undergo SPECT/CT Tomografia por emissão de pósitrons Undergo PET scan Recombinant Vesicular Stomatitis Virus-expressing Human Interferon Beta and Sodium-iodide Symporter Given IV Tomografia computadorizada por emissão de fóton único Undergo SPECT/CT Cemiplimab Given IV Ipilimumab Given IV |
ExperimentalGroup 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. | Biópsia Undergo tumor biopsy Coleta de biospecimen Undergo blood sample collection Biópsia da medula óssea Undergo bone marrow biopsy Tomografia computadorizada Undergo SPECT/CT Tomografia por emissão de pósitrons Undergo PET scan Recombinant Vesicular Stomatitis Virus-expressing Human Interferon Beta and Sodium-iodide Symporter Given IV Tomografia computadorizada por emissão de fóton único Undergo SPECT/CT Cemiplimab Given IV Ipilimumab Given IV |
| Medida de desfecho | Descrição da medida | Prazo |
|---|---|---|
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 |
| Medida de desfecho | Descrição da medida | Prazo |
|---|---|---|
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). | Up to 2 years |
Progression-free survival (PFS) | PFS is defined as the time from study enrollment to disease progression or death due to any cause. | Up to 2 years |
Overall survival (OS) | OS is defined as the time from study enrollment to death due to any cause. | Up to 2 years |
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
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
Clínica Maio868 estudos clínicos ativos para explorarInstituto Nacional do Câncer, EUA3028 estudos clínicos ativos para explorarArizona
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