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.

Trial Details

NCT ID

NCT05848687

Phase

PHASE1 / PHASE2

Sponsor

Tanja Andrea Gruber

Status

RECRUITING

Cancer Type

Acute Lymphoblastic (ALL) Leukemia

Interventions

Dexamethasone
Mitoxantrone
PEG asparaginase
Bortezomib
Vorinostat
Mercaptopurine

Locations (sample)

Phoenix, Arizona, United States|33.44838,-112.07404
Little Rock, Arkansas, United States|34.74648,-92.28959
Los Angeles, California, United States|34.05223,-118.24368
Madera, California, United States|36.96134,-120.06072
Orange, California, United States|33.78779,-117.85311

Key Eligibility Criteria

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 bipheno…
Limited prior therapy, including hydroxyurea for 72 hours or less, systemic glucocorticoids for one week or less, cytarabine for 72 hours or less, …
Written informed consent following Institutional Review Board, NCI, FDA, and OHRP Guidelines.

For full eligibility, visit ClinicalTrials.gov.

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