Researchers are looking for new ways to treat people with relapsed or refractory B-cell acute lymphoblastic leukemia (R/R B-ALL) that is CD19 positive using a medicine called MK-1045. MK-1045 is an immunotherapy, which is a treatment that helps the immune system fight cancer. This trial will compare MK-1045 to a standard immunotherapy called blinatumomab. The goals of this trial are to learn if more people who receive MK-1045 have no cancer cells in their bone marrow compared to people who receive blinatumomab and if people who receive MK-1045 live longer compared to people who receive blinatumomab.
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 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) 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.
Parallel
MK-1045
Biological/VaccineIntravenous administration
Blinatumomab
Biological/VaccineIntravenous administration
Acetaminophen
DrugOral administration as a premedication
Diphenhydramine
DrugIntravenous administration as a premedication
Dexamethasone
DrugIntravenous administration as a premedication
Tocilizumab
DrugIntravenous administration as a rescue medication
Siltuximab
DrugIntravenous administration as a rescue medication
Avtozma
DrugIntravenous administration as a rescue medication
Tyenne
DrugIntravenous administration as a rescue medication
Percentage of Participants with Complete Remission (CR) in Study Part 1 and Part 2
CR is defined as: * No circulating lymphoblasts * Extramedullary disease negative * Trilineage hematopoiesis (TLH) and \<5% leukemic blasts * Absolute neutrophil count (ANC) ≥1000/μL * Platelets ≥100,000/μL * No platelet transfusions in the last 7 days * No administration of short-acting granulocyte colony-stimulating factor (G-CSF) and long-acting G-CSF in the last 3 and 14 days, respectively
Percentage of Participants Who Experience an Adverse Event (AE) in Study Part 1
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants with at least 1 AE will be presented.
Percentage of Participants Who Discontinue Study Intervention Due to an AE in Study Part 1
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants who discontinue study intervention due to an AE will be presented.
Overall Survival (OS) in Study Part 2
OS is the time from randomization to death due to any cause.
Overall survival (OS) in Study Part 1
OS is the time from randomization to death due to any cause.
Percentage of Participants that achieve Minimal Residual Disease (MRD) in Study Part 1 and Part 2
MRD is defined as no detectable leukemia cells below a threshold of at least 10\^-4.
Percentage of Participants that achieve CR/CR with partial hematologic recovery (CRh)/CR with incomplete count recovery (CRi) in Study Part 1 and Part 2
For participants who demonstrate CR or CRh or CRi, duration of remission is defined as the time from the first documented evidence of CR or CRh or CRi (whichever is earlier) until disease progression, relapse, or death due to any cause, whichever occurs first. CR is defined as: * No circulating lymphoblasts * Extramedullary disease negative * Trilineage hematopoiesis (TLH) and \<5% leukemic blasts * Absolute neutrophil count (ANC) ≥1000/μL * Platelets ≥100,000/μL * No platelet transfusions in the last 7 days * No administration of short-acting granulocyte colony-stimulating factor (G-CSF) and long-acting G-CSF in the last 3 and 14 days, respectively CRh is the same as CR but with less stringent requirements for platelet count (≥50,000/μL) and ANC (≥500/μL). CRi is the same as CR but without recovery of platelet count or without recovery of ANC (platelets \<100,000/μL and ANC ≥1000/μL or platelets ≥100,000/μL and ANC \<1000/μL.
Percentage of Participants with CR or CRh in Study Part 2
The percentage of participants who meet either CR or CRh requirements will be presented. CR is defined as: * No circulating lymphoblasts * Extramedullary disease negative * Trilineage hematopoiesis (TLH) and \<5% leukemic blasts * Absolute neutrophil count (ANC) ≥1000/μL * Platelets ≥100,000/μL * No platelet transfusions in the last 7 days * No administration of short-acting granulocyte colony-stimulating factor (G-CSF) and long-acting G-CSF in the last 3 and 14 days, respectively CRh is the same as CR but with less stringent requirements for platelet count (≥50,000/μL) and ANC (≥500/μL).
Click on the lead sponsor to view all of their trials.