Un estudio de JNJ-88998377 para el linfoma no Hodgkin de células B en recaída o refractario
Un estudio de fase 1, el primero en humanos, de aumento de dosis de JNJ-88998377 en participantes con linfoma no Hodgkin (NHL) de células B en recaída o refractario
The main purpose of this study is to characterize safety and to determine the recommended phase 2 dose (RP2D) for JNJ-88998377 (Part A: Dose Escalation), to further assess the safety of JNJ-88998377 at the RP2D (Part B: Dose Expansion).
Descripción general del estudio
Estado
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 1
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
-
Seoul, Corea del Sur, 03080
- Seoul National University Hospital
-
Seoul, Corea del Sur, 06351
- Samsung Medical Center
-
-
-
-
-
Bologna, Italia, 40138
- A O U Sant Orsola Malpighi
-
-
-
-
-
Chūōku, Japón, 104 0045
- National Cancer Center Hospital
-
Kashiwa, Japón, 277-8577
- National Cancer Center Hospital East
-
Tokyo, Japón, 135 8550
- The Cancer Institute Hospital of JFCR
-
-
-
-
-
Katowice, Polonia, 40 519
- Pratia Onkologia Katowice
-
Kielce, Polonia, 25-734
- Swietokrzyskie Centrum Onkologii SPZOZ w Kielcach, Klinika Hematologii i Transplantacji Szpiku
-
Skorzewo, Polonia, 60-185
- Aidport Sp z o o
-
-
-
-
-
Beijing, Porcelana, 100142
- Beijing Cancer Hospital
-
Guangzhou, Porcelana, 510062
- Sun Yat Sen University Cancer Center
-
Hangzhou, Porcelana, 310002
- The First Affiliated Hospital Zhejiang University College of Medicine
-
Shanghai, Porcelana, 200032
- Fudan University Shanghai Cancer Center
-
Tianjin, Porcelana, 300181
- Tianjin Medical University Cancer Institute and Hospital
-
-
-
-
-
Taipei, Taiwán, 10043
- National Taiwan University Hospital
-
Taoyuan, Taiwán, 33382
- Linkou Chang Gung Memorial Hospital
-
-
-
-
-
Ankara, Turquía (Türkiye), 06200
- SBU Ankara Dr. Abdurrahman Yurtaslan Onkoloji Egitim ve Arastirma Hastanesi Faz 1 Merkezi
-
Ankara, Turquía (Türkiye), 06620
- Ankara Universitesi Hastaneleri Tibbi Farmakoloji Anabilim Dali Faz 1 Klinik Arastirma Merkezi
-
Istanbul, Turquía (Türkiye), 34010
- Koc Universitesi Hastanesi Faz 1 Klinik Arastirma Merkezi
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Participants have histologically or cytologically confirmed B-cell non-Hodgkin's Lymphoma (NHL) according to the 2022 World Health Organization (WHO) classification with relapsed or refractory disease
- Participants have measurable disease or meet all requirements for adequate response assessment as defined by the appropriate disease response criteria at screening
- Participants have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Participants have a life expectancy of greater than or equal to (>=) 12 weeks
- Be willing and able to adhere to the lifestyle restrictions specified in the protocol
Exclusion Criteria:
- Participant with active or prior history of B-cell NHL involving the central nervous system (CNS) and leptomeningeal involvement
- History of malignancy (other than the disease under study in the cohort to which the participant is assigned) within 1 year prior to the first administration of study treatment.
- For Part A and B: Participant having known allergies, hypersensitivity, or intolerance to the excipients of JNJ-88998377
- Participant had major surgery or had significant traumatic injury within 30 days before first dose of study treatment or has not recovered from surgery and must not have major surgery planned during the time the participant is receiving study treatment
- Participant received an autologous stem cell transplant less than or equal to (<=) 3 months before the first dose of study treatment
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 |
|---|---|
|
Experimental: Part A: Dose Escalation
Participants will receive JNJ-88998377 at a selected starting dose. Subsequent dose levels and schedules will be selected based on the review of all available data to establish recommended Phase 2 dose (RP2D). |
JNJ-88998377 will be administered. |
|
Experimental: Part B: Dose Expansion
Participants will receive JNJ-88998377 at RP2D determined in Part A. Additional expansion cohort(s) may be added with a lower RP2D(s), or different dose schedule(s) based on all available data. |
JNJ-88998377 will be administered. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Parts A and B: Number of Participants with Adverse Events (AEs)
Periodo de tiempo: Upto 3 years 4 months
|
An AE is any untoward medical occurrence in a participant administered a pharmaceutical (investigational or non-investigational) product. It does not necessarily have a causal relationship with the investigational product. |
Upto 3 years 4 months
|
|
Part A: Number of Participants with Dose Limiting Toxicity (DLTs)
Periodo de tiempo: Cycle 1 (21 days)
|
Number of participant with DLT will be assessed. The DLTs are specific adverse events and are defined as any of the following: high grade non-hematological or hematological toxicity. |
Cycle 1 (21 days)
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Plasma Concentration of JNJ-88998377
Periodo de tiempo: Up to first 12 weeks
|
Plasma concentration of oral dose of JNJ-88998377 will be assessed. |
Up to first 12 weeks
|
|
Area Under the Plasma Concentration Versus Time Curve During A Dosing Interval (τ) At Steady-State of JNJ-88998377
Periodo de tiempo: Up to first 12 weeks
|
Area under the plasma concentration versus time curve during a dosing interval (τ) at steady-state concentration of JNJ-88998377 will be reported. |
Up to first 12 weeks
|
|
Maximum Plasma Concentration (Cmax) of JNJ-88998377
Periodo de tiempo: Up to first 12 weeks
|
Cmax of JNJ-88998377 will be reported. |
Up to first 12 weeks
|
|
Minimum Plasma Drug Concentration (Cmin) of JNJ-88998377
Periodo de tiempo: Up to first 12 weeks
|
Cmin of JNJ-88998377 will be reported. |
Up to first 12 weeks
|
|
Percentage of Participants With Overall Response (OR)
Periodo de tiempo: Up to 3 years 4 months
|
OR is defined as the percentage of participants who have a best response of partial response (PR) or better per investigator assessment according to disease-specific response criteria. |
Up to 3 years 4 months
|
|
Time to Response (TTR)
Periodo de tiempo: From first dose of study treatment until first response of PR or better (up to 3 years and 4 months)
|
TTR is defined for participants who achieved a response of PR or better as the time from the first dose of study treatment to the first response of PR or better per investigator assessment according to disease-specific response criteria. |
From first dose of study treatment until first response of PR or better (up to 3 years and 4 months)
|
|
Duration of Response (DOR)
Periodo de tiempo: From date of documentation of first response of PR or better until progressive disease or death (up to 3 years and 4 months)
|
DOR is defined for participants who achieved a response of PR or better as the time between the date of initial documentation of first response of PR or better to the date of first documented evidence of progressive disease or death. |
From date of documentation of first response of PR or better until progressive disease or death (up to 3 years and 4 months)
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Director de estudio: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
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
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 88998377LYM1001
- 88998377LYM1001 (Otro identificador: Janssen Research & Development, LLC)
- 2023-509258-71-00 (Identificador de registro: EUCT number)
- 2023 (Subvención/contrato del NIH de EE. UU.)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
The data sharing policy of Johnson & Johnson Innovative Medicine is available at innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
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.
producto fabricado y exportado desde los EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .