RecruitingNCT07570173ClinicalTrials.gov record

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

B-cell Acute Lymphoblastic Leukemia

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THE QUICK READ

What this study involves

The registry says this study is recruiting. Individual locations may have different availability.

Study type: Interventional
Phase: Phase 2 / Phase 3
Age range: 12 years - Not specified
Sex eligible: All sexes
Healthy volunteers: Not accepted
Participants: 340 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

Researchers are looking for new ways to treat people with relapsed or refractory B-cell acute lymphoblastic leukemia (R/R B-ALL) that is CD19 positive using a medicine called MK-1045. MK-1045 is an immunotherapy, which is a treatment that helps the immune system fight cancer. This trial will compare MK-1045 to a standard immunotherapy called blinatumomab. The goals of this trial are to learn if more people who receive MK-1045 have no cancer cells in their bone marrow compared to people who receive blinatumomab and if people who receive MK-1045 live longer compared to people who receive blinatumomab.

Read the full description

This study has 2 parts: Part 1 is a dose optimization phase of MK-1045. Part 2 is a randomized phase comparing the efficacy and safety of MK-1045 versus blinatumomab and will use the recommended dose of MK-1045 determined in Part 1

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

Inclusion Criteria:

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)

Exclusion Criteria:

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) or chronic GvHD. NOTE: Participants who have received CNI for GvHD within 4 weeks before the first dose of study intervention are also excluded
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). Refractory to blinatumomab is defined as failure to achieve a response after at least 2 cycles of previous blinatumomab treatment
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

Understand screening

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment: Random assignment
Masking: Single masked

MK-1045 Dose Regimen A

Participants will receive a lower MK-1045 dose once weekly for up to 13 cycles (two 28-day and eleven 42-day cycles). Participants will have the option to change treatment at the end of Part 1.

Biological: MK-1045 · Drug: Acetaminophen · Drug: Diphenhydramine · Drug: Dexamethasone · Drug: Tocilizumab · Drug: Siltuximab · Drug: Avtozma · Drug: Tyenne

MK-1045 Dose Regimen B

Participants will receive a larger MK-1045 dose once weekly for up to 13 cycles (two 28-day and eleven 42-day cycles). Participants will have the option to change treatment at the end of Part 1.

Biological: MK-1045 · Drug: Acetaminophen · Drug: Diphenhydramine · Drug: Dexamethasone · Drug: Tocilizumab · Drug: Siltuximab · Drug: Avtozma · Drug: Tyenne

Blinatumomab

Participants will receive blinatumomab on days 1, 8, 15, and 22 of each 42-day cycle

Biological: Blinatumomab · Drug: Dexamethasone · Drug: Tocilizumab · Drug: Siltuximab · Drug: Avtozma · Drug: Tyenne

MK-1045 BIOLOGICAL

Intravenous administration

Blinatumomab BIOLOGICAL

Intravenous administration

Acetaminophen DRUG

Oral administration as a premedication

Diphenhydramine DRUG

Intravenous administration as a premedication

Dexamethasone DRUG

Intravenous administration as a premedication

Tocilizumab DRUG

Intravenous administration as a rescue medication

Siltuximab DRUG

Intravenous administration as a rescue medication

Avtozma DRUG

Intravenous administration as a rescue medication

Tyenne DRUG

Intravenous administration as a rescue medication

Prepare your questions

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Percentage of Participants with Complete Remission (CR) in Study Part 1 and Part 2

Time frame: 3 treatment cycles (up to approximately 126 days; each cycle is up to 42 days; cycle lengths vary between cycle and arm)

CR is defined as:

No circulating lymphoblasts
Extramedullary disease negative
Trilineage hematopoiesis (TLH) and \<5% leukemic blasts
Absolute neutrophil count (ANC) ≥1000/μL
Platelets ≥100,000/μL
No platelet transfusions in the last 7 days
No administration of short-acting granulocyte colony-stimulating factor (G-CSF) and long-acting G-CSF in the last 3 and 14 days, respectively

Percentage of Participants Who Experience an Adverse Event (AE) in Study Part 1

Time frame: 3 treatment cycles (up to approximately 126 days; each cycle is up to 42 days; cycle lengths vary between cycle and arm)

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants with at least 1 AE will be presented.

Percentage of Participants Who Discontinue Study Intervention Due to an AE in Study Part 1

Time frame: 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

Time frame: Up to approximately 7 years

OS is the time from randomization to death due to any cause.

Secondary measures

Overall survival (OS) in Study Part 1

Time frame: Up to approximately 7 years

OS is the time from randomization to death due to any cause.

Percentage of Participants that achieve Minimal Residual Disease (MRD) in Study Part 1 and Part 2

Time frame: 3 treatment cycles (up to approximately 126 days; each cycle is up to 42 days; cycle lengths vary between cycle and arm)

MRD is defined as no detectable leukemia cells below a threshold of at least 10\^-4.

Percentage of Participants that achieve CR/CR with partial hematologic recovery (CRh)/CR with incomplete count recovery (CRi) in Study Part 1 and Part 2

Time frame: 3 treatment cycles (up to approximately 126 days; each cycle is up to 42 days; cycle lengths vary between cycle and arm)

For participants who demonstrate CR or CRh or CRi, duration of remission is defined as the time from the first documented evidence of CR or CRh or CRi (whichever is earlier) until disease progression, relapse, or death due to any cause, whichever occurs first.

CR is defined as:

No circulating lymphoblasts
Extramedullary disease negative
Trilineage hematopoiesis (TLH) and \<5% leukemic blasts
Absolute neutrophil count (ANC) ≥1000/μL
Platelets ≥100,000/μL
No platelet transfusions in the last 7 days
No administration of short-acting granulocyte colony-stimulating factor (G-CSF) and long-acting G-CSF in the last 3 and 14 days, respectively

CRh is the same as CR but with less stringent requirements for platelet count (≥50,000/μL) and ANC (≥500/μL).

CRi is the same as CR but without recovery of platelet count or without recovery of ANC (platelets \<100,000/μL and ANC ≥1000/μL or platelets ≥100,000/μL and ANC \<1000/μL.

Percentage of Participants with CR or CRh in Study Part 2

Time frame: 3 treatment cycles (up to approximately 126 days; each cycle is up to 42 days; cycle lengths vary between cycle and arm)

The percentage of participants who meet either CR or CRh requirements will be presented.

CR is defined as:

No circulating lymphoblasts
Extramedullary disease negative
Trilineage hematopoiesis (TLH) and \<5% leukemic blasts
Absolute neutrophil count (ANC) ≥1000/μL
Platelets ≥100,000/μL
No platelet transfusions in the last 7 days
No administration of short-acting granulocyte colony-stimulating factor (G-CSF) and long-acting G-CSF in the last 3 and 14 days, respectively

CRh is the same as CR but with less stringent requirements for platelet count (≥50,000/μL) and ANC (≥500/μL).

Duration of CR (DOR-CR) in Study Part 2

Time frame: Up to approximately 7 years

For participants who demonstrate CR, duration of remission is defined as the time from the first documented evidence of CR until disease progression, relapse, or death due to any cause, whichever occurs first.

CR is defined as:

No circulating lymphoblasts
Extramedullary disease negative
Trilineage hematopoiesis (TLH) and \<5% leukemic blasts
Absolute neutrophil count (ANC) ≥1000/μL
Platelets ≥100,000/μL
No platelet transfusions in the last 7 days
No administration of short-acting granulocyte colony-stimulating factor (G-CSF) and long-acting G-CSF in the last 3 and 14 days, respectively

Duration of CR/CRh (DOR-CR/CRh) in Study Part 2

Time frame: Up to approximately 7 years

For participants who demonstrate CR or CRh, duration of remission is defined as the time from the first documented evidence of CR or CRh (whichever is earlier) until disease progression, relapse, or death due to any cause, whichever occurs first.

CR is defined as:

No circulating lymphoblasts
Extramedullary disease negative
Trilineage hematopoiesis (TLH) and \<5% leukemic blasts
Absolute neutrophil count (ANC) ≥1000/μL
Platelets ≥100,000/μL
No platelet transfusions in the last 7 days
No administration of short-acting granulocyte colony-stimulating factor (G-CSF) and long-acting G-CSF in the last 3 and 14 days, respectively

CRh is the same as CR but with less stringent requirements for platelet count (≥50,000/μL) and ANC (≥500/μL).

Duration of CR/CRh/CRi (DOR-CR/CRh/CRi) in Study Part 2

Time frame: Up to approximately 7 years

CR is defined as:

No circulating lymphoblasts
Extramedullary disease negative
Trilineage hematopoiesis (TLH) and \<5% leukemic blasts
Absolute neutrophil count (ANC) ≥1000/μL
Platelets ≥100,000/μL
No platelet transfusions in the last 7 days
No administration of short-acting granulocyte colony-stimulating factor (G-CSF) and long-acting G-CSF in the last 3 and 14 days, respectively

CRh is the same as CR but with less stringent requirements for platelet count (≥50,000/μL) and ANC (≥500/μL).

CRi is the same as CR but without recovery of platelet count or without recovery of ANC (platelets \<100,000/μL and ANC ≥1000/μL or platelets ≥100,000/μL and ANC \<1000/μL.

Event Free Survival (EFS) in Study Part 2

Time frame: Up to approximately 7 years

The time from randomization to the first documented disease progression, relapse, or death due to any cause, whichever occurs first.

Percentage of participants that proceed to allogeneic hematopoietic stem cell transplantation (allo-HSCT) in Study Part 2

Time frame: Up to approximately 7 years

The use of allo-HSCT treatment after randomization.

Percentage of Participants Who Experience an AE in Study Part 2

Time frame: Up to approximately 7 years

Percentage of Participants Who Discontinue Study Intervention Due to an AE in Study Part 2

Time frame: Up to approximately 7 years

No results are flagged as posted.

Review the complete result tables and limitations in the official record.

Open official results ↗

Research locations (30)

The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.

Find a location in this study

30 locations

Princess Margaret Cancer Center ( Site 0102)Toronto, Ontario, CanadaRecruiting

Study CoordinatorCONTACT416-946-4501

What this study involves

About the research

Who may be able to participate?

Treatment, groups and participation

What researchers are measuring

Primary measures

Secondary measures

Research locations (30)

Study team and timeline

Official study contacts

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