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| Diagnosis | B Cell Precursor Acute Lymphoblastic Leukemia | Study Status | Open |
| Phase | I/II |
| Age | 12 Years and older | Randomisation | NO |
| Line of treatment | Disease relapse or progression |
| Routes of Treatment Administration | Blinatumomab administered as a subcutaneous (SC) injection
Other Names: AMG 103 |
| Last Posted Update | 2026-03-13 |
| ClinicalTrials.gov # | NCT04521231 |
International Sponsor
AmgenPrincipal Investigators for Canadian Sites
The Hospital for Sick Children (SickKids) - Dr. Jim Whitlock
Centres
Study Description
This study is evaluating a medication called blinatumomab that is given as an injection under the skin to treat B-cell acute lymphoblastic leukemia (B-ALL) that has come back after treatment or has not responded to previous therapy. The first part of the study will focus on finding the safest and most appropriate dose, while the second part will look more closely at how well the treatment works and how safe it is in participants aged 12 years and older. The study will include people whose leukemia has returned, has not responded to treatment, or who still have a very small number of leukemia cells remaining after treatment. Researchers will also study how the medication moves through and is processed by the body.
Inclusion Criteria
- Participants must be 12 Years and older. Additional age restrictions may apply for specific arms of this study.
- Must have a diagnosis of B-precursor Acute Lymphoblastic Leukemia (ALL) that has come back after treatment or has not responded to previous therapy.
- Must meet bone marrow blast and function requirements
- Must be up and about at least 50% of waking hours
Other inclusion and exclusion criteria may apply and will be discussed with you by the study team.
