TINI 2: Total Therapy for Infants With Acute Lymphoblastic Leukemia II
Recruiting now · Phase 1/Phase 2
Conditions studied: Lymphoblastic Leukemia
In brief
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.
Key facts
- Study ID
- NCT05848687
- Run by
- Tanja Andrea Gruber
- People needed
- 90
- Starts
- 2023-11-03
- Expected to finish
- 2033-12-01
- Last updated by the study team
- 2026-06-03
Who can join
Age: any, up to 1. Sex: any. Healthy volunteers: not accepted.
You may qualify 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 qualify 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 it is running
- Phoenix Children's Hospital — Phoenix, Arizona, United States (enrolling)
- Arkansas Children's Hospital — Little Rock, Arkansas, United States (enrolling)
- Children's Hospital Los Angeles — Los Angeles, California, United States (enrolling)
- Valley Children's Hospital — Madera, California, United States (enrolling)
- Children's Hospital of Orange County — Orange, California, United States (enrolling)
- Stanford University — Palo Alto, California, United States (enrolling)
- Arnold Palmer Hospital for Children — Orlando, Florida, United States (enrolling)
- Children's Hospital of Minnesota — Minneapolis, Minnesota, United States (enrolling)
- Memorial Sloan Kettering Cancer Center — New York, New York, United States (enrolling)
- Doernbecher Children's Hospital — Portland, Oregon, United States (enrolling)
- Penn State Milton S Hershey Medical Center — Hershey, Pennsylvania, United States (enrolling)
- MD Anderson — Houston, Texas, United States (enrolling)
- University of Texas Health Science Center San Antonio — San Antonio, Texas, United States (enrolling)
- University of Utah Huntsman Cancer Institute — Salt Lake City, Utah, United States (enrolling)
- Children's Hospital of The King's Daughters — Norfolk, Virginia, United States (enrolling)
- Rady Children's Hospital San Diego — San Diego, California, United States
- Montreal Children's Hospital — Montreal, Quebec, Canada
- Chu De Quebec — Québec, Quebec, Canada
- Alberta Children's Hospital — Calgary, Alberta, Canada
- Novant Health - Hemby Children's Hospital — Charlotte, North Carolina, United States
- Stollery Children's Hospital — Edmonton, Alberta, Canada
- BC Children's Hospital — Vancouver, British Columbia, Canada
- McMaster Children's Hospital — Hamilton, Ontario, Canada
- CHU Sainte-Justine — Montreal, Quebec, Canada
Full record on ClinicalTrials.gov
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