Clinical trial NCT05848687: TINI 2: Total Therapy for Infants With Acute Lymphoblastic Leukemia II
Official title: TINI 2: Total Therapy for Infants With Acute Lymphoblastic Leukemia II
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Lymphoblastic Leukemia
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: Pediatric Oncology Experimental Therapeutics Investigators' Consortium
name: Amgen
name: Lucile Packard Foundation for Children's Health
name: Kura Oncology, Inc.
First posted: 2023-05-08
Enrollment: 90
Sex: ALL
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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 criteria: 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 outcomes:
measure: Minimal Residual Disease
timeFrame: 5 years and 2 months
Secondary outcomes:
measure: Ziftomenib Minimum safe and Biologically-Effective Dose in Combination with Chemotherapy
timeFrame: 5 years and 6 months
measure: Event Free Survival
timeFrame: 8 years
measure: Overall Survival
timeFrame: 8 years
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Phoenix Children's Hospital
state: Arizona
city: Little Rock
country: United States
facility: Arkansas Children's Hospital
state: Arkansas
city: Los Angeles
country: United States
facility: Children's Hospital Los Angeles
state: California
city: Madera
country: United States
facility: Valley Children's Hospital
state: California
city: Orange
country: United States
facility: Children's Hospital of Orange County
state: California
city: Palo Alto
country: United States
facility: Stanford University
state: California
city: San Diego
country: United States
facility: Rady Children's Hospital San Diego
state: California
city: Orlando
country: United States
facility: Arnold Palmer Hospital for Children
state: Florida
city: Minneapolis
country: United States
facility: Children's Hospital of Minnesota
state: Minnesota
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Charlotte
country: United States
facility: Novant Health - Hemby Children's Hospital
state: North Carolina
city: Portland
country: United States
facility: Doernbecher Children's Hospital
state: Oregon
city: Hershey
country: United States
facility: Penn State Milton S Hershey Medical Center
state: Pennsylvania
city: Houston
country: United States
facility: MD Anderson
state: Texas
city: San Antonio
country: United States
facility: University of Texas Health Science Center San Antonio
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah Huntsman Cancer Institute
state: Utah
city: Norfolk
country: United States
facility: Children's Hospital of The King's Daughters
state: Virginia
city: Madison
country: United States
facility: University of Wisconsin Carbone Cancer Center
state: Wisconsin
city: Calgary
country: Canada
facility: Alberta Children's Hospital
state: Alberta
city: Edmonton
country: Canada
facility: Stollery Children's Hospital
state: Alberta
city: Vancouver
country: Canada
facility: BC Children's Hospital
state: British Columbia
city: Hamilton
country: Canada
facility: McMaster Children's Hospital
state: Ontario
city: Montréal
country: Canada
facility: CHU Sainte-Justine
state: Quebec
city: Montréal
country: Canada
facility: Montreal Children's Hospital
state: Quebec
city: Quebec City
country: Canada
facility: Chu De Quebec
state: Quebec
Study officials:
affiliation: Stanford University
name: Tanja A Gruber, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: