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NOT YET RECRUITING
NCT07570173
PHASE2/PHASE3

A Clinical Trial of MK-1045 in People With B-cell Acute Lymphoblastic Leukemia (MK-1045-005)

Sponsor: Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

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

Interventions

BIOLOGICAL

MK-1045

Intravenous administration

BIOLOGICAL

Blinatumomab

Intravenous administration

DRUG

Acetaminophen

Oral administration as a premedication

DRUG

Diphenhydramine

Intravenous administration as a premedication

DRUG

Dexamethasone

Intravenous administration as a premedication

DRUG

Tocilizumab

Intravenous administration as a rescue medication

DRUG

Siltuximab

Intravenous administration as a rescue medication

DRUG

Avtozma

Intravenous administration as a rescue medication

DRUG

Tyenne

Intravenous administration as a rescue medication