A Phase 2/3, Randomized, Open-Label, Comparison Study of MK-1045 Versus Blinatumomab in Participants With Relapsed or Refractory CD19+ B-Cell Acute Lymphoblastic Leukemia (B-ALL)
ESTADO CLÍNICO
Reclutando
FASE/S DEL ENSAYO
Fase II-III
PATOLOGÍA
Leucemia mieloide aguda, Terapia celular y T-CARs, Trombosis y Anticoagulantes, Linfoma, Leucemia
CENTRO INVESTIGADOR
H.G.U. Gregorio Marañón
INVESTIGADOR PRINCIPAL
Gabriela Rodríguez Macias
CENTRO INVESTIGADOR
H.U. Quirónsalud Madrid
INVESTIGADOR PRINCIPAL
Carmen Martínez Chamorro
FECHA DE APERTURA
Junio, 2026
FECHA DE CIERRE
,
CRITERIOS DE INCLUSIÓN
12 years of age.
Has a confirmed diagnosis of relapsed/refractory (R/R) B-precursor acute lymphoblastic leukemia (ALL) with 5% or more lymphoblasts in the bone marrow.
Has CD19+ disease, confirmed by local flow cytometry and/or immunohistochemistry testing at the time of enrollment.
Has Philadelphia-negative disease, confirmed by testing, at the time of enrollment.
Participants who have AEs due to previous anticancer therapies must have recovered to Grade 1 or baseline.
Has a confirmed diagnosis of relapsed/refractory (R/R) B-precursor acute lymphoblastic leukemia (ALL) with 5% or more lymphoblasts in the bone marrow.
Has CD19+ disease, confirmed by local flow cytometry and/or immunohistochemistry testing at the time of enrollment.
Has Philadelphia-negative disease, confirmed by testing, at the time of enrollment.
Participants who have AEs due to previous anticancer therapies must have recovered to Grade 1 or baseline.
CRITERIOS DE EXCLUSIÓN
Has Burkitts leukemia.
History or presence of clinically relevant central nervous system (CNS) diseases such as epilepsy, hemorrhagic/ischemic stroke, severe brain injuries, dementia, Parkinsons disease, cerebellar disease, organic brain syndrome, and psychosis.
Has active acute graft versus host disease (GvHD) or chronic GvHD. NOTE: Participants who have received CNI for GvHD within 4 weeks before the first dose of study intervention are also excluded.
History of serious cardiovascular and cerebrovascular diseases.
Has not adequately recovered from major surgery or have ongoing surgical complications.
History or presence of clinically relevant central nervous system (CNS) diseases such as epilepsy, hemorrhagic/ischemic stroke, severe brain injuries, dementia, Parkinsons disease, cerebellar disease, organic brain syndrome, and psychosis.
Has active acute graft versus host disease (GvHD) or chronic GvHD. NOTE: Participants who have received CNI for GvHD within 4 weeks before the first dose of study intervention are also excluded.
History of serious cardiovascular and cerebrovascular diseases.
Has not adequately recovered from major surgery or have ongoing surgical complications.
DESCRIPCIÓN
1. Part 1: To evaluate the RP2D and RP2D-1 of MK-1045 (target dose) with respect to CR. 2. Part 1: To evaluate the safety and tolerability of the RP2D and RP2D-1 of MK-1045. 3. Part 2: To compare MK-1045 to blinatumomab with respect to CR. 4. To compare MK-1045 to blinatumomab with respect to OS.
PALABRAS CLAVE
acute lymphoblastic leukemia, antagonistas de la vitamin k, cd19, leukemia, ph + acute lymphoblastic leukemia, vitamin k antagonist
