Relapsed or Refractory CD19+ B-Cell Acute Lymphoblastic Leukemia (B-ALL)
Conditions
Interventions
Each participant will receive the assigned study intervention for up to approximately 74 weeks (MK-1045) or 78 weeks (blinatumomab).
Sponsors
Fujita Tomoko
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion 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).
Exclusion criteria
Exclusion 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Australia, Brazil, Canada, Chile, China, Denmark, France, Greece, Israel, Italy, Japan, Mexico, Netherlands, New Zealand, Spain, Sweden, United States of America
Contacts
Public ContactMSDJRCT inquiry mailbox
MSD K.K.
Outcome results
None listed