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

StatusRecruiting
PhasePhase 2/3
Started

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Record History

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  1. Trial sites expanded: 23 → 27 locations
  2. Study sites: 23 to 25
  3. Study sites: 22 to 23
  4. Lead sponsor: Merck Sharp & Dohme LLC to Merck Sharp & Dohme LLC
    • Study sites: 21 to 22
    • Eligibility criteria expanded, about 17 words
    • Secondary endpoints: details revised at 8 of 11 entries
  5. Re-verified, no change to tracked fieldsv14
Show 4 earlier versionsHide 4 earlier versions
  1. Study sites: 20 to 21v13
  2. Study sites: 19 to 20v12
  3. Study sites: 18 to 19v11
  4. Re-verified, no change to tracked fieldsv10
  1. Trial sites expanded: 12 → 18 locationsv9
  2. Study sites: 11 to 12v8
  3. Study sites: 9 to 11v7
  4. Trial sites expanded: 5 → 9 locationsv6
  5. Study sites: 3 to 5v5
  6. Primary completion pushed from Feb 10, 2029 to Oct 18, 2033
    • Study completion pushed from Oct 2, 2029 to Oct 18, 2033
    • Eligibility criteria expanded, about 28 words
    • Secondary endpoints: details revised at 8 of 11 entries
    v4
  7. Study sites: 1 to 3
    • Start date changed from estimate of May 22, 2026 to May 18, 2026
    v3
  8. Recruitment opened
    • Study sites: 0 to 1
    • Start date: May 8, 2026 to May 22, 2026
    v2
  9. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07570173
Lead Sponsor Merck Sharp & Dohme LLC
Conditions
(from sponsor)		 B-cell Acute Lymphoblastic Leukemia
Related terms Burkitt Lymphoma
Enrollment 340 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov