TINI 2: Total Therapy for Infants With Acute Lymphoblastic Leukemia II
Recruiting now Phase 1/2 NCT05848687
Run by Tanja Andrea Gruber · for Up to 1 · All sexes
What this study is about
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.
Who can join (things the study team will check)
✅ You may be able to join if…
- 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.
🚫 You may not be able to join if…
- Patients with prior therapy, other than therapy specified in inclusion criteria.
- Patients with mature B-cell ALL that do not have a KMT2A rearrangement or patients with acute myelogenous (AML) or T-cell ALL.
- Patients with Down syndrome.
- Inability or unwillingness of legal guardian/representative to give written informed consent
Where this trial is running
- Phoenix Children's Hospital, Phoenix, Arizona, United States
- Arkansas Children's Hospital, Little Rock, Arkansas, United States
- Children's Hospital Los Angeles, Los Angeles, California, United States
- Valley Children's Hospital, Madera, California, United States
- Children's Hospital of Orange County, Orange, California, United States
- Stanford University, Palo Alto, California, United States
- Rady Children's Hospital San Diego, San Diego, California, United States
- Arnold Palmer Hospital for Children, Orlando, Florida, United States
- Children's Hospital of Minnesota, Minneapolis, Minnesota, United States
- Memorial Sloan Kettering Cancer Center, New York, New York, United States
- Novant Health - Hemby Children's Hospital, Charlotte, North Carolina, United States
- Doernbecher Children's Hospital, Portland, Oregon, United States
+ 12 more sites.
Who to contact
Tanja A Gruber, MD, PhD · 650 723 5535 · tagruber@stanford.edu
It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT05848687.
Verify everything on the official ClinicalTrials.gov record. Page updated July 2026.
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