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Flotetuzumab 3 ng · VOYAGE

Flotetuzumab in Primary Induction Failure (PIF) or Early Relapse (ER) Acute Myeloid Leukemia (AML)

Ensayo de MACROGENICS INC en Leucemia mieloide aguda.

Más ensayos de: Leucemia mieloide aguda.

Fase

Fase 1/2

Estado

Interrumpido

Participantes

244

previstos

Centros

43

Fin del objetivo primario

jul 2022

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, no aleatorizado, abierto. Comenzó en jun 2014.

Este ensayo se detuvo. Motivo declarado por el promotor (del registro, en inglés): «Business decision».

Qué mide

Efficacy Based on CR or CRh Rate (del registro, en inglés) (hasta 14 meses)

Cómo lo describe el promotor

En el documentoEn inglés, del registroOpen-label, multi-dose, single-arm, multi-center, Phase 1/2 study conducted in three segments: the Single Patient Dose Escalation Segment (complete), followed by the Multi-Patient Dose Escalation Segment (complete) and the Maximum Tolerated Dose and Schedule (MTDS) Expansion Cohort Segment (closed). Having characterized safety and determined the maximum tolerated dose and schedule, the primary objective of this study now is to assess the anti-neoplastic activity of flotetuzumab in patients with PIF/ER AML, as determined by the proportion of patients who achieve CR or CRh. Starting with Cycle 2, patients who are benefiting from flotetuzumab may receive up to a maximum of 8 cycles of treatment. Patients will receive daily increasing doses of flotetuzumab for the first week of Cycle 1 (Lead-In Dosing) followed by 3 weeks of continuous intravenous infusion at a the assigned dose. Subsequent cycles are each 4 weeks of continuous infusion at the assigned dose. Dosing may continue for up to 8 cycles. Follow up visits may continue for 6 months after treatment is discontinued.

Más ensayos de MGNX

Todos los de MGNX, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT02152956), actualizada en ene 2024.