TINI 2: Total Therapy for Infants With Acute Lymphoblastic Leukemia II
Tanja Andrea Gruber
90 participants
Nov 3, 2023
INTERVENTIONAL
Conditions
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
Inclusion Criteria7
- 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.
- 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
Interventions
Given orally (PO) or naso-gastrically (NG) or intravenously (IV).
Given IV
Given IV
Given IV
Taken PO or NG
Given PO or NG.
Given IV, IM or PO
Will be administered at 15 mcg/m2/day for 28 days following induction and reinduction
3+3 dose escalation will be done. Dose level 1 will start at 75% of the adult recommended phase two dosing which has been established in phase I studies. Based on tolerability, we will either de-escalate to 50% RP2D (dose level -1) or escalate to 100% RP2D
Locations(25)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05848687