臨床研究等提出・公開システム

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)

MK-1045 Versus Blinatumomab in CD19+ B-Cell Acute Lymphoblastic Leukemia

Fujita Tomoko

MSD K.K.

KITANOMARU SQUARE,1-13-12,Kudan-kita,Chiyoda-ku,Tokyo 102-8667,Japan

msdjrct@msd.com

MSDJRCT inquiry mailbox

MSD K.K.

KITANOMARU SQUARE,1-13-12,Kudan-kita,Chiyoda-ku,Tokyo 102-8667,Japan

+81-3-6272-1957

msdjrct@msd.com

Pending

June. 19, 2026

Interventional

randomized controlled trial

open(masking not used)

active control

parallel assignment

treatment purpose

- 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.
- Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART).

- Has Burkitt's leukemia.
- History or presence of clinically relevant central nervous system (CNS) diseases such as epilepsy, hemorrhagic/ischemic stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, and psychosis.
- Has active acute graft versus host disease (GvHD), Grade 2 to 4 according to the Glucksberg criteria or active chronic GvHD requiring systemic treatment.
- History of serious cardiovascular and cerebrovascular diseases.
- HIV-infection with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease.
- Received prior treatment with blinatumomab within 12 weeks for Part 1 and 24 weeks for Part 2 before the first dose of study intervention (individuals known to be refractory or intolerant to blinatumomab are to be excluded).
- Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study intervention.
- Known additional malignancy that is progressing or has required active treatment within the past 2 years.
- Isolated extramedullary disease (EMD).
- Active autoimmune disease unrelated to ALL that has required systemic treatment in the past 2 years or history of autoimmune disease with potential CNS involvement.
- Active infection requiring systemic therapy.
- Has not adequately recovered from major surgery or have ongoing surgical complications.

Both

Relapsed or Refractory CD19+ B-Cell Acute Lymphoblastic Leukemia (B-ALL)

Each participant will receive the assigned study intervention for up to approximately 74 weeks (MK-1045) or 78 weeks (blinatumomab).

Part 1
-CR within the first 3 treatment cycles
-AEs
-Discontinuation of study intervention due to an AE
Part 2
-CR within the first 3 treatment cycles
-OS: the time from randomization to death
due to any cause

Part 1
-OS: the time from randomization to death due to any cause
-MRD negativity within the first 3 treatment cycles
-CR or CRh or CRi within the first 3 treatment cycles

Part 2
-MRD negativity within the first 3 treatment cycles
-CR or CRh within the first 3 treatment cycles
-CR or CRh or CRi within the first 3 treatment cycles
-Duration of CR
-Duration of CR/CRh
-Duration of CR/CRh/CRi
-EFS
-allo-HSCT
-AEs
-Discontinuation of study intervention due to an AE

+81-3-3823-2101

Yes

https://engagezone.msd.com/

United States of America/Canada/Australia/New Zealand/China/Brazil/Chile/Mexico/Denmark/France/Greece/Italy/Netherlands/Spain/Sweden/Israel