Calendario›GILD›Idelalisib
Idelalisib
Efficacy and Safety of Idelalisib in Combination With Obinutuzumab Compared to Chlorambucil in Combination With Obinutuzumab for Previously Untreated Chronic Lymphocytic Leukemia
Ensayo de GILEAD SCIENCES, INC. en Leucemia linfocitica cronica.
Más ensayos de: Leucemia linfocítica crónica.
- Fase
- Fase 3
- Estado
- Interrumpido
- Participantes
- 57
- Centros
- 18
- Fin del objetivo primario
- may 2016
previstos
fecha real
Qué significa cada fase y cada estado.
Estudio de intervención, aleatorizado, abierto. Comenzó en abr 2015.
Qué mide
Supervivencia libre de progresion (hasta 11 meses)
Cómo lo describe el promotor
En el documentoEn inglés, del registroThe primary objective of this study is to evaluate the effects of idelalisib with obinutuzumab versus the combination of chlorambucil and obinutuzumab on progression-free survival (PFS) in participants with previously untreated chronic lymphocytic leukemia (CLL). An increased rate of deaths and serious adverse events (SAEs) among participants with front-line CLL and early-line indolent non-Hodgkin lymphoma (iNHL) treated with idelalisib in combination with standard therapies was observed by the independent data monitoring committee (DMC) during regular review of 3 Gilead Phase 3 studies. Gilead reviewed the unblinded data and terminated those studies in agreement with the DMC recommendation and in consultation with the US Food and Drug Administration (FDA). All front-line studies of idelalisib, including this study, were also terminated.
Más ensayos de GILD
| Ensayo | Fase | Estado | Lectura de resultados |
|---|---|---|---|
| Tenofovir DF | Fase 3 | En marcha, sin reclutar | ago 2017 (real) |
| Oral Lenacapavir · CAPELLA | Fase 2/3 | En marcha, sin reclutar | oct 2020 (real) |
| Sacituzumab Govitecan-hziy | Fase 2 | En marcha, sin reclutar | ago 2021 (real) |
| Sacituzumab Govitecan-hziy · EVOKE-01 | Fase 3 | En marcha, sin reclutar | nov 2023 (real) |
| ISL | Fase 2 | En marcha, sin reclutar | dic 2023 (real) |
| Oral Lenacapavir · PURPOSE 1 | Fase 3 | En marcha, sin reclutar | may 2024 (real) |
Todos los de GILD, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT01980875), actualizada en oct 2018.