Tests MK-1045 against blinatumomab in B-cell leukemia that returned or resisted treatment
Compares MK-1045 with blinatumomab in people 12 or older with CD19-positive B-cell leukemia.
Plain-language title generated from the registry record
Registry title: A Clinical Trial of MK-1045 in People With B-cell Acute Lymphoblastic Leukemia (MK-1045-005)
Key facts
- Where
- Aalborg, Aarhus N, Copenhagen Oe, and Odense C, DenmarkSee the 4 sites
- Phase
- Phase 2/3
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for people aged 12 or older whose CD19-positive B-cell acute lymphoblastic leukemia came back or did not respond to treatment. It compares MK-1045 with blinatumomab.
- Age
- 12 years or older
- Sex
- All sexes can join.
- Disease stage
- Relapsed or refractory B-precursor acute lymphoblastic leukemia (ALL) with 5% or more lymphoblasts in the bone marrow. The disease must be CD19+ and Philadelphia-negative.
- Earlier treatment
- Side effects from earlier cancer treatments must have recovered to Grade ≤1 or baseline. People who had blinatumomab within 12 weeks (Part 1) or 24 weeks (Part 2) before the first dose cannot join. People known to be refractory or intolerant to blinatumomab cannot join.
- Biomarker or test result
- CD19+ disease, confirmed by local flow cytometry and/or immunohistochemistry testing. Philadelphia-negative disease, confirmed by testing.
Main reasons for not taking part
- Burkitt's leukemia
- Isolated extramedullary disease (EMD)
- Active acute or chronic graft versus host disease (GvHD)
- Clinically relevant central nervous system (CNS) disease, or serious cardiovascular or cerebrovascular disease
- Active infection needing systemic therapy, or active autoimmune disease needing systemic treatment in the past 2 years
Read by machine on 11 November 2026.
Where in Denmark
- Aalborg University HospitalAalborg, DenmarkTaking people
- Region MidtjyllandAarhus N, DenmarkTaking people
- RigshospitaletCopenhagen Oe, DenmarkTaking people
- Odense University HospitalOdense C, DenmarkTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Merck Sharp & Dohme LLC
- Trial code
- NCT07570173EU 2025-522267-15-00
- Record updated
- 10 November 2026
- Original description
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.Read full original descriptionShow less
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)
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.
Inclusion: 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: 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; 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). Refractory to blinatumomab is defined as failure to achieve a response after at least 2 cycles of previous blinatumomab treatment; 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; 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, Parkinson's disease, cerebellar disease, organic brain syndrome, and psychosis; History of serious cardiovascular and cerebrovascular diseases; HIV-infection with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease; 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 Burkitt's leukemia.