Ziftomenib

Studies to Assess Ziftomenib in Combination With Ven+Aza or 7+3 in Patients With Untreated NPM1-m or KMT2A-r AML

Ensayo de Kura Oncology, Inc. en Leucemia mieloide aguda (LMA).

Más ensayos de: Leucemia mieloide aguda.

Fase: Fase 3
Estado: Reclutando pacientes
Participantes: 1.300
Centros: 115
Fin del objetivo primario: nov 2031

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, cuádruple ciego. Comenzó en sep 2025.

Qué mide

Estudio de terapia no intensiva: (Criterio de valoracion principal para todos los paises): Supervivencia global (SG) (Defined as the time from randomization to date of death from any cause, assessed up to 36 months after last patient inclusion) (del registro, en inglés)

Qué se prueba

Se investiga anadir ziftomenib, o un placebo, a tratamientos estandar en pacientes con leucemia mieloide aguda no tratada previamente que tienen ciertas mutaciones geneticas, en dos estudios paralelos con doble ciego.

Lo que dice el documentoThis protocol has 2 separate studies that will investigate the benefits and risks of adding ziftomenib to standard-of-care (SOC) AML treatments in patients with certain genetic mutations who have not received any treatment for their AML. In the first study, the Nonintensive Therapy Study, older patients or those with serious medical problems will receive the SOC therapies venetoclax (ven) and azacitidine (aza), plus either ziftomenib or a placebo.

Traducción automática (claude-sonnet-5). Lo comprobado es la cita: está literal en el documento y sus cifras cuadran con las de la frase. Todavía no la ha leído una persona.

Cómo lo describe el promotor

En el documentoEn inglés, del registroZiftomenib is an investigational drug in development for the treatment of patients with acute myeloid leukemia (AML) with eligible genetic alterations. Ziftomenib is a type of therapy known to target the menin pathway in cancer cells. This protocol has 2 separate studies that will investigate the benefits and risks of adding ziftomenib to standard-of-care (SOC) AML treatments in patients with certain genetic mutations who have not received any treatment for their AML. In the first study, the Nonintensive Therapy Study, older patients or those with serious medical problems will receive the SOC therapies venetoclax (ven) and azacitidine (aza), plus either ziftomenib or a placebo. In the second study, the Intensive Therapy Study, medically fit patients will receive (a) the SOC therapies cytarabine and daunorubicin, plus either ziftomenib or a placebo during a first treatment phase called induction, (b) cytarabine plus either ziftomenib or a placebo during a second treatment phase called consolidation, and (c) ziftomenib or a placebo during a third treatment phase called maintenance. The physician will determine which study is the appropriate treatment for the patient, but neither the patient nor their physician will know whether the patient has been assigned to receive ziftomenib or a placebo. This design is called "double-blinded".

Más ensayos de KURA

Ensayo	Fase	Estado	Lectura de resultados
Ziftomenib	Fase 1	Reclutando pacientes	dic 2026 (prevista)
Darlifarnib · FIT-001	Fase 1	Reclutando pacientes	ene 2027 (prevista)
ziftomenib	Fase 1	Reclutando pacientes	dic 2027 (prevista)
Ziftomenib	Fase 1/2	En marcha, sin reclutar	oct 2028 (prevista)
Ziftomenib	Fase 1	Reclutando pacientes	abr 2030 (prevista)
ziftomenib	no aplica	Disponible por acceso ampliado	sin fecha

Todos los de KURA, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT07007312), actualizada en ago 2026.