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

This study, called TINI 2, is for infants up to one year old who have newly diagnosed acute lymphoblastic leukemia (ALL) or acute undifferentiated leukemia. It aims to improve on a previous treatment for this type of cancer. The study will test an immunotherapy called blinatumomab, which targets a specific marker (CD19) on leukemia cells, to see if it can clear any remaining leukemia. Other treatments used in this study include Dexamethasone, Mitoxantrone, PEG asparaginase, Bortezomib, and Vorinostat. The main goal is to measure how much leukemia is left (Minimal Residual Disease) after 5 years and 2 months. The study is currently recruiting up to 90 participants.

Study design
This is an interventional study with a planned enrollment of 90 participants. The phase of the study is not specified.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed to measure Minimal Residual Disease at 5 years and 2 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05848687

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

Recruiting
PHASE1Up to 1InterventionalTreatment
Tanja Andrea Gruber
~90 participants
Updated 2026-06-03 on ClinicalTrials.gov
What's tested:DexamethasoneMitoxantronePEG asparaginaseBortezomibVorinostatMercaptopurine

At a glance

Recruiting sites
15 of 24 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Minimal Residual Disease
Measured over 5 years and 2 months

Conditions

Lymphoblastic Leukemia

Explore related trials

Acute Bilineal LeukemiaAcute Biphenotypic LeukemiaAcute Lymphoblastic LeukemiaAcute Undifferentiated LeukemiaCD19 GeneKMT2A Gene

NCT05848687

Where you'd take part

This study runs at 24 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Alberta Children's Hospital

    Calgary, Alberta, Canadastudy coordinator listed

    Not yet recruiting

  • Arkansas Children's Hospital

    Little Rock, Arkansasstudy coordinator listed

    Recruiting

  • Arnold Palmer Hospital for Children

    Orlando, Floridastudy coordinator listed

    Recruiting

  • BC Children's Hospital

    Vancouver, British Columbia, Canadastudy coordinator listed

    Not yet recruiting

  • Children's Hospital Los Angeles

    Los Angeles, Californiastudy coordinator listed

    Recruiting

  • Children's Hospital of Minnesota

    Minneapolis, Minnesotastudy coordinator listed

    Recruiting

  • Children's Hospital of Orange County

    Orange, Californiastudy coordinator listed

    Recruiting

  • Children's Hospital of The King's Daughters

    Norfolk, Virginiastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Tanja A Gruber, MD, PhD · PRINCIPAL_INVESTIGATOR · Stanford University

Who to contact

Tanja A Gruber, MD, PhD
[email protected]
650 723 5535
Email the study team

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Eligibility criteria

Inclusion

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.
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

What this trial measures

  • Minimal Residual Disease5 years and 2 months

    Proportion of patients who are minimal residual disease positive at the end of Induction Intensification