Phase 23 Study Comparing MK-1045 to Blinatumomab in Patients 12 and Older With Relapsed or Refractory CD19 B-cell Acute Lymphoblastic Leukemia

What this Trial Is About

Researchers are investigating new treatments for people aged 12 and older with relapsed or refractory CD19-positive B-cell acute lymphoblastic leukemia B-ALL. This trial compares an experimental immunotherapy called MK-1045 to a standard immunotherapy called blinatumomab. The study aims to find out if MK-1045 leads to more patients having no cancer cells in their bone marrow and if it can help patients live longer than with blinatumomab. The study has two parts. Part 1 focuses on finding the best dose of MK-1045, with participants receiving either a lower or higher dose once a week for up to 13 cycles, each cycle lasting between 28 and 42 days. Participants receiving blinatumomab get it on days 1, 8, 15, and 22 of each 42-day cycle. At the end of Part 1, participants may choose to change treatments. Part 2 compares the effectiveness and safety of MK-1045 at the recommended dose versus blinatumomab. Participants will be closely monitored through bone marrow tests and other assessments to determine their response to treatment, including remission status and survival over up to seven years. Researchers will track side effects, treatment discontinuation, and long-term outcomes. The study includes regular visits for treatment and monitoring throughout the cycles and follow-up periods.

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