MK-1045 versus blinatumomab for relapsed or refractory CD19-positive B-cell acute lymphoblastic leukemia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The trial tests MK-1045, a CD19-directed immunotherapy, in people with relapsed or refractory B-cell acute lymphoblastic leukemia (R/R B-ALL). It has two parts: Part 1 determines the recommended dose of MK-1045 and Part 2 randomly assigns participants to receive either MK-1045 or blinatumomab using that dose. The main outcomes include clearance of leukemic cells from the bone marrow and overall survival, with safety closely monitored. The study enrolls patients with CD19-positive, Philadelphia-negative disease who meet recovery and other eligibility criteria.

Why it matters

Who can join: the full rules

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

Where it's running

• Princess Margaret Cancer Center ( Site 0102)
  Toronto, Ontario, Canada Recruiting
• Rigshospitalet ( Site 0802)
  Copenhagen, Capital Region, Denmark Recruiting
• Aarhus Universitetshospital. Hæmatologisk afdeling ( Site 0804)
  Aarhus Nord, Central Jutland, Denmark Recruiting
• Odense Universitetshospital ( Site 0801)
  Odense C, Region Syddanmark, Denmark Recruiting
• CHU Bordeaux Haut-Leveque ( Site 4103)
  Pessac, Gironde, France Recruiting
• Hopital Saint-Louis ( Site 4100)
  Paris, Île-de-France Region, France Recruiting

Study contacts

• Study coordinator: Toll Free Number
• Email: Trialsites@msd.com
• Phone: 1-888-577-8839

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Using blinatumomab with autologous stem cell transplant for B-cell leukemia treatment

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  Recruiting Phase 1 The First Affiliated Hospital of Soochow University · Suzhou, Jiangsu · NCT06507514

• Using decitabine, venetoclax, and blinatumomab for maintenance therapy in B-ALL patients after stem cell transplant

  This study is testing a combination of three medications to see if they can help people with B-cell acute lymphoblastic leukemia stay in remission after a stem cell transplant.

  Recruiting Phase 2 The First Affiliated Hospital of Soochow University · Suzhou, Jiangsu · NCT06393985

• Blinatumomab treatment after specific stem cell transplant for high-risk leukemia

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• Combination treatment for BCR-ABL positive B-cell leukemia and chronic myeloid leukemia

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  Recruiting at 4 sites Phase 1 Dana-Farber Cancer Institute · Chicago, Illinois and 3 other locations · NCT03595917

• CD19 and CD22 in vivo CAR-T therapy for relapsed/refractory B-ALL

  This study tests a one-of-a-kind in vivo CAR-T treatment that targets CD19 first and then CD22 in adults with relapsed or refractory B-ALL to see if it is safe and possibly effective.

  Recruiting Phase 1 Chinese PLA General Hospital · Beijing, Beijing Municipality · NCT07927816

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.