RecruitingPhase 2Phase 3NCT07570173

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

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)


Sponsor

Merck Sharp & Dohme LLC

Enrollment

340 participants

Start Date

May 18, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 12 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Acetaminophen, a drug called Avtozma, and others for people with b-cell acute lymphoblastic leukemia. The study is currently recruiting participants at 3 locations. People eligible for this study include aged 12 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALMK-1045

Intravenous administration

BIOLOGICALBlinatumomab

Intravenous administration

DRUGAcetaminophen

Oral administration as a premedication

DRUGDiphenhydramine

Intravenous administration as a premedication

DRUGDexamethasone

Intravenous administration as a premedication

DRUGTocilizumab

Intravenous administration as a rescue medication

DRUGSiltuximab

Intravenous administration as a rescue medication

DRUGAvtozma

Intravenous administration as a rescue medication

DRUGTyenne

Intravenous administration as a rescue medication


Locations(11)

Rigshospitalet ( Site 0802)

Copenhagen, Capital Region, Denmark

Aarhus Universitetshospital. Hæmatologisk afdeling ( Site 0804)

Aarhus Nord, Central Jutland, Denmark

Odense Universitetshospital ( Site 0801)

Odense, Region Syddanmark, Denmark

Rambam Health Care Campus ( Site 0903)

Haifa, Israel

Haddasah Medical Center ( Site 0900)

Jerusalem, Israel

Sheba Medical Center ( Site 0902)

Ramat Gan, Israel

Sourasky Medical Center. ( Site 0904)

Tel Aviv, Israel

Tokyo Metropolitan Komagome Hospital ( Site 2106)

Bunkyo, Tokyo, Japan

Radboud UMC ( Site 2003)

Geert Grooteplein-Zuid 8, Gelderland, Netherlands

HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID ( Site 3009)

Madrid, Spain

Hospital Universitario de Salamanca ( Site 3002)

Salamanca, Spain

View Full Details on ClinicalTrials.gov

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NCT07570173


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