Real World Study of PEG-rhG-CSF in Prevention of Chemotherapy-induced Neutropenia
18 de febrero de 2019 actualizado por: CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.
Real World Study of PEGylated Recombinant Human Granulocyte Stimulating Factor(PEG-rhG-CSF) in Prevention of Chemotherapy-induced Neutropenia
The aim of this study is to observe and evaluate the cost-effectiveness,efficacy and safety of PEG-rhG-CSF in preventing chemotherapy-induced neutropenia(CIN) of cancer patients in the real world.1000
patients with non-myeloid malignancy who is planned to receive PEG-rhG-CSF for CIN prevention and 500 patients with non-myeloid malignancy who is planned to receive rhG-CSF for CIN prevention or treatment were prospectively recruited.The primary outcome was cost-effectiveness and second outcome was febrile neutropenia,the incidence and duration of grade IV neutropenia,chemotherapy delay,incidence of reduced dose of chemotherapy and relative dose intensity of chemotherapy.
Descripción general del estudio
Estado
Desconocido
Condiciones
Intervención / Tratamiento
Tipo de estudio
De observación
Inscripción (Anticipado)
1500
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Método de muestreo
Muestra no probabilística
Población de estudio
1000 patients with non-myeloid malignancy who is planned to receive PEG-rhG-CSF for CIN prevention and 500 patients with non-myeloid malignancy who is planned to receive rhG-CSF for CIN prevention or treatment were prospectively recruited.
Descripción
Inclusion Criteria:
- Patients' age≥18 years old, male or female
- Diagnosis of non-myeloid malignant solid tumors
- Patients are planned to perform chemotherapy and preventive use the PEG-rhG-CSF or preventive or therapeutic use of rhG-CSF after chemotherapy
- Patients' mental status are well, could understand the study and willing to participate the study, sign the informed consent form
- The investigator believes that patients can benefit from this study
Exclusion Criteria:
- Patients who have been confirmed to be allergic to Jinyouli® or rhG-CSF or its excipients
- Pregnant or lactating women and women who plan to be pregnant during clinical observation
- Other patients that the doctor believe not suitable for inclusion
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
|
PEG-rhG-CSF group
This group comprised 1000 patients who received a single subcutaneous injection of PEG-rhG-CSF 24 hours after the end of chemotherapy for each chemotherapy cycle.
The dose of PEG-rhG-CSF is determined by the patients' body weight, patients with body weight ≥45 kg is given to PEG-rhG-CSF 6 mg each time, patients<45 kg is given to PEG-rhG-CSF 3 mg each time.
|
PEG-rhG-CSF was administered 24 hours after the end of chemotherapy for each chemotherapy cycle.
Otros nombres:
|
|
rhG-CSF group
This group comprised 500 patients who received rhG-CSF 5 μg/kg/day by subcutaneous injection 24 hours after the end of chemotherapy or the appearance of CIN until the ANC was ≥2.0x109/L for each chemotherapy cycle.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Cost-Effectiveness
Periodo de tiempo: through the chemotherapy cycles of PEG-rhG-CSF or rhG-CSF treatment,an average of 3 month
|
Based on the results of the incidence of febrile neutropenia(FN) and the cost perFN in each group, the incremental cost-effectiveness ratio were estimated using the following formula: (CostA-CostB)/(OutcomeA-OutcomeB)
|
through the chemotherapy cycles of PEG-rhG-CSF or rhG-CSF treatment,an average of 3 month
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
The incidence of febrile neutropenia
Periodo de tiempo: From date of randomization until the date of the study completion,an average of 3 month
|
Febrile neutropenia (FN) is defined as oral temperature >38.3 ℃(under arm temperature >38.1 ℃) or continuous measurement of oral temperature >38℃(under arm temperature >37.8℃) in 2h, and absolute neutrophil count(ANC) <0.5×10^9/L, or expected to be <0.5×10^9/L
|
From date of randomization until the date of the study completion,an average of 3 month
|
|
The incidence of grade IV neutropenia
Periodo de tiempo: From date of randomization until the date of the study completion,an average of 3 month
|
Grade IV neutropenia is defined as the absolute neutrophil count(ANC)<0.5×10^9/L
|
From date of randomization until the date of the study completion,an average of 3 month
|
|
The duration of grade IV neutropenia in every chemotherapy cycle
Periodo de tiempo: From date of randomization until the date of the study completion,an average of 3 month
|
Defined as days when the ANC<2.0×10^9/L
occurs to the time when the ANC≥2.0×10^9/L,
take the median
|
From date of randomization until the date of the study completion,an average of 3 month
|
|
The incidence of the chemotherapy delay
Periodo de tiempo: From date of randomization until the date of the study completion,an average of 3 month
|
Chemotherapy delay is defined as the delay in starting the next planned chemotherapy for more than 3 days.
|
From date of randomization until the date of the study completion,an average of 3 month
|
|
The duration of the chemotherapy delay in every chemotherapy cycle
Periodo de tiempo: From date of randomization until the date of the study completion,an average of 3 month
|
The duration of the chemotherapy delay in every chemotherapy cycle
|
From date of randomization until the date of the study completion,an average of 3 month
|
|
The incidence of the dose reduction
Periodo de tiempo: From date of randomization until the date of the study completion,an average of 3 month
|
The incidence of the reduction of planned dose of chemotherapy
|
From date of randomization until the date of the study completion,an average of 3 month
|
|
Relative chemotherapy dose intensity in every chemotherapy cycle
Periodo de tiempo: From date of randomization until the date of the study completion,an average of 3 month
|
Relative chemotherapy dose intensity is defined as the actual chemotherapy dose the patient used divided by the planned chemotherapy dose,or the actual chemotherapy time divided by the planned chemotherapy time
|
From date of randomization until the date of the study completion,an average of 3 month
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Incidence of adverse events
Periodo de tiempo: From date of randomization until the date of the study completion,an average of 3 month
|
All adverse events will be recorded from the time of patients signing the informed consent form up to 30 days after the last Intervention drug is applied.
the adverse event that associated with the study drug will be specially recorded.
|
From date of randomization until the date of the study completion,an average of 3 month
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Anticipado)
13 de febrero de 2019
Finalización primaria (Anticipado)
1 de abril de 2020
Finalización del estudio (Anticipado)
1 de octubre de 2020
Fechas de registro del estudio
Enviado por primera vez
14 de febrero de 2019
Primero enviado que cumplió con los criterios de control de calidad
18 de febrero de 2019
Publicado por primera vez (Actual)
19 de febrero de 2019
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
19 de febrero de 2019
Última actualización enviada que cumplió con los criterios de control de calidad
18 de febrero de 2019
Última verificación
1 de febrero de 2019
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- CSPC-JYL-RWS-07
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Descripción del plan IPD
IPD will only be shared by the investigators in this study
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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