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A Clinical Trial of MK-1045 in People With B-cell Acute Lymphoblastic Leukemia (MK-1045-005)
Sponsor: Merck Sharp & Dohme LLC
Summary
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.
Official title: 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)
Key Details
Gender
All
Age Range
12 Years - Any
Study Type
INTERVENTIONAL
Enrollment
340
Start Date
2026-05-08
Completion Date
2029-10-02
Last Updated
2026-05-06
Healthy Volunteers
No
Conditions
Interventions
MK-1045
Intravenous administration
Blinatumomab
Intravenous administration
Acetaminophen
Oral administration as a premedication
Diphenhydramine
Intravenous administration as a premedication
Dexamethasone
Intravenous administration as a premedication
Tocilizumab
Intravenous administration as a rescue medication
Siltuximab
Intravenous administration as a rescue medication
Avtozma
Intravenous administration as a rescue medication
Tyenne
Intravenous administration as a rescue medication