Identification of the Best Treatment Pathway for Patients With Relapsed/Refractory Lymphocytic B-derived Non-Hodgkin Lymphoma (ASCLEPIO)
Identification of the Best Treatment Pathway for Patients With Relapsed/Refractory Lymphocytic B-derived Non-Hodgkin Lymphoma, Through the Identification of Prognostic Factors and Mechanisms of Resistance to Bispecific Antibody Therapy
Descripción general del estudio
Estado
Condiciones
Descripción detallada
This exploratory study aims to obtain a first identification of clinical and biological characteristics related to response and toxicity to bispecific antibodies.
Having this information, currently not available in the scientific literature and to be validated in further studies, therapies with BsAbs can be addressed only to patients for whom they have proven useful, improving the results of the therapy pharmacological (more responses and less toxicity) and consequently the sustainability and efficiency of the healthcare system.
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Beatrice Casadei, MD
- Número de teléfono: +39 051 2143480
- Correo electrónico: beatrice.casadei10@unibo.it
Ubicaciones de estudio
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Emilia-Romagna
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Bologna, Emilia-Romagna, Italia, 40138
- IRCCS Policlinico di Sant'Orsola
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Contacto:
- Beatrice Casadei, MD
- Número de teléfono: +39 051 2143480
- Correo electrónico: beatrice.casadei10@unibo.it
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
This is a single-center, observational pharmacological, non-profit study with a tissue component and collection of biological samples, which involves a prospective enrollment of patients treated with BsAbs who will be followed for a period of at least 18 months. All patients will be treated according to clinical practice and will follow the clinical care pathway required by the standard operating procedures of the IRCCS AOUBO Hospital Authority.
The search for biomarkers predictive of response and toxicity, as well as the description of potential resistance mechanisms to BsAbs treatment, will be conducted by a multidisciplinary team involving several Operational Units (UOs) of the IRCCS AOUBO.
In particular, the units involved in the specific study analyses will be the Nuclear Medicine Operational Unit, Hemolymphopathology, Gastroenterology and Digestive Endoscopy, Internal Medicine and Digestive Pathophysiology and the Biology and Molecular Medicine Platform, Intestinal Microbiomics.
Descripción
Inclusion Criteria:
- Age≥18 years
- Patients with histologically documented non-Hodgkin B lymphoma, with relapsed/refractory disease and candidates for BsAbs therapy (glofitamab, epcoritamab, mosunetuzumab) according to clinical indication and AIFA reimbursement criteria
- obtaining signed and dated informed consent before the start of any screening or study-specific procedure
Exclusion Criteria:
- Evidence of concomitant and uncontrolled diseases that could affect protocol compliance or interpretation of results.
- Concomitant secondary neoplasm.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Identify potential predictors of toxicity to BsAbs therapy in patients with relapsed/refractory non-Hodgkin B lymphoma
Periodo de tiempo: During the entire duration of treatment and up to 12 months after the last administration
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Therapy toxicity defined as the occurrence of at least one of the following conditions:
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During the entire duration of treatment and up to 12 months after the last administration
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Identify potential predictors of response to BsAbs therapy in patients with relapsed/refractory non-Hodgkin B lymphoma
Periodo de tiempo: At the end of treatment, approximately 1 month after last cycle treatment (up to 12 months from baseline). Indiviadual cycle lengths range from 21 to 28 days depending on the specific drug regimen, with a maximum treatment duration of 12 months.
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Response to therapy defined as the occurrence of any of the following conditions:
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At the end of treatment, approximately 1 month after last cycle treatment (up to 12 months from baseline). Indiviadual cycle lengths range from 21 to 28 days depending on the specific drug regimen, with a maximum treatment duration of 12 months.
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Identify and describe potential mechanisms of resistance (ongoing metabolic progression or at the end of BsAbs treatment/metabolic relapse) to BsAbs treatment
Periodo de tiempo: Through study completion, up to 12 months
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Presence (yes/no) of resistance to the treatment, identified by PET (Deauville Score) in patients undergoing at least 1 course of treatment, in case of SD >3, through:
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Through study completion, up to 12 months
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- ASCLEPIO
- RC-2025-2794601 (Otro número de subvención/financiamiento: Ministry of health)
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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