TINI 2: Total Therapy for Infants With Acute Lymphoblastic Leukemia II
NCT ID: NCT05848687
Last Updated: 2026-01-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
90 participants
INTERVENTIONAL
2023-11-03
2033-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment
Participants who meet eligibility criteria will receive remission induction, induction intensification, consolidation I, reinduction block I, reinduction block II, consolidation II, and Maintenance.
Interventions: Dexamethasone, Mitoxantrone, PEG-asparaginase, Bortezomib, Vorinostat, Mercaptopurine, Methotrexate and Vincristine, 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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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.
* 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
1 Year
ALL
No
Sponsors
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Pediatric Oncology Experimental Therapeutics Investigators' Consortium
UNKNOWN
Amgen
INDUSTRY
Lucile Packard Foundation for Children's Health
UNKNOWN
Kura Oncology, Inc.
INDUSTRY
United States Department of Defense
FED
Cannonball Kid's Cancer
UNKNOWN
Tanja Andrea Gruber
OTHER
Responsible Party
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Tanja Andrea Gruber
Faculty - Hematology/Oncology
Principal Investigators
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Tanja A Gruber, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Stanford University
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Role: backup
Other Identifiers
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PEDSHEMALL0015
Identifier Type: OTHER
Identifier Source: secondary_id
IRB-68271
Identifier Type: -
Identifier Source: org_study_id
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