Calendario›BLRX›BL-8040

BL-8040

Safety, Tolerability and Efficacy of the BL-8040 and Atezolizumab for Maintenance Treatment in Subjects With Acute Myeloid Leukemia (AML)

Ensayo de BioLineRx Ltd. en Leucemia mieloide aguda.

Más ensayos de: Leucemia mieloide aguda.

Fase

Fase 1/2

Estado

Interrumpido

Participantes

1

previstos

Centros

12

Fin del objetivo primario

abr 2020

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, de un solo grupo, abierto. Comenzó en ene 2018.

Este ensayo se detuvo. Motivo declarado por el promotor (del registro, en inglés): «Due to lack of enrollment».

Qué mide

Relapse Free Survival (del registro, en inglés) (hasta 5 años)

Cómo lo describe el promotor

En el documentoEn inglés, del registroA Phase Ib/II, Multicenter, Single Arm, Open-Label Study, To Evaluate the Safety, Tolerability and Efficacy of the BL-8040 and Atezolizumab Combination for Maintenance Treatment in Subjects with Acute Myeloid Leukemia- The BATTLE Study The main goal of this clinical trial is to assess the safety and tolerability of the treatment combination of BL-8040 and Atezolizumab as Maintenance Treatment in Subjects with Acute Myeloid Leukemia. Additional objectives are: Assessment of the effect of combination of BL-8040 and Atezolizumab on relapse free survival (RFS) Assessment whether the treatment combination of BL-8040 and Atezolizumab can reduce the Minimal Residual Disease (MRD) as compared to baseline Assessment of the Overall Survival (OS) time in subjects treated with the combination of BL-8040 and Atezolizumab for maintenance Assessment of the Event Free Survival (EFS) time in subjects treated with the combination of BL-8040 and Atezolizumab for maintenance

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Todos los de BLRX, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT03154827), actualizada en ago 2024.