NCT05848687

TINI 2: Total Therapy for Infants With Acute Lymphoblastic Leukemia II

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Tanja Andrea Gruber · Academic / Other
• Sex: All
• Age: 1 Year
• Healthy volunteers: Not accepted

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.

Conditions

• Lymphoblastic Leukemia

Interventions

Type	Name	Description
DRUG	Dexamethasone	Given orally (PO) or naso-gastrically (NG) or intravenously (IV).
DRUG	Mitoxantrone	Given IV
DRUG	PEG asparaginase	Given IV
DRUG	Bortezomib	Given IV
DRUG	Vorinostat	Taken PO or NG
DRUG	Mercaptopurine	Given PO or NG.
DRUG	Methotrexate	Given IV, IM or PO
DRUG	Blinatumomab	Will be administered at 15 mcg/m2/day for 28 days following induction and reinduction
DRUG	Ziftomenib	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

Timeline

• Start date: 2023-11-03
• Primary completion: 2028-12-01
• Completion: 2033-12-01
• First posted: 2023-05-08
• Last updated: 2026-01-13

Locations

25 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study