Calendario›GILD›Idelalisib

Idelalisib

A Study of Idelalisib and Rituximab in Elderly Patients With Untreated CLL or SLL

Ensayo de GILEAD SCIENCES, INC. en Chronic Lymphocytic Leukemia (CLL) · Small Lymphocytic Lymphoma (SLL) (del registro, en inglés).

Más ensayos de: Leucemia linfocítica crónica.

Fase

Fase 2

Estado

Interrumpido

Participantes

105

previstos

Centros

6

Fin del objetivo primario

ago 2015

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, de un solo grupo, abierto. Comenzó en oct 2010.

Qué mide

Overall Response Rate (ORR) (del registro, en inglés) (hasta 28 meses)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThis study is to evaluate the safety and clinical activity of idelalisib alone and in combination with rituximab in patients with CLL or SLL. This Phase 2 study will be the first time that idelalisib is administered to previously untreated patients with hematologic malignancies. Idelalisib has demonstrated clinical activity as a single agent in relapsed or refractory CLL and SLL with acceptable toxicity, which supports its evaluation in previously untreated patients. The study population is limited to patients over 65 years of age because younger patients are generally appropriate for standard immunochemotherapy regimens that are highly active. Since the mechanism of action of idelalisib is distinct from rituximab, it is hypothesized that the combination will be more active than either agent alone. This study will establish initial safety and clinical activity of idelalisib in combination with rituximab in patients with CLL or SLL. Cohort 2 of this study will establish safety and clinical activity of idelalisib alone in subjects with untreated CLL or SLL.

Más ensayos de GILD

Todos los de GILD, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT01203930), actualizada en oct 2018.