Tests blinatumomab with chemotherapy in infants with acute lymphoblastic leukemia
Tests blinatumomab immunotherapy to clear persistent leukemia in infants under one year.
Plain-language title generated from the registry record
Registry title: TINI 2: Total Therapy for Infants With Acute Lymphoblastic Leukemia II
Key facts
- Where
- Calgary, Edmonton, Hamilton, Montreal, Québec, and Vancouver, CanadaSee the 7 sites
- Phase
- Phase 1/2
Where in Canada
- Alberta Children's HospitalCalgary, CanadaNot yet recruiting
- Stollery Children'S HospitalEdmonton, CanadaNot yet recruiting
- McMaster Children's HospitalHamilton, CanadaNot yet recruiting
- CHU Sainte-JustineMontreal, CanadaNot yet recruiting
- Montreal Children's HospitalMontreal, CanadaNot yet recruiting
- CHU de QuebecQuébec, CanadaNot yet recruiting
- BC Children ' s HospitalVancouver, CanadaNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Tanja Andrea Gruber
- Trial code
- NCT05848687
- Record updated
- 3 June 2026
- Original description
The purpose of this study is to improve upon the TINI study treatment. The study will test the ability of a type of immunotherapy called blinatumomab to clear persistent leukemia. Blinatumomab targets CD19 which is located on the leukemia cells outer membrane.Read full original descriptionShow less
TINI 2: Total Therapy for Infants With Acute Lymphoblastic Leukemia II
The purpose of this study is to improve upon the TINI study treatment. The study will test the ability of a type of immunotherapy called blinatumomab to clear persistent leukemia. Blinatumomab targets CD19 which is located on the leukemia cells outer membrane.
Inclusion: Patient is ≤ 365 days of age at the time of diagnosis; Patient has newly diagnosed CD19 positive acute lymphoblastic leukemia (ALL) or acute undifferentiated leukemia. Subjects with bilineage or biphenotypic acute leukemia are eligible provided they express CD19. Patients with CD19 positive mature B-cell ALL who carry a KMT2A rearrangement are eligible; Limited prior therapy, including hydroxyurea for 72 hours or less, systemic glucocorticoids for one week or less, cytarabine for 72 hours or less, one dose of vincristine, and one dose of intrathecal chemotherapy; Written informed consent following Institutional Review Board, NCI, FDA, and OHRP Guidelines.
Exclusion: Patients with prior therapy, other than therapy specified in inclusion criteria; Patients with Down syndrome; Patients with mature B-cell ALL that do not have a KMT2A rearrangement or patients with acute myelogenous (AML) or T-cell ALL; Inability or unwillingness of legal guardian/representative to give written informed consent.