Bromuro de sepantronio para el tratamiento del linfoma de células B de alto grado
Un estudio de fase 2, multicéntrico, abierto, de rango de dosis de bromuro de sepantronio en pacientes con linfoma de células B de alto grado con reordenamiento de c-Myc recidivante/refractario (HGBCL)
This is a multi-center Phase 2 study to determine the safety and efficacy of sepantronium bromide (SepB) in adult patients with relapsed or refractory high-grade B-cell lymphoma
Descripción general del estudio
Estado
Condiciones
- Linfoma de células B
- Linfoma de células B grandes, difuso
- Enfermedades linfáticas
- Linfoma de Burkitt
- Linfoma de células B de alto grado
- C-MYC/BCL6 Linfoma de células B de alto grado de doble impacto
- C-MYC/BCL2 Linfoma de células B de alto grado de doble impacto
- Linfoma de alto grado
- Reordenamiento del gen C-Myc
Intervención / Tratamiento
Descripción detallada
This is a multi-center, open label, dose-ranging Phase 2 study evaluating the safety and efficacy of SepB in patients with relapsed/refractory c-Myc rearranged HGBCL.
Cohorts of three patients will be enrolled at each dose level for SepB with expansion to six patients, if necessary, to assess toxicity.
Following the completion of 2 cycles of treatment of each cohort, an independent Data Monitoring Committee (DMC) will review the safety data to assess study drug related toxicities from the current cohort. Following this review, a decision will be made to continue dose escalation to the next dose level, to declare that a given dose level is the level of dose-limiting toxicity (DLT) or to further explore toxicity at the dose level in question by enrolling additional subjects to a maximum of six subjects at that level.
An additional 6 patients will be enrolled at the recommended Phase 2 dose (RP2D). The RP2D will be established on the basis of the maximally tolerated dose between the two specified dose levels as well as other relevant data, including clinical signals of activity, pharmacokinetic (PK) and pharmacodynamic (PD) data.
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 2
Contactos y Ubicaciones
Ubicaciones de estudio
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Busan, Corea del Sur
- Dong-A University Hospital
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Busan, Corea del Sur
- Inje University Haeundae Paik hospital
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Seoul, Corea del Sur
- Samsung Medical Center
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Seoul, Corea del Sur
- Seoul National University Hospital
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Seoul, Corea del Sur
- Seoul St.Mary's Hospital
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Beijing, Porcelana
- Beijing Cancer Hospital
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Guangzhou, Porcelana
- Sun Yat-sen University Cancer Center
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Henan, Porcelana
- Henan Cancer Hospital
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Pudong, Porcelana
- Shanghai East Hospital
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Tianjin, Porcelana
- Tianjin Cancer Hospital
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Wuhan, Porcelana
- Tongji Hospital
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Confirmed histologic diagnosis of c-Myc rearranged high-grade B-cell lymphoma
- Relapse or refractory disease after at least one previous line of therapy
- Measurable disease as defined by 2014 Lugano classification
- ECOG performance status of 0-2
- Acceptable coagulation parameters
Exclusion Criteria:
- Allogeneic transplant within 3 months
- Autologous transplant without resolution of post-transplant cytopenias
- Known CNS involvement
- Average QT/QTc interval duration > 450 msec
- Inadequate marrow, hepatic or renal function
- Unresolved Grade 2 or greater toxicities from prior anticancer therapy
- Radiotherapy within prior 4 weeks
- Requires systemic immunosuppressive therapy
- Positive for Hepatis B or Hepatis C
- Seropositive for HIV
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación Secuencial
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Cohort 1
Cohort 1 will receive a dose of 3.6 mg/m2/day of sepantronium bromide |
continuous intravenous infusion
Otros nombres:
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Experimental: Cohort 2
Cohort 1 will receive a dose of 4.8 mg/m2/day of sepantronium bromide |
continuous intravenous infusion
Otros nombres:
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Experimental: Recommended Phase 2 Dose - Cohort 3
The recommended Phase 2 dose will be established based on the safety, pharmacokinetic and pharmacodynamic data from Cohort 1 and Cohort 2 |
continuous intravenous infusion
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Safety and tolerability and recommended Phase 2 dose of sepantronium bromide
Periodo de tiempo: From time of signing informed consent through 30 days after the last dose of study drug, an average of 6 months
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Frequency, severity and relatedness of adverse events and the frequency of adverse events requiring discontinuation of study drug or dose reductions |
From time of signing informed consent through 30 days after the last dose of study drug, an average of 6 months
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Overall response rate
Periodo de tiempo: From first dose through the last dose of study drug, an average of 6 months
|
The ORR is defined as the percentage of participants who achieve either a Partial Response or Complete Response at any time during the treatment phase |
From first dose through the last dose of study drug, an average of 6 months
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Complete response rate
Periodo de tiempo: From first dose of study drug through the last dose of study drug, an average of 6 months
|
Percentage of patients who experience a confirmed Complete Response at any time during the treatment phase |
From first dose of study drug through the last dose of study drug, an average of 6 months
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Duration of response
Periodo de tiempo: From first dose of study drug through to time of progression, an average of 6 months
|
Time from the first documentation of a Complete Response or a Partial Response until the time to objective tumor progression |
From first dose of study drug through to time of progression, an average of 6 months
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Clinical benefit rate
Periodo de tiempo: From first dose of study drug through the last dose of study drug, an average of 6 months
|
Proportion of patients who achieve a Complete Response, Partial Response or Stable Disease during the treatment phase |
From first dose of study drug through the last dose of study drug, an average of 6 months
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Overall survival
Periodo de tiempo: From first dose of study drug through date of death, irrespective of cause, an average of 6 months
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The time from the first dose of study drug until death from any cause or date of last follow-up for living and lost to follow-up patients |
From first dose of study drug through date of death, irrespective of cause, an average of 6 months
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Progression Free Survival
Periodo de tiempo: From first dose of study drug through relapse, disease progression or death due to any cause, an average of 12 months
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The time from first dose until relapse, disease progression or death due to any cause |
From first dose of study drug through relapse, disease progression or death due to any cause, an average of 12 months
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Director de estudio: Vernon Jiang, PhD, Cothera Bioscience
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
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
- Procesos Patológicos
- Neoplasias
- Atributos de la enfermedad
- Enfermedades del sistema inmunológico
- Infecciones
- Enfermedades virales
- Neoplasias por tipo histológico
- Infecciones por virus de ADN
- Trastornos linfoproliferativos
- Trastornos inmunoproliferativos
- Linfoma
- Infecciones por el virus de Epstein-Barr
- Infecciones por herpesviridae
- Infecciones por virus tumorales
- Condiciones Patológicas, Signos y Síntomas
- Enfermedades hemic y linfáticas
- Reaparición
- Linfoma de células B
- Linfoma de células B grandes, difuso
- Linfoma de Burkitt
- Linfoma No Hodgkin
- Enfermedades linfáticas
- sepantronium
Otros números de identificación del estudio
- PC002-01
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices)
Marco de tiempo para compartir IPD
Beginning 9 months and ending 36 months following article publication.
Criterios de acceso compartido de IPD
Investigators whose proposed use of the data has been approved by an independent review committee ("learned intermediary") identified for this purpose.
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
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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