Calendario›REGN›ORCHID
ORCHID
Real-World Clinical Outcomes in Adult Patients Who Initiate Systemic Treatment for Relapsed/Refractory Diffuse Large B-Cell Lymphoma
Ensayo de REGENERON PHARMACEUTICALS, INC. en Diffuse Large B-Cell Lymphoma (del registro, en inglés).
- Fase
- no aplica
- Estado
- Completado
- Participantes
- 595
- 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 Diffuse Large B-Cell Lymphoma (r/r DLBCL) who receive systemic treatment after at least 2 prior systemic therapies in the real-world setting according to Lugano classification of malignant lymphoma (Cheson, 2014) and as assessed by independent central review Secondary Objectives: To evaluate the following outcomes in adult patients with r/r DLBCL who are treated with currently available therapies in the real-world setting: 1. ORR according to Lugano classification and as assessed by treating physician evaluation 2. Complete Response (CR) rate according to Lugano classification and as assessed by: * Independent central review, and * Treating physician evaluation 3. Progression Free Survival (PFS) according to Lugano classification and as assessed by: * Independent central review, and * Treating physician evaluation 4. Overall Survival (OS) 5. Duration of response (DOR) according to Lugano classification and as assessed by * Independent central review and * Treating physician evaluation 6. Disease control rate (DCR) according to Lugano classification and as assessed by: * Independent central reviewed * Treating physician evaluation 7. Time to next treatment (TTNT)
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Todos los de REGN, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT05338892), actualizada en oct 2023.