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TINI 2: Total Therapy for Infants With Acute Lymphoblastic Leukemia II
Sponsor: Tanja Andrea Gruber
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.
Key Details
Gender
All
Age Range
Any - 1 Year
Study Type
INTERVENTIONAL
Enrollment
90
Start Date
2023-11-03
Completion Date
2033-12
Last Updated
2026-01-13
Healthy Volunteers
No
Conditions
Interventions
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
Locations (25)
Phoenix Children's Hospital
Phoenix, Arizona, United States
Arkansas Children's Hospital
Little Rock, Arkansas, United States
Children's Hospital Los Angeles
Los Angeles, California, United States
Valley Children's Hospital
Madera, California, United States
Children's Hospital of Orange County
Orange, California, United States
Stanford University
Palo Alto, California, United States
Rady Children's Hospital San Diego
San Diego, California, United States
Arnold Palmer Hospital for Children
Orlando, Florida, United States
Children's Hospital of Minnesota
Minneapolis, Minnesota, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Novant Health - Hemby Children's Hospital
Charlotte, North Carolina, United States
Doernbecher Children's Hospital
Portland, Oregon, United States
Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania, United States
MD Anderson
Houston, Texas, United States
University of Texas Health Science Center San Antonio
San Antonio, Texas, United States
University of Utah Huntsman Cancer Institute
Salt Lake City, Utah, United States
Children's Hospital of The King's Daughters
Norfolk, Virginia, United States
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, United States
Alberta Children's Hospital
Calgary, Alberta, Canada
Stollery Children's Hospital
Edmonton, Alberta, Canada
BC Children's Hospital
Vancouver, British Columbia, Canada
McMaster Children's Hospital
Hamilton, Ontario, Canada
CHU Sainte-Justine
Montreal, Quebec, Canada
Montreal Children's Hospital
Montreal, Quebec, Canada
Chu De Quebec
Québec, Quebec, Canada