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NCT Number: NCT05848687

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

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.

Recruiting

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Key information

Conditions

Lymphoblastic Leukemia Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Precursor Cell Lymphoblastic Leukemia-Lymphoma

Age range

Up to 1 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Alberta Children's Hospital, Calgary, Alberta, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexamethasone

Drug

Given orally (PO) or naso-gastrically (NG) or intravenously (IV).

Mitoxantrone

Drug

Given IV

PEG asparaginase

Drug

Given IV

bortezomib

Drug

Given IV

Vorinostat

Drug

Taken PO or NG

mercaptopurine

Drug

Given PO or NG.

methotrexate

Drug

Given IV, IM or PO

Blinatumomab

Drug

Will be administered at 15 mcg/m2/day for 28 days following induction and reinduction

Ziftomenib

Drug

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. Event Free Survival

    Time frame: 8 years

    To estimate the 3-year event-free survival for subjects treated on study

  3. Overall Survival

    Time frame: 8 years

    To estimate the 3-year overall survival for subjects treated on study

Study contacts

Contact information is provided by the study sponsor or research team.

Tanja A Gruber, MD, PhD

CONTACT

[email protected]

650 723 5535

Sponsors and collaborators

Lead sponsor

Tanja Andrea Gruber

Other

Collaborators

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

Registry information

Important dates

Study start
2023
Primary completion
2028
Study completion
2033
First posted
May 8, 2023
Registry last updated
Jun 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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