Actively Recruiting
A Phase 2/3 Randomized Study Comparing MK-1045 to Blinatumomab in Relapsed or Refractory CD19+ B-Cell Acute Lymphoblastic Leukemia
Led by Merck Sharp & Dohme LLC · Updated on 2026-06-05
340
Participants Needed
3
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
Researchers are evaluating new treatments for people aged 12 and older with relapsed or refractory B-cell acute lymphoblastic leukemia (R/R B-ALL) that tests positive for CD19. This trial compares an immunotherapy drug called MK-1045 with a standard immunotherapy called blinatumomab. The study aims to find out if MK-1045 can help more people achieve complete remission and live longer than those receiving blinatumomab. It includes a dose optimization phase followed by a randomized comparison of the two treatments. The study has two parts: Part 1 focuses on finding the best dose of MK-1045, giving participants either a lower or higher dose once weekly for up to 13 cycles, each cycle lasting 28 or 42 days. Participants may switch treatments after Part 1. In Part 2, participants are randomly assigned to receive MK-1045 at the recommended dose or blinatumomab, which is given on days 1, 8, 15, and 22 of each 42-day cycle. Some participants also receive premedications like acetaminophen, diphenhydramine, and dexamethasone, and rescue medications such as tocilizumab if needed. During the study, participants will have regular assessments to monitor cancer response, adverse events, and overall survival for up to about 7 years. Researchers will measure remission rates, minimal residual disease, treatment side effects, and how long remission lasts. Participants will receive intravenous treatments and attend scheduled visits for evaluations including bone marrow tests. Safety monitoring and long-term follow-up are part of the trial to better understand the effects of MK-1045 and blinatumomab in this condition.
CONDITIONS
Brief Title
A Clinical Trial of MK-1045 in People With B-cell Acute Lymphoblastic Leukemia (MK-1045-005)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed diagnosis of relapsed or refractory B-precursor acute lymphoblastic leukemia with 5% or more lymphoblasts in bone marrow
- CD19 positive disease confirmed by testing at enrollment
- Philadelphia-negative disease confirmed by testing at enrollment
- Recovery to Grade 1 or baseline from adverse events related to prior anticancer therapies
- Well controlled HIV infection on antiretroviral therapy (if applicable)
You will not qualify if you...
- Diagnosis of Burkitt's leukemia
- History or presence of serious central nervous system diseases such as epilepsy, stroke, severe brain injury, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis
- Active acute or chronic graft versus host disease or recent use of calcineurin inhibitors for GvHD
- History of serious cardiovascular or cerebrovascular diseases
- HIV infection with history of Kaposi's sarcoma or Multicentric Castleman's Disease
- Prior treatment with blinatumomab within 12 weeks (Part 1) or 24 weeks (Part 2) before study
- Immunodeficiency or current chronic systemic steroid or immunosuppressive therapy
- Additional malignancy progressing or requiring treatment within past 2 years
- Isolated extramedullary disease
- Active autoimmune disease requiring recent systemic treatment or history of autoimmune disease involving the central nervous system
- Active infection requiring systemic therapy
- Not fully recovered from major surgery or have ongoing surgical complications
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 126 days (3 treatment cycles; cycle lengths vary between arms)
Participants receive intravenous MK-1045 or blinatumomab to treat relapsed or refractory CD19+ B-cell acute lymphoblastic leukemia. MK-1045 dosing occurs once weekly for up to 13 cycles, with two 28-day and eleven 42-day cycles. Blinatumomab is given on days 1, 8, 15, and 22 of each 42-day cycle.
Weekly visits for up to 13 cycles for MK-1045; visits on days 1, 8, 15, and 22 of each 42-day cycle for blinatumomab
Duration - Up to approximately 7 years
Participants are monitored for safety, overall survival, and long-term outcomes up to approximately 7 years after treatment ends.
Regular visits over several years for long-term monitoring
Trial Site Locations
Total: 3 locations
1
Rambam Health Care Campus ( Site 0903)
Haifa, Israel, 3109601
Actively Recruiting
2
Haddasah Medical Center ( Site 0900)
Jerusalem, Israel, 9112001
Actively Recruiting
3
Sheba Medical Center ( Site 0902)
Ramat Gan, Israel, 5265601
Actively Recruiting
Research Team
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How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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