Skip to content

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)

Status
Not yet recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-522267-15-00
Enrollment
36
Registered
2026-06-12
Start date
Unknown
Completion date
Unknown
Last updated
2026-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

​Relapsed/refractory B-cell Acute Lymphoblastic Leukemia​

Brief summary

Part 1: Complete remission (CR) within the first 3 treatment cycles, Part 1: Number of participants with an adverse event (AE), Part 1: Number of participants discontinuing from study therapy due to AE, Part 2: Percentage of participants with CR within the first 3 treatment cycles, Part 2: Overall survival (OS)

Detailed description

Part 1: OS, Part 1: Percentage of participants with minimal residual disease (MRD) negativity within the first 3 treatment cycles, Part 1: Percentage of participants with CR, complete remission with partial hematologic recovery (CRh), or complete remission with incomplete count recovery (CRi) within the first 3 treatment cycles, Part 2: Percentage of participants with MRD negativity within the first 3 treatment cycles, Part 2: Percentage of participants with CR or CRh within the first 3 treatment cycles, Part 2: Percentage of participants with CR, CRh, or CRi within the first 3 treatment cycles, Part 2: Duration of CR, Part 2: Duration of CR/CRh, Part 2: Duration of CR, CRh, or CRi, Part 2: Event free survival (EFS), Part 2: Percentage of participants who undergo allogeneic hematopoietic stem cell transplantation (allo-HSCT), Part 2: Percentage of participants who experienced an adverse event (AE), Part 2: Percentage of participants who discontinued study intervention due to an AE

Interventions

DRUGBLINATUMOMAB
DRUGTOCILIZUMAB

Sponsors

Merck Sharp & Dohme LLC
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
0 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Part 1: Complete remission (CR) within the first 3 treatment cycles, Part 1: Number of participants with an adverse event (AE), Part 1: Number of participants discontinuing from study therapy due to AE, Part 2: Percentage of participants with CR within the first 3 treatment cycles, Part 2: Overall survival (OS)

Secondary

MeasureTime frame
Part 1: OS, Part 1: Percentage of participants with minimal residual disease (MRD) negativity within the first 3 treatment cycles, Part 1: Percentage of participants with CR, complete remission with partial hematologic recovery (CRh), or complete remission with incomplete count recovery (CRi) within the first 3 treatment cycles, Part 2: Percentage of participants with MRD negativity within the first 3 treatment cycles, Part 2: Percentage of participants with CR or CRh within the first 3 treatment cycles, Part 2: Percentage of participants with CR, CRh, or CRi within the first 3 treatment cycles, Part 2: Duration of CR, Part 2: Duration of CR/CRh, Part 2: Duration of CR, CRh, or CRi, Part 2: Event free survival (EFS), Part 2: Percentage of participants who undergo allogeneic hematopoietic stem cell transplantation (allo-HSCT), Part 2: Percentage of participants who experienced an adverse event (AE), Part 2: Percentage of participants who discontinued study intervention due to an AE

Outcome results

None listed

Source: EU CTIS · Data processed: Jun 13, 2026