TINI 2: Total Therapy for Infants With Acute Lymphoblastic Leukemia II
Tanja Andrea Gruber
Summary
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.
Eligibility
- Age range
- Up to 1 years
- Sex
- All
- Healthy volunteers
- No
Inclusion 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 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. * W…
Interventions
- DrugDexamethasone
Given orally (PO) or naso-gastrically (NG) or intravenously (IV).
- DrugMitoxantrone
Given IV
- DrugPEG asparaginase
Given IV
- DrugBortezomib
Given IV
- DrugVorinostat
Taken PO or NG
- DrugMercaptopurine
Given PO or NG.
- DrugMethotrexate
Given IV, IM or PO
Locations (24)
- Phoenix Children's HospitalPhoenix, Arizona
- Arkansas Children's HospitalLittle Rock, Arkansas
- Children's Hospital Los AngelesLos Angeles, California
- Valley Children's HospitalMadera, California
- Children's Hospital of Orange CountyOrange, California
- Stanford UniversityPalo Alto, California