Study of MK-1045, Blinatumomab and Tocilizumab in Patients with Relapsed or Refractory B‑Cell Acute Lymphoblastic Leukemia

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What is this study about?

The trial focuses on adults with relapsed or refractory CD19+ B-cell acute lymphoblastic leukemia, a type of blood cancer where abnormal white blood cells grow quickly. “Relapsed” means the disease has returned after previous treatment, and “refractory” means it has not responded to standard therapy. The study will test an investigational medicine called MK-1045, given through a vein (intravenous infusion), and compare it with an existing therapy named blinatumomab, also given by intravenous infusion.

The purpose of the study is to evaluate whether MK-1045 can achieve a higher rate of complete remission and improve overall survival compared with blinatumomab. The trial is divided into two parts: an early phase that determines the best dose and safety of MK-1045, followed by a later phase that directly compares the two medicines.

Participants will receive a series of infusion visits over several weeks, with regular check‑ups to monitor response and any side effects. Researchers will look for signs that the disease is no longer detectable, known as minimal residual disease negativity, and will track how long any remission lasts. Some participants may later undergo a procedure called allogeneic hematopoietic stem cell transplantation, where stem cells from a donor are used to rebuild healthy blood cells. Safety will be assessed by recording any adverse events and whether participants need to stop treatment because of them.

1 randomization

after enrollment, the study assigns the participant to receive either mk-1045 (test drug) or blinatumomab (comparator). the assignment is done by the study system and is not chosen by the participant.

2 first treatment cycle

the assigned medication is given by intravenous infusion, which means the drug is delivered directly into a vein through a needle.

if the participant receives mk-1045, the infusion is a solution for infusion prepared according to the study protocol. the exact volume is expressed as a percentage (v/v) and is defined by the protocol.

if the participant receives blinatumomab, the dose is 28 µg (micrograms) per infusion, administered intravenously as described in the protocol.

the infusion is performed at the study site on the scheduled day for the first cycle.

3 monitoring during cycle 1

the participant undergoes laboratory tests and clinical checks to evaluate safety and any side effects (adverse events).

any symptoms or problems are recorded and reported to the study team.

the participant may receive additional supportive care if needed, as allowed by the protocol.

4 second treatment cycle

the participant returns for the next intravenous infusion of the same medication, following the same dose and method as in cycle 1.

the timing of the second cycle follows the schedule defined by the study, typically after a set interval from the first infusion.

5 monitoring during cycle 2

repeat laboratory tests and clinical assessments are performed to check for safety, side effects, and early signs of response.

the participant continues to report any new or worsening symptoms.

6 third treatment cycle

a third intravenous infusion of the assigned drug is given, using the same dose and administration method as in the previous cycles.

7 monitoring during cycle 3

laboratory and clinical evaluations are repeated to assess safety and to determine whether the participant has achieved complete remission (the disappearance of disease signs) within the first three cycles.

any adverse events are documented.

8 response assessment

after the three cycles, the study evaluates the primary outcome of complete remission and records the number of participants with adverse events or who discontinue treatment because of adverse events.

the assessment follows the definitions set out in the study protocol.

9 follow‑up

participants continue to be followed for overall survival and any long‑term side effects as defined by the study.

regular check‑ups and laboratory tests are performed according to the schedule in the protocol.

Who Can Join the Study?

  • Be at least 12 years old.
  • Have a confirmed diagnosis of relapsed/refractory B‑precursor acute lymphoblastic leukemia (ALL) with at least 5% of immature white blood cells (called lymphoblasts) found in the bone marrow. Relapsed/refractory means the disease has come back or does not respond to previous treatments.
  • Show CD19‑positive disease, which is proven by a lab test called flow cytometry or by immunohistochemistry. These tests look for a specific protein (CD19) on the cancer cells.
  • Have a Philadelphia‑negative disease, meaning tests show the cancer cells do not have the Philadelphia chromosome (a genetic change that can affect treatment).
  • Any side effects (adverse events) from earlier cancer medicines must have improved to mild (grade 1 or lower) or returned to the level they were before treatment.

Who Cannot Join the Study?

  • Burkitt’s leukemia: a fast‑growing type of blood cancer that is different from the leukemia being studied.
  • Central nervous system (CNS) diseases such as epilepsy (recurrent seizures), hemorrhagic or ischemic stroke (bleeding or blockage in the brain’s blood vessels), severe brain injuries, dementia (memory loss and thinking problems), Parkinson’s disease (tremor and movement difficulty), cerebellar disease (problems with balance and coordination), organic brain syndrome (general brain dysfunction), or psychosis (loss of touch with reality). These conditions affect the brain or nerves and would keep a person from joining.
  • Active acute or chronic graft versus host disease (GvHD): a condition that can occur after a stem‑cell or bone‑marrow transplant where the new immune cells attack the patient’s own tissues. Also, anyone who has taken a CNI (a medication that suppresses the immune system) for GvHD within 4 weeks before the study start cannot join.
  • Serious cardiovascular or cerebrovascular diseases: major problems with the heart (cardiovascular) or with the blood vessels in the brain (cerebrovascular), such as heart attacks or major strokes.
  • Not fully recovered from a major surgery or still having complications from that surgery, such as ongoing pain, infection, or healing problems.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Evangelismos S.A. Athens Greece
University General Hospital Of Ioannina Ioannina Greece
Odense University Hospital Odense Denmark
Karolinska University Hospital Solna Sweden
Stichting Radboud University Medical Center Nijmegen The Netherlands
IRCCS Ospedale Policlinico San Martino Genoa Italy
Hospital Universitario Quironsalud Madrid Pozuelo De Alarcon Spain
Prinses Maxima Centrum voor Kinderoncologie B.V. Utrecht The Netherlands
Aalborg University Hospital Aalborg Denmark
Region Midtjylland Aarhus Denmark
Rigshospitalet Copenhagen Denmark
Hospital General Universitario Gregorio Maranon Madrid Spain
Azienda Ospedaliera Ordine Mauriziano Di Torino Turin Italy
University General Hospital Attikon General Hospital Of West Attica H Agia Varvara Chaidari Greece
Lucvs Guvuwam Hcpxablh Os Abhlln Athens Greece
Aughdqanc Ulz Amsterdam The Netherlands
Ayyarooqxh Pntizrmu Hzbpitwh Dv Pmmvt Paris France
Eabydxc Ugymalakahcf Mshzszn Czubyjl Rhhlugapx (ymouach Mgb Rotterdam The Netherlands
Apqwpae Ultrj Srtbvbkwp Lxdell Du Btkqxdh Bologna Italy
Apwfiab Ovcemtyvzaz Pnvl Ghtmftbc Xsagq Bergamo Italy
Ibhzdfyc Cpdqxh Dcdbazpdogufvqotd L'hospitalet De Llobregat Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Denmark Denmark
Not yet recruiting
17.06.2026
France France
Not yet recruiting
17.06.2026
Greece Greece
Not yet recruiting
17.06.2026
Italy Italy
Not yet recruiting
17.06.2026
Spain Spain
Not yet recruiting
17.06.2026
Sweden Sweden
Not yet recruiting
17.06.2026
The Netherlands The Netherlands
Not yet recruiting
17.06.2026

Trial locations

Investigated drugs:

MK-1045 is an experimental medicine being studied for the first time in this trial. It is given through an IV infusion as a liquid solution. The study is looking at the best dose that can safely produce a complete remission of the cancer and at how well patients tolerate the drug. Researchers will compare the results with those from the standard treatment to see if MK-1045 works better or has fewer side effects.

Blinatumomab is an approved medication that is used as a comparison (or control) in this study. It is also administered by IV infusion. In the trial, blinatumomab serves as the standard treatment against which the new drug MK-1045 is measured. The study will evaluate how many patients achieve complete remission and how long they survive when treated with blinatumomab versus the experimental drug.

Tocilizumab is a background therapy that may be given to help manage side effects, especially inflammation that can occur with immune‑based treatments. It is delivered by IV infusion. In this trial, tocilizumab is not the main drug being tested, but it is used to support patients and reduce complications while they receive either MK-1045 or blinatumomab.

Relapsed/refractory B-cell Acute Lymphoblastic Leukemia – Relapsed/refractory B-cell Acute Lymphoblastic Leukemia is a blood cancer that starts in immature B‑cell precursors in the bone marrow. It is called “relapsed” when the disease returns after an initial period of remission, and “refractory” when it does not respond to standard treatments. The cancer cells multiply quickly, crowding out normal blood cells and leading to low counts of red cells, white cells, and platelets. As the disease progresses, the number of leukemia cells in the blood and bone marrow continues to increase, causing symptoms such as fatigue, easy bruising, and infections. The condition can spread to other parts of the body, including the central nervous system, as the abnormal cells travel through the bloodstream.

Trial ID:
2025-522267-15-00
Protocol code:
MK-1045-005
NCT ID:
NCT07570173
Trial Phase:
Therapeutic use (Phase IV)

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