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

NCT07570173Phase 2/3Recruiting

Lead sponsor
Merck Sharp & Dohme LLC (Industry)
Enrollment
340 (estimated)
Start date
18 May 2026
Primary completion
18 Oct 2033 (estimated)
Study completion
18 Oct 2033
Last update posted
30 Oct 2026

Design

Study type
Interventional
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel
Masking
Single
Arms
3

Interventions

  • MK-1045 Biological
  • Blinatumomab Biological
  • Acetaminophen Drug
  • Diphenhydramine Drug
  • Dexamethasone Drug
  • Tocilizumab Drug
  • Siltuximab Drug
  • Avtozma Drug
  • Tyenne Drug

Conditions and primary outcome

  • B-cell Acute Lymphoblastic Leukemia

Primary outcome

Percentage of Participants with Complete Remission (CR) in Study Part 1 and Part 2 (3 treatment cycles (up to approximately 126 days; each cycle is up to 42 days; cycle lengths vary between cycle and arm)); Percentage of Participants Who Experience an Adverse Event (AE) in Study Part 1 (3 treatment cycles (up to approximately 126 days; each cycle is up to 42 days; cycle lengths vary between cycle and arm)); Percentage of Participants Who Discontinue Study Intervention Due to an AE in Study Part 1 (3 treatment cycles (up to approximately 126 days; each cycle is up to 42 days; cycle lengths vary between cycle and arm)); Overall Survival (OS) in Study Part 2 (Up to approximately 7 years)

Posted results on ClinicalTrials.gov

Results posted on ClinicalTrials.gov: No

Results from company and journal sources

No editor-confirmed results are on record for this study.

Publications

No PubMed citation lists NCT07570173.

CT-VCA trial quality

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Data integrity

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Drugs on HealthTrade

Source

Source: ClinicalTrials.gov, U.S. National Library of Medicine. Listing a study does not mean NLM has evaluated it.

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