NIPH Clinical Trials Search

MK-1045 Versus Blinatumomab in CD19+ B-Cell Acute Lymphoblastic Leukemia

Basic Information

Recruitment status	Pending
Health condition(s) or Problem(s) studied	Relapsed or Refractory CD19+ B-Cell Acute Lymphoblastic Leukemia (B-ALL)
Date of first enrollment	19/06/2026
Target sample size	21
Countries of recruitment	United States of America,Japan,Canada,Japan,Australia,Japan,New Zealand,Japan,China,Japan,Brazil,Japan,Chile,Japan,Mexico,Japan,Denmark,Japan,France,Japan,Greece,Japan,Italy,Japan,Netherlands,Japan,Spain,Japan,Sweden,Japan,Israel,Japan
Study type	Interventional
Intervention(s)	Each participant will receive the assigned study intervention for up to approximately 74 weeks (MK-1045) or 78 weeks (blinatumomab).

Outcome(s)

Primary Outcome

Part 1 -CR within the first 3 treatment cycles -AEs -Discontinuation of study intervention due to an AE Part 2 -CR within the first 3 treatment cycles -OS: the time from randomization to death due to any cause

Secondary Outcome

Part 1 -OS: the time from randomization to death due to any cause -MRD negativity within the first 3 treatment cycles -CR or CRh or CRi within the first 3 treatment cycles Part 2 -MRD negativity within the first 3 treatment cycles -CR or CRh within the first 3 treatment cycles -CR or CRh or CRi within the first 3 treatment cycles -Duration of CR -Duration of CR/CRh -Duration of CR/CRh/CRi -EFS -allo-HSCT -AEs -Discontinuation of study intervention due to an AE

Key inclusion & exclusion criteria

Age minimum	>= 12age old
Age maximum	Not applicable
Gender	Both
Include criteria	- 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. - Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART).
Exclude criteria	- Has Burkitt's leukemia. - History or presence of clinically relevant central nervous system (CNS) diseases such as epilepsy, hemorrhagic/ischemic stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, and psychosis. - Has active acute graft versus host disease (GvHD), Grade 2 to 4 according to the Glucksberg criteria or active chronic GvHD requiring systemic treatment. - History of serious cardiovascular and cerebrovascular diseases. - HIV-infection with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease. - Received prior treatment with blinatumomab within 12 weeks for Part 1 and 24 weeks for Part 2 before the first dose of study intervention (individuals known to be refractory or intolerant to blinatumomab are to be excluded). - Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study intervention. - Known additional malignancy that is progressing or has required active treatment within the past 2 years. - Isolated extramedullary disease (EMD). - Active autoimmune disease unrelated to ALL that has required systemic treatment in the past 2 years or history of autoimmune disease with potential CNS involvement. - Active infection requiring systemic therapy. - Has not adequately recovered from major surgery or have ongoing surgical complications.