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Clinical Trials in Canada / NCT05848687
Recruiting Phase 1/2

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

NCT05848687 · tracked via the Priya Life Science Canada tracker
Sponsor
Tanja Andrea Gruber
Phase
Phase 1/2
Started
2023-11-03
Last updated
2026-06-03

Condition(s) studied

Lymphoblastic Leukemia

Investigational drug(s) / intervention(s)

Dexamethasone →Mitoxantrone →PEG asparaginase →Bortezomib →Vorinostat →Mercaptopurine →Methotrexate →Blinatumomab →Ziftomenib →

Dexamethasone: Given orally (PO) or naso-gastrically (NG) or intravenously (IV).

Mitoxantrone: Given IV

PEG asparaginase: Given IV

Bortezomib: Given IV

Vorinostat: Taken PO or NG

Mercaptopurine: Given PO or NG.

Methotrexate: Given IV, IM or PO

Blinatumomab: Will be administered at 15 mcg/m2/day for 28 days following induction and reinduction

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

Study 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

Sex
ALL
Min age
—
Max age
1 Year
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. * Written informed consent following Institutional Review Board, NCI, FDA, and OHRP Guidelines. Exclusion Criteria: * Patients with prior therapy, other than therapy specified in inclusion criteria. * 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

Primary outcome measure(s)

Trial sites (24)

FacilityCityRegionStatus
Phoenix Children's Hospital Phoenix Arizona Recruiting
Arkansas Children's Hospital Little Rock Arkansas Recruiting
Children's Hospital Los Angeles Los Angeles California Recruiting
Valley Children's Hospital Madera California Recruiting
Children's Hospital of Orange County Orange California Recruiting
Stanford University Palo Alto California Recruiting
Rady Children's Hospital San Diego San Diego California Not Yet Recruiting
Arnold Palmer Hospital for Children Orlando Florida Recruiting
Children's Hospital of Minnesota Minneapolis Minnesota Recruiting
Memorial Sloan Kettering Cancer Center New York New York Recruiting
Novant Health - Hemby Children's Hospital Charlotte North Carolina Not Yet Recruiting
Doernbecher Children's Hospital Portland Oregon Recruiting
Penn State Milton S Hershey Medical Center Hershey Pennsylvania Recruiting
MD Anderson Houston Texas Recruiting
University of Texas Health Science Center San Antonio San Antonio Texas Recruiting
University of Utah Huntsman Cancer Institute Salt Lake City Utah Recruiting
Children's Hospital of The King's Daughters Norfolk Virginia Recruiting
Alberta Children's Hospital Calgary Alberta Not Yet Recruiting
Stollery Children's Hospital Edmonton Alberta Not Yet Recruiting
BC Children's Hospital Vancouver British Columbia Not Yet Recruiting
McMaster Children's Hospital Hamilton Ontario Not Yet Recruiting
CHU Sainte-Justine Montreal Quebec Not Yet Recruiting
Montreal Children's Hospital Montreal Quebec Not Yet Recruiting
Chu De Quebec Québec Quebec Not Yet Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05848687 on ClinicalTrials.gov ↗ ← All trials in Canada