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
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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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(24)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05848687