Clinical Trials in Italy / NCT07570173
Recruiting
Phase 2/3
A Clinical Trial of MK-1045 in People With B-cell Acute Lymphoblastic Leukemia (MK-1045-005)
NCT07570173 · tracked via the Priya Life Science Italy tracker
Condition(s) studied
B-cell Acute Lymphoblastic Leukemia
Investigational drug(s) / intervention(s)
MK-1045 →Blinatumomab →Acetaminophen →Diphenhydramine →Dexamethasone →Tocilizumab →Siltuximab →Avtozma →Tyenne →
MK-1045: Intravenous administration
Blinatumomab: Intravenous administration
Acetaminophen: Oral administration as a premedication
Diphenhydramine: Intravenous administration as a premedication
Dexamethasone: Intravenous administration as a premedication
Tocilizumab: Intravenous administration as a rescue medication
Siltuximab: Intravenous administration as a rescue medication
Avtozma: Intravenous administration as a rescue medication
Tyenne: Intravenous administration as a rescue medication
Study summary
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.
Eligibility
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
Primary outcome measure(s)
- Percentage of Participants with Complete Remission (CR) in Study Part 1 and Part 2 — 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 — 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 — 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 who discontinue study intervention due to an AE will be presented. - Overall Survival (OS) in Study Part 2 — Up to approximately 7 years
OS is the time from randomization to death due to any cause.
Trial sites (23)
| Facility | City | Region | Status |
|---|---|---|---|
| Rigshospitalet ( Site 0802) | Copenhagen | Capital Region | Recruiting |
| Aarhus Universitetshospital. Hæmatologisk afdeling ( Site 0804) | Aarhus Nord | Central Jutland | Recruiting |
| Odense Universitetshospital ( Site 0801) | Odense C | Region Syddanmark | Recruiting |
| Evangelismos General Hospital of Athens ( Site 5100) | Athens | Attica | Recruiting |
| General Hospital of Athens "Laiko" ( Site 5101) | Athens | Attica | Recruiting |
| General Hospital of Athens "Laiko" ( Site 5104) | Athens | Attica | Recruiting |
| University General Hospital ''Attikon'' - General Hospital of West Attica "H AGIA VARVARA" ( Site 5102) | Chaïdári | Attica | Recruiting |
| University Hospital of Ioannina ( Site 5103) | Ioannina | Greece | Recruiting |
| Rambam Health Care Campus ( Site 0903) | Haifa | Israel | Recruiting |
| Haddasah Medical Center ( Site 0900) | Jerusalem | Israel | Recruiting |
| Sheba Medical Center ( Site 0902) | Ramat Gan | Israel | Recruiting |
| Sourasky Medical Center. ( Site 0904) | Tel Aviv | Israel | Recruiting |
| Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII ( Site 1002) | Bergamo | Lombardy | Recruiting |
| Policlinico Universitario Agostino Gemelli ( Site 1003) | Rome | Roma | Recruiting |
| Tokyo Metropolitan Komagome Hospital ( Site 2106) | Bunkyo | Tokyo | Recruiting |
| Toranomon Hospital ( Site 2101) | Minato | Tokyo | Recruiting |
| Radboud UMC ( Site 2003) | Geert Grooteplein-Zuid 8 | Gelderland | Recruiting |
| Amsterdam UMC ( Site 2001) | Amsterdam | North Holland | Recruiting |
| Erasmus Medisch Centrum ( Site 2000) | Rotterdam | South Holland | Recruiting |
| Institut Català d'Oncologia (ICO) - Badalona ( Site 3001) | Badalona | Barcelona | Recruiting |
| HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID ( Site 3009) | Madrid | Spain | Recruiting |
| Hospital Universitario de Salamanca ( Site 3002) | Salamanca | Spain | Recruiting |
| Karolinska Universitetssjukhuset ( Site 4002) | Stockholm | Stockholm County | Recruiting |
More Merck Sharp & Dohme LLC trials in Italy
Other trials for the same condition
Study of Efficacy and Safety of Tisagenlecleucel in HR B-ALL EOC MRD Positive Patients
Active, not recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07570173 on ClinicalTrials.gov ↗ ← All trials in Italy