Calendario›REGN›FLORA
FLORA
Real-World Clinical Outcomes in Adult Patients Who Initiate Systemic Treatment for Relapsed or Refractory Follicular Lymphoma
Ensayo de REGENERON PHARMACEUTICALS, INC. en Relapsed/Refractory Follicular Lymphoma (del registro, en inglés).
- Fase
- no aplica
- Estado
- Completado
- Participantes
- 247
- Centros
- 9
- Fin del objetivo primario
- oct 2023
previstos
fecha real
Qué significa cada fase y cada estado.
Estudio observacional. Comenzó en jun 2022.
Qué mide
Objective response rate (del registro, en inglés) (hasta 84 meses)
Cómo lo describe el promotor
En el documentoEn inglés, del registroPrimary Objective: To evaluate objective response rate (ORR) in adult patients with relapsed/refractory follicular lymphoma (r/r FL) grade 1-3a who are treated with currently available therapies in the real-world setting according to Lugano classification (Cheson, 2014) of malignant lymphoma and as assessed by independent central review. Secondary Objectives: To evaluate the following outcomes in adult patients with r/r FL grade 1-3a who are treated with currently available systemic therapies in the real-world setting: 1. Objective response rate (ORR) according to the Lugano classification and as assessed by treating physician evaluation 2. Complete response (CR) rate according to the Lugano classification and as assessed by: * Independent central review, and * Treating physician evaluation 3. Progression-free survival (PFS) according to the Lugano classification and as assessed by: * Independent central review, and * Treating physician evaluation 4. Overall survival (OS) 5. Duration of response (DOR) according to the Lugano classification and as assessed by: * Independent central review, and * Treating physician evaluation 6. Disease control rate (DCR) according to the Lugano classification and as assessed by: * Independent central review, and * Treating physician evaluation 7. Time to next treatment (TTNT) 8. Histological transformation (HT)
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Todos los de REGN, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT05338879), actualizada en oct 2023.