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
Sex
ALL
Min age
12 Years
Max age
—
Healthy volunteers
No
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)
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.
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