Actively Recruiting
TINI 2: Total Therapy for Infants With Acute Lymphoblastic Leukemia II
Led by Tanja Andrea Gruber · Updated on 2026-04-20
90
Participants Needed
24
Research Sites
525 weeks
Total Duration
On this page
Sponsors
T
Tanja Andrea Gruber
Lead Sponsor
T
The Pediatric Oncology Experimental Therapeutics Investigators' Consortium
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
TINI 2: Total Therapy for Infants With Acute Lymphoblastic Leukemia II
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient is 64 365 days of age at the time of diagnosis.
- Patient has newly diagnosed CD19 positive acute lymphoblastic leukemia or acute undifferentiated leukemia.
- Subjects with bilineage or biphenotypic acute leukemia are eligible if they express CD19.
- Patients with CD19 positive mature B-cell ALL with KMT2A rearrangement are eligible.
- Limited prior therapy allowed: 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.
You will not qualify if you...
- Patients with prior therapy other than those specified in inclusion criteria.
- Patients with mature B-cell ALL without KMT2A rearrangement.
- Patients with acute myelogenous leukemia or T-cell ALL.
- Patients with Down syndrome.
- Inability or unwillingness of legal guardian to give written informed consent.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 24 locations
1
Phoenix Children's Hospital
Phoenix, Arizona, United States, 85016
Actively Recruiting
2
Arkansas Children's Hospital
Little Rock, Arkansas, United States, 72202
Actively Recruiting
3
Children's Hospital Los Angeles
Los Angeles, California, United States, 90027
Actively Recruiting
4
Valley Children's Hospital
Madera, California, United States, 93636
Actively Recruiting
5
Children's Hospital of Orange County
Orange, California, United States, 92868
Actively Recruiting
6
Stanford University
Palo Alto, California, United States, 94304
Actively Recruiting
7
Rady Children's Hospital San Diego
San Diego, California, United States, 92123
Not Yet Recruiting
8
Arnold Palmer Hospital for Children
Orlando, Florida, United States, 32806
Actively Recruiting
9
Children's Hospital of Minnesota
Minneapolis, Minnesota, United States, 55404
Actively Recruiting
10
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
11
Novant Health - Hemby Children's Hospital
Charlotte, North Carolina, United States, 28204
Not Yet Recruiting
12
Doernbecher Children's Hospital
Portland, Oregon, United States, 97239
Actively Recruiting
13
Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania, United States, 17033-0850
Not Yet Recruiting
14
MD Anderson
Houston, Texas, United States, 77030
Actively Recruiting
15
University of Texas Health Science Center San Antonio
San Antonio, Texas, United States, 78229
Actively Recruiting
16
University of Utah Huntsman Cancer Institute
Salt Lake City, Utah, United States, 84108
Not Yet Recruiting
17
Children's Hospital of The King's Daughters
Norfolk, Virginia, United States, 23507
Actively Recruiting
18
Alberta Children's Hospital
Calgary, Alberta, Canada, T3B 6A8
Not Yet Recruiting
19
Stollery Children's Hospital
Edmonton, Alberta, Canada, T6G 2B7
Not Yet Recruiting
20
BC Children's Hospital
Vancouver, British Columbia, Canada, V6H 3V4
Not Yet Recruiting
21
McMaster Children's Hospital
Hamilton, Ontario, Canada, L8N 3Z5
Not Yet Recruiting
22
CHU Sainte-Justine
Montreal, Quebec, Canada, H3T 1C5
Not Yet Recruiting
23
Montreal Children's Hospital
Montreal, Quebec, Canada, H4A 3J1
Not Yet Recruiting
24
Chu De Quebec
Québec, Quebec, Canada, G1V 4G2
Not Yet Recruiting
Research Team
T
Tanja A Gruber, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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