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Two-Drug combo aims to wipe out childhood leukemia faster

NCT ID NCT06533748

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 17, 2026 · Updated 2 times

Summary

This study tests whether giving two targeted immunotherapy drugs (inotuzumab and blinatumomab) together at the start of treatment can eliminate leukemia cells more effectively than standard chemotherapy in children and young adults (ages 1-18) with newly diagnosed B-cell acute lymphoblastic leukemia or lymphoma. The goal is to achieve a deep remission with no detectable cancer cells after about one month of therapy. The trial enrolls 128 participants at high risk of relapse and compares results to previous standard treatments.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 128 people

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

Started

Jan 2025

Expected to finish

May 2034

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

1 year to 18 years

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: * Enrollment on INITIALL. * Age 1-18.99 years at the time of enrollment on INITIALL. * B-Acute lymphoblastic leukemia or lymphoblastic lymphoma. * No prior chemotherapy excluding therapy given on or allowed by INITIALL. * NCI high-risk (age 10 years or greater or presenting WBC count ≥50,000 cells/microL) or NCI standard-risk and a HR clinical feature as listed below: * CNS3 disease (≥5 WBC/microL CSF with blasts present) * Testicular involvement of leukemia * Steroid pretreatment defined as \>24 hours of therapy in the 14 days prior to enrollment on INITIALL if a preceding WBC to define NCI risk is unavailable * For lymphoblastic lymphoma, Stage 3-4 disease OR Stage 1-2 disease in patient ages ≥10 years OR HR clinical feature as defined above. * Adequate liver function defined as: * Total bilirubin ≤ 1.5x the upper limit of normal for age and alanine transaminase (ALT) ≤ 5x the upper limit of normal for age. Patients with an elevated total bilirubin due to hemolysis are eligible if they have a direct bilirubin \<1.5x the upper limit of normal. * Adequate renal function defined as: * Calculated glomerular filtration rate (GFR) ≥ 50 mL/min/1.73m\^2 using the Bedside Schwartz equation OR creatinine below or equal to the maximum defined below: * Age: 1 to \<2 years; maximum serum creatinine (mg/dL): 0.6 (male and female) * Age: 2 to \<6 years; maximum serum creatinine (mg/dL): 0.8 (male and female) * Age: 6 to \<10 years; maximum serum creatinine (mg/dL): 1.0 (male and female) * Age: 10 to \<13 years; maximum serum creatinine (mg/dL): 1.2 (male and female) * Age: 13 to \<16 years; maximum serum creatinine (mg/dL): 1.5 (male); 1.4 (female) * Age: ≥16 years; maximum serum creatinine (mg/dL): 1.7 (male); 1.4 (female) * Eligibility for inclusion post-induction requires meeting the first 4 Inclusion criteria above AND: * Treatment on SJALL23H for Induction OR * Lymphoblastic lymphoma, initially treated on an SJALL protocol OR standard (non-protocol) therapy, without a complete response at the end of induction OR * NCI-SR ALL at diagnosis and treated with an SJALL protocol OR standard (non-protocol) therapy who have * Slow response to therapy (≥0.1% MRD at end of induction for patients with hyperdiploid ALL or ≥0.01% MRD at end of induction for others with ALL) OR * HR genetics as defined in the protocol. * These patients may receive no more than 2 weeks of post-induction therapy and should be transitioned to SJALL23H post-induction as soon as the qualifying genetic or MRD result is available. Exclusion Criteria: * Presence of ETV6::RUNX1 fusion unless also having a HR clinical feature OR slow response to induction therapy. * History or presence of clinically relevant central nervous system (CNS) pathology or event such as epilepsy, childhood or adult non-febrile seizure, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis. History of simple febrile seizure during childhood and presence of CNS leukemia at diagnosis are not exclusions to participation. * Active uncontrolled infection. * Current active autoimmune disease or history of autoimmune disease with the potential for CNS involvement. * History of venoocclusive disease/ sinusoidal obstructive syndrome. * Unstable cardiac disease including QTc \>500msec. * Inability or unwillingness to give informed consent/ assent as applicable. * Pregnant or lactating. * For patients of reproductive potential, unwillingness to use effective contraception for the duration of protocol therapy.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

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

    3 sites. 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

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Novant Health Presbyterian Hemby Children's Hospital

    RECRUITING

    Charlotte, North Carolina, 28204, United States

  • Saint Francis Children's Hospital

    RECRUITING

    Tulsa, Oklahoma, 74136, United States

  • St. Jude Children's Research Hospital

    RECRUITING

    Memphis, Tennessee, 38105, United States

    Contact Email: •••••@•••••

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