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New hope for kids with blood cancer: tailored treatments aim to boost cure rates and cut side effects

NCT ID NCT03117751

Disease control Sponsor: St. Jude Children's Research Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether using each child's unique genetic information to guide treatment can improve outcomes for acute lymphoblastic leukemia and lymphoma. About 790 children aged 1-18 will receive a combination of chemotherapy and newer targeted therapies, such as CAR T cells or blinatumomab, based on their cancer's genetic features. The trial also aims to reduce nerve damage by adjusting vincristine doses for those at higher risk.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
combination chemotherapy with targeted drugs (e.g., tyrosine kinase inhibitors, CAR T cells, blinatumomab, bortezomib, ruxolitinib, nelarabine) and reduced-dose vincristine
What this could lead to
If successful, this could improve survival and reduce nerve damage from chemotherapy for children with these blood cancers.
What could go wrong
This is an early-to-mid stage trial combining many new approaches, so results may not confirm benefit. Side effects from the intensive therapy could be serious.

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 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

790 people

The number who actually took part.

Started

Mar 2017

Expected to finish

Sep 2028

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: * Diagnosis of B- or T-ALL or LLy by immunophenotyping: * LLy participants must have \< 25% tumor cells in bone marrow and peripheral blood by morphology and flow cytometry. If any of these show ≥25% blasts, patient will be considered to have leukemia. Patients with MPAL are eligible. * Age 1-18 years (inclusive). * No prior therapy, or limited prior therapy, including systemic glucocorticoids for one week or less, one dose of vincristine, emergency radiation therapy (e.g., to the mediastinum, head and neck, orbit, etc.) and one dose of intrathecal chemotherapy. * Written, informed consent and assent following Institutional Review Board (IRB), National Cancer Institute (NCI), Food and Drug Administration (FDA), and Office of Human Research Protections (OHRP) Guidelines. Exclusion Criteria: * Participants who are pregnant or lactating. Males or females of reproductive potential must agree to use effective contraception for the duration of study participation. * Inability or unwillingness of research participant or legal guardian/representative to give written informed consent.

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Conditions

The condition(s) this trial relates to.

acute lymphoblastic leukemia leukemia lymphoblastic lymphoma lymphoma mixed phenotype acute leukemia Precursor Cell Lymphoblastic Leukemia-Lymphoma

As listed by the trial registrant

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

Acute lymphoblastic leukemia Acute lymphoblastic lymphoma

Contacts and locations

Locations

  • Children's Hospital of Illinois at OSF-Saint Francis Medical Center (St. Jude Midwest Affiliate - Peoria)

    Peoria, Illinois, 61637, United States

  • Children's Hospital of Michigan

    Detroit, Michigan, 48201, United States

  • Cook Children's Medical Center

    Fort Worth, Texas, 76104, United States

  • Lucile Packard Children's Hospital Stanford University

    Palo Alto, California, 94305, United States

  • Rady Children's Hospital San Diego

    San Diego, California, 92123, United States

  • St. Jude Affiliate Clinic - Novant Health Hemby Children's Hospital

    Charlotte, North Carolina, 28204, United States

  • St. Jude Children's Research Hospital

    Memphis, Tennessee, 38105, United States

  • The Royal Children's Hospital Melbourne

    Parkville, Victoria, 3052, Australia

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