Calendario›AMGN›blinatumomab
blinatumomab
A Phase 1b Open-Label Study Investigating the Safety and Pharmacokinetics of Administration of Subcutaneous Blinatumomab for the Treatment of Relapsed/Refractory Indolent Non-Hodgkin's Lymphoma
Ensayo de AMGEN INC en Linfoma no Hodgkin.
Más ensayos de: Linfoma no Hodgkin.
- Fase
- Fase 1
- Estado
- Completado
- Participantes
- 35
- Centros
- 17
- Fin del objetivo primario
- sep 2021
previstos
fecha real
Qué significa cada fase y cada estado.
Estudio de intervención, de un solo grupo, abierto. Comenzó en sep 2017.
Qué mide
Number of Participants With Dose Limiting-Toxicities (DLTs) After SC Administration (Day 1 to Day 7 of Week 4) (del registro, en inglés)
Cómo lo describe el promotor
En el documentoEn inglés, del registroPrimary Objective: • To evaluate the safety and tolerability of subcutaneous (SC) blinatumomab dose administrations Secondary Objectives: * To determine pharmacokinetics (PK) with continuous intravenous (cIV) and SC administrations * To estimate the maximum tolerated dose (MTD) tested for blinatumomab administered subcutaneously * To determine the incidence of anti-blinatumomab antibody formation following SC administration * To evaluate efficacy response following treatment with SC blinatumomab administration Exploratory Objective: * To determine the pharmacodynamics (PD) time profiles for B-and T-lymphocytes as well as cytokine profiles during SC administration * To evaluate efficacy response following treatment with SC blinatumomab administration using Lugano criteria if positron emission tomography-computed tomography (PET/CT) is used for evaluation
Más ensayos de AMGN
| Ensayo | Fase | Estado | Lectura de resultados |
|---|---|---|---|
| Inebilizumab | Fase 3 | En marcha, sin reclutar | abr 2024 (real) |
| inebilizumab · MINT | Fase 3 | En marcha, sin reclutar | may 2024 (real) |
| Tarlatamab · DeLLphi-304 | Fase 3 | En marcha, sin reclutar | ene 2025 (real) |
| Tarlatamab · DeLLphi-307 | Fase 2 | En marcha, sin reclutar | mar 2025 (real) |
| Maridebart Cafraglutide | Fase 2 | En marcha, sin reclutar | oct 2025 (real) |
| Erenumab Dose 1 · OASIS(EM) | Fase 3 | En marcha, sin reclutar | nov 2025 (real) |
Todos los de AMGN, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT02961881), actualizada en may 2023.