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

May 31, 2026 updated by: Tanja Andrea Gruber
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

90

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T3B 6A8
        • Not yet recruiting
        • Alberta Children's Hospital
        • Principal Investigator:
          • Victor Lewis, MD
        • Contact:
      • Edmonton, Alberta, Canada, T6G 2B7
        • Not yet recruiting
        • Stollery Children'S Hospital
        • Contact:
        • Principal Investigator:
          • Sunil J Desai, MD
    • British Columbia
      • Vancouver, British Columbia, Canada, V6H 3V4
        • Not yet recruiting
        • BC Children's Hospital
        • Principal Investigator:
          • Amanda Li, MD
        • Contact:
          • Amanda Li, MD
          • Phone Number: 1-604-875-2345
          • Email: ali3@cw.bc.ca
    • Ontario
      • Hamilton, Ontario, Canada, L8N 3Z5
        • Not yet recruiting
        • McMaster Children's Hospital
        • Contact:
        • Principal Investigator:
          • Uma Athale, MD
    • Quebec
      • Montreal, Quebec, Canada, H3T 1C5
      • Montreal, Quebec, Canada, H4A 3J1
        • Not yet recruiting
        • Montreal Children's Hospital
        • Contact:
        • Principal Investigator:
          • Stephanie Mourad, MD
      • Québec, Quebec, Canada, G1V 4G2
        • Not yet recruiting
        • CHU de Québec
        • Principal Investigator:
          • Bruno Michon, MD
        • Contact:
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85016
        • Recruiting
        • Phoenix Children's Hospital
        • Principal Investigator:
          • Dana Salzberg, MD
        • Contact:
    • Arkansas
      • Little Rock, Arkansas, United States, 72202
        • Recruiting
        • Arkansas Children's Hospital
        • Principal Investigator:
          • Kevin Bielamowicz, MD
        • Contact:
    • California
      • Los Angeles, California, United States, 90027
        • Recruiting
        • Children's Hospital Los Angeles
        • Principal Investigator:
          • Deepa Bhojwani, MD
        • Contact:
        • Contact:
      • Madera, California, United States, 93636
        • Recruiting
        • Valley Children's Hospital
        • Contact:
        • Principal Investigator:
          • Faisal Razzaqi, MD
      • Orange, California, United States, 92868
        • Recruiting
        • Children's Hospital of Orange County
        • Principal Investigator:
          • Jamie N Frediani, MD
        • Contact:
        • Contact:
      • Palo Alto, California, United States, 94304
        • Recruiting
        • Stanford University
        • Contact:
      • San Diego, California, United States, 92123
        • Not yet recruiting
        • Rady Children's Hospital San Diego
        • Principal Investigator:
          • Deborah Schiff, MD
        • Contact:
    • Florida
      • Orlando, Florida, United States, 32806
    • Minnesota
      • Minneapolis, Minnesota, United States, 55404
    • New York
      • New York, New York, United States, 10065
        • Recruiting
        • Memorial Sloan Kettering Cancer Center
        • Contact:
        • Principal Investigator:
          • Tanya Trippett, MD
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Not yet recruiting
        • Novant Health - Hemby Children's Hospital
        • Contact:
        • Principal Investigator:
          • Christine Bolen, MD
    • Oregon
      • Portland, Oregon, United States, 97239
        • Recruiting
        • Doernbecher Children's Hospital
        • Contact:
          • Bill Hoon Chang, Md, PhD
          • Phone Number: 503-346-0640
          • Email: changb@ohsu.edu
        • Principal Investigator:
          • Bill Hoon Chang, MD, PhD
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033-0850
        • Recruiting
        • Penn State Milton S Hershey Medical Center
        • Principal Investigator:
          • Valerie Brown, Md, PhD
        • Contact:
    • Texas
      • Houston, Texas, United States, 77030
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • University of Texas Health Science Center San Antonio
        • Principal Investigator:
          • Anne-Marie Langevin, MD
        • Contact:
    • Utah
      • Salt Lake City, Utah, United States, 84108
        • Recruiting
        • University of Utah Huntsman Cancer Institute
        • Contact:
        • Principal Investigator:
          • David Mangum, MD
    • Virginia
      • Norfolk, Virginia, United States, 23507
        • Recruiting
        • Children's Hospital of The King's Daughters
        • Principal Investigator:
          • Eric Lowe, MD
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Drug: Mitoxantrone
Given IV
Drug: Bortezomib
Given IV
Drug: Dexamethasone
Given orally (PO) or naso-gastrically (NG) or intravenously (IV).
Drug: Mercaptopurine
Given PO or NG.
Drug: PEG asparaginase
Given IV
Drug: Vorinostat
Taken PO or NG
Drug: Methotrexate
Given IV, IM or PO
Drug: Blinatumomab
Will be administered at 15 mcg/m2/day for 28 days following induction and reinduction
Drug: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Minimal Residual Disease
Time Frame: 5 years and 2 months
Proportion of patients who are minimal residual disease positive at the end of Induction Intensification
5 years and 2 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Event Free Survival
Time Frame: 8 years
To estimate the 3-year event-free survival for subjects treated on study
8 years
Overall Survival
Time Frame: 8 years
To estimate the 3-year overall survival for subjects treated on study
8 years
Ziftomenib Minimum safe and Biologically-Effective Dose in Combination with Chemotherapy
Time Frame: 5 years and 6 months
To determine the estimated minimum safe and biologically-effective dose of Ziftomenib in combination with chemotherapy, on the basis of observed DLTs, MRD assessments, and pharmacokinetic studies
5 years and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tanja Andrea Gruber

Collaborators

United States Department of Defense
Amgen
Kura Oncology, Inc.
Lucile Packard Foundation for Children's Health
Cannonball Kid's Cancer
The Pediatric Oncology Experimental Therapeutics Investigators' Consortium

Investigators

  • Principal Investigator: Tanja A Gruber, MD, PhD, Stanford University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 3, 2023

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2033

Study Registration Dates

First Submitted

April 27, 2023

First Submitted That Met QC Criteria

April 27, 2023

First Posted (Actual)

May 8, 2023

Study Record Updates

Last Update Posted (Actual)

June 3, 2026

Last Update Submitted That Met QC Criteria

May 31, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-68271
  • PEDSHEMALL0015 (Other Identifier: Stanford OnCore)
  • NCI-2023-04129 (Registry Identifier: NCI Clinical Trials Reporting Program (CTRP))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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