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| ID | Type | Description | Link |
|---|---|---|---|
| MK-1045-005 | Other Identifier | MSD | |
| 2025-522267-15-00 | Registry Identifier | EU CT | |
| U1111-1322-4387 | Registry Identifier | UTN |
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MK-1045 Dose Regimen A | Experimental | 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. |
|
| MK-1045 Dose Regimen B | Experimental | 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. |
|
| Blinatumomab | Active Comparator | Participants will receive blinatumomab on days 1, 8, 15, and 22 of each 42-day cycle |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MK-1045 | Biological | Intravenous administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants with Complete Remission (CR) in Study Part 1 and Part 2 | CR is defined as:
| 3 treatment cycles (up to approximately 126 days; each cycle is up to 42 days; cycle lengths vary between cycle and arm) |
| Percentage of Participants Who Experience an Adverse Event (AE) in Study Part 1 | 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. | 3 treatment cycles (up to approximately 126 days; each cycle is up to 42 days; cycle lengths vary between cycle and arm) |
| Percentage of Participants Who Discontinue Study Intervention Due to an AE in Study Part 1 | 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 who discontinue study intervention due to an AE will be presented. | 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 | OS is the time from randomization to death due to any cause. | Up to approximately 7 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival (OS) in Study Part 1 | OS is the time from randomization to death due to any cause. | Up to approximately 7 years |
| Percentage of Participants that achieve Minimal Residual Disease (MRD) in Study Part 1 and Part 2 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Toll Free Number | Contact | 1-888-577-8839 | Trialsites@msd.com |
| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aarhus Universitetshospital. Hæmatologisk afdeling ( Site 0804) | Recruiting | Aarhus Nord | Central Jutland | 8200 | Denmark |
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| Label | URL |
|---|---|
| Merck Clinical Trials Information | View source |
| Plain Language Summary | View source |
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Review of all disease response assessments in the Phase 3 component will be performed by an independent Clinical Adjudication Committee.
Reviewers will be blinded to treatment allocation and investigator assessment.
| Blinatumomab | Biological | Intravenous administration |
|
| Acetaminophen | Drug | Oral administration as a premedication |
|
| Diphenhydramine | Drug | Intravenous administration as a premedication |
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| Dexamethasone | Drug | Intravenous administration as a premedication |
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| Tocilizumab | Drug | Intravenous administration as a rescue medication |
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| Siltuximab | Drug | Intravenous administration as a rescue medication |
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| Avtozma | Drug | Intravenous administration as a rescue medication |
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| Tyenne | Drug | Intravenous administration as a rescue medication |
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MRD is defined as no detectable leukemia cells below a threshold of at least 10^-4.
| 3 treatment cycles (up to approximately 126 days; each cycle is up to 42 days; cycle lengths vary between cycle and arm) |
| 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 | 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:
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. | 3 treatment cycles (up to approximately 126 days; each cycle is up to 42 days; cycle lengths vary between cycle and arm) |
| Percentage of Participants with CR or CRh in Study Part 2 | The percentage of participants who meet either CR or CRh requirements will be presented. CR is defined as:
CRh is the same as CR but with less stringent requirements for platelet count (≥50,000/μL) and ANC (≥500/μL). | 3 treatment cycles (up to approximately 126 days; each cycle is up to 42 days; cycle lengths vary between cycle and arm) |
| Duration of CR (DOR-CR) in Study Part 2 | 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:
| Up to approximately 7 years |
| Duration of CR/CRh (DOR-CR/CRh) in Study Part 2 | 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:
CRh is the same as CR but with less stringent requirements for platelet count (≥50,000/μL) and ANC (≥500/μL). | Up to approximately 7 years |
| Duration of CR/CRh/CRi (DOR-CR/CRh/CRi) in Study Part 2 | 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:
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. | Up to approximately 7 years |
| Event Free Survival (EFS) in Study Part 2 | The time from randomization to the first documented disease progression, relapse, or death due to any cause, whichever occurs first. | Up to approximately 7 years |
| Percentage of participants that proceed to allogeneic hematopoietic stem cell transplantation (allo-HSCT) in Study Part 2 | The use of allo-HSCT treatment after randomization. | Up to approximately 7 years |
| Percentage of Participants Who Experience an AE in Study Part 2 | 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. | Up to approximately 7 years |
| Percentage of Participants Who Discontinue Study Intervention Due to an AE in Study Part 2 | 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 who discontinue study intervention due to an AE will be presented. | Up to approximately 7 years |
| Odense Universitetshospital ( Site 0801) | Recruiting | Odense | Region Syddanmark | 5000 | Denmark |
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| Rambam Health Care Campus ( Site 0903) | Recruiting | Haifa | 3109601 | Israel |
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| Haddasah Medical Center ( Site 0900) | Recruiting | Jerusalem | 9112001 | Israel |
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| Sheba Medical Center ( Site 0902) | Recruiting | Ramat Gan | 5265601 | Israel |
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| Tokyo Metropolitan Komagome Hospital ( Site 2106) | Recruiting | Bunkyo | Tokyo | 113-8677 | Japan |
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| Radboud UMC ( Site 2003) | Recruiting | Geert Grooteplein-Zuid 8 | Gelderland | 6500 HB | Netherlands |
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| HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID ( Site 3009) | Recruiting | Madrid | 28233 | Spain |
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| Hospital Universitario de Salamanca ( Site 3002) | Recruiting | Salamanca | 37007 | Spain |
|
| ID | Term |
|---|---|
| D002051 | Burkitt Lymphoma |
| ID | Term |
|---|---|
| D020031 | Epstein-Barr Virus Infections |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D014412 | Tumor Virus Infections |
| D016393 | Lymphoma, B-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C510808 | blinatumomab |
| D000082 | Acetaminophen |
| D004155 | Diphenhydramine |
| D003907 | Dexamethasone |
| C502936 | tocilizumab |
| C504234 | siltuximab |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D005021 | Ethylamines |
| D001559 | Benzhydryl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
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