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

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 blinatu

Trial Details

NCT ID
NCT07570173
Phase
PHASE2 / PHASE3
Sponsor
Merck Sharp & Dohme LLC
Status
RECRUITING
Cancer Type
Leukemia
Interventions
  • MK-1045
  • Blinatumomab
  • Acetaminophen
  • Diphenhydramine
  • Dexamethasone
  • Tocilizumab
Locations (sample)
  • Toronto, Ontario, Canada|43.70643,-79.39864
  • Copenhagen, Capital Region, Denmark|55.67594,12.56553
  • Aarhus Nord, Central Jutland, Denmark
  • Odense C, Region Syddanmark, Denmark|55.40841,10.39538
  • Pessac, Gironde, France|44.80565,-0.6324

Key Eligibility Criteria

  • 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

For full eligibility, visit ClinicalTrials.gov.

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