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New hope for babies with leukemia: immunotherapy combo trial launches

NCT ID NCT05848687

Disease control Sponsor: Tanja Andrea Gruber Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a new treatment plan for infants (up to 12 months old) with a type of leukemia called acute lymphoblastic leukemia. The goal is to see if adding an immunotherapy drug called blinatumomab can better clear leukemia cells that remain after initial treatment. About 90 babies will take part to find the safest and most effective doses.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 90 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2023

Expected to finish

Dec 2033

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

Up to 1 year

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

acute leukemia of ambiguous lineage acute lymphoblastic leukemia acute undifferentiated leukemia B-lymphoblastic leukemia/lymphoma with t(v;11q23.3) bilineal acute myeloid leukemia Precursor Cell Lymphoblastic Leukemia-Lymphoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Lymphoblastic leukemia

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    24 sites in 2 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Alberta Children's Hospital

    NOT_YET_RECRUITING

    Calgary, Alberta, T3B 6A8, Canada

  • Arkansas Children's Hospital

    RECRUITING

    Little Rock, Arkansas, 72202, United States

  • Arnold Palmer Hospital for Children

    RECRUITING

    Orlando, Florida, 32806, United States

  • BC Children's Hospital

    NOT_YET_RECRUITING

    Vancouver, British Columbia, V6H 3V4, Canada

  • CHU Sainte-Justine

    NOT_YET_RECRUITING

    Montreal, Quebec, H3T 1C5, Canada

  • Children's Hospital Los Angeles

    RECRUITING

    Los Angeles, California, 90027, United States

  • Children's Hospital of Minnesota

    RECRUITING

    Minneapolis, Minnesota, 55404, United States

  • Children's Hospital of Orange County

    RECRUITING

    Orange, California, 92868, United States

  • Children's Hospital of The King's Daughters

    RECRUITING

    Norfolk, Virginia, 23507, United States

    Contact Email: •••••@•••••

  • Chu De Quebec

    NOT_YET_RECRUITING

    Québec, Quebec, G1V 4G2, Canada

  • Doernbecher Children's Hospital

    RECRUITING

    Portland, Oregon, 97239, United States

  • MD Anderson

    RECRUITING

    Houston, Texas, 77030, United States

  • McMaster Children's Hospital

    NOT_YET_RECRUITING

    Hamilton, Ontario, L8N 3Z5, Canada

  • Memorial Sloan Kettering Cancer Center

    RECRUITING

    New York, New York, 10065, United States

  • Montreal Children's Hospital

    NOT_YET_RECRUITING

    Montreal, Quebec, H4A 3J1, Canada

  • Novant Health - Hemby Children's Hospital

    NOT_YET_RECRUITING

    Charlotte, North Carolina, 28204, United States

  • Penn State Milton S Hershey Medical Center

    RECRUITING

    Hershey, Pennsylvania, 17033-0850, United States

  • Phoenix Children's Hospital

    RECRUITING

    Phoenix, Arizona, 85016, United States

  • Rady Children's Hospital San Diego

    NOT_YET_RECRUITING

    San Diego, California, 92123, United States

  • Stanford University

    RECRUITING

    Palo Alto, California, 94304, United States

  • Stollery Children's Hospital

    NOT_YET_RECRUITING

    Edmonton, Alberta, T6G 2B7, Canada

  • University of Texas Health Science Center San Antonio

    RECRUITING

    San Antonio, Texas, 78229, United States

  • University of Utah Huntsman Cancer Institute

    RECRUITING

    Salt Lake City, Utah, 84108, United States

  • Valley Children's Hospital

    RECRUITING

    Madera, California, 93636, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.