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Can targeted drugs blinatumomab and venetoclax improve outcomes for childhood leukemia?

NCT ID NCT06764238

Cure Sponsor: Institute of Hematology & Blood Diseases Hospital, China 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 23, 2026 · Last updated Jul 24, 2026 · Updated 1 time

Summary

This large trial is testing whether adding the targeted drugs blinatumomab or venetoclax to standard chemotherapy can improve survival and reduce side effects in children with intermediate- or high-risk B-cell acute lymphoblastic leukemia (ALL). The study compares different schedules of blinatumomab and also tests venetoclax in children who cannot receive blinatumomab. The goal is to find a more effective and less toxic treatment approach for this common childhood cancer.

What this could mean

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

Active substance
blinatumomab and venetoclax, drugs that target cancer cells
What this could lead to
If successful, this could lead to more effective, less toxic treatments for childhood B-cell ALL, potentially reducing the need for transplants and improving long-term survival.
What could go wrong
This is an early-to-mid-stage trial, and the new drug combinations may not prove superior to standard therapy. Side effects from blinatumomab or venetoclax could be significant.

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

About 1,800 people

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

Started

Jan 2025

Expected to finish

Jun 2031

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 month 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: 1. Age older than 1 month to younger than 18 years. 2. Diagnosis of acute lymphoblastic leukemia by bone marrow morphology. 3. Diagnosis of B-ALL by immunophenotyping. Exclusion Criteria: 1. Low-risk ALL 2. sIgM+ 3. Acute leukemias of ambiguous lineage diagnosed according to WHO or EGIL criteria. 4. ALL evolved from chronic myeloid leukemia (CML). 5. Down's syndrome, or major congenital or hereditary disease with organ dysfunction 6. Secondary leukemia 7. Known underlying congenital immunodeficiency or metabolic disease 8. Congenital heart disease with cardiac insufficiency. 9. Treated with glucocorticoids for ≥14 days, or ABL kinase inhibitors for \> 7 days within one month before enrollment, or any chemotherapy or radiotherapy within 3 months before enrollment (except for emergency radiotherapy to relieve airway compression)

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Conditions

The condition(s) this trial relates to.

acute lymphoblastic leukemia B-cell acute lymphoblastic leukemia Burkitt lymphoma childhood acute lymphoblastic 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 ALL B-cell acute lymphoblastic leukemia (B-ALL) Childhood leukemia, acute lymphoblastic

How to take part

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

  1. The places running it

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

  2. 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 ↗

  3. 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

  • Affiliated Hospital of Qingdao University

    NOT_YET_RECRUITING

    Qingdao, Shandong, China

  • Anhui Medical University Second Affiliated Hospital

    NOT_YET_RECRUITING

    Hefei, Anhui, China

  • Anhui Provincial Children's Hospital

    NOT_YET_RECRUITING

    Hefei, Anhui, China

  • Children's Hospital of Fudan University

    NOT_YET_RECRUITING

    Shanghai, China

  • Children's Hospital of Soochow University

    NOT_YET_RECRUITING

    Suzhou, Jiangsu, China

  • Chongqing Medical University Affiliated Children's Hospital

    NOT_YET_RECRUITING

    Chongqing, China

  • Fujian Medical University Union Hospital

    NOT_YET_RECRUITING

    Fuzhou, Fujian, China

  • Guangzhou Women and Children's Medical Center

    NOT_YET_RECRUITING

    Guangzhou, Guangdong, China

  • Hong Kong Children's Hospital

    NOT_YET_RECRUITING

    Hong Kong, Hong Kong

  • Hunan Children's Hospital

    NOT_YET_RECRUITING

    Changsha, Hunan, China

  • Institute of Hematology and Blood Diseases Hospital, CAMS & PUMC

    RECRUITING

    Tianjin, Tianjin Municipality, 300020, China

  • Jiangxi Provincial Children's Hospital

    NOT_YET_RECRUITING

    Nanchang, Jiangxi, China

  • Nanfang Hospital, Southern Medical University

    NOT_YET_RECRUITING

    Guangzhou, Guangdong, China

  • Nanjing Children's Hospital Affiliated to Nanjing Medical University

    NOT_YET_RECRUITING

    Nanjing, Jiangsu, China

  • Qilu Hospital of Shandong University

    NOT_YET_RECRUITING

    Jinan, Shandong, China

  • Shanghai Children's Hospital

    NOT_YET_RECRUITING

    Shanghai, China

  • Shanghai Children's Medical Cener, Shanghai Jiao Tong University School of Medicine

    NOT_YET_RECRUITING

    Shanghai, China

  • Shenzhen Children's Hospital

    NOT_YET_RECRUITING

    Shenzhen, Shenzhen, China

  • The Affiliated Hospital of Guizhou Medical University

    NOT_YET_RECRUITING

    Guiyang, Guizhou, China

  • The People's Hospital of Guangxi Zhuang Autonomous Region

    NOT_YET_RECRUITING

    Nanning, Guangxi, China

  • The Third Xiangya Hospital of the Central South University

    NOT_YET_RECRUITING

    Changsha, Hunan, China

  • Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology

    NOT_YET_RECRUITING

    Wuhan, Hubei, China

  • Union Hospital of Tongji Medical College, Huazhong University of Science and Technology

    NOT_YET_RECRUITING

    Wuhan, Hubei, China

  • West China Second University Hospital, Sichuan University

    NOT_YET_RECRUITING

    Chengdu, Sichuan, China

  • Wuhan Children's Hospital

    NOT_YET_RECRUITING

    Wuhan, Hubei, China

  • Xi'an Northwest Women and Children Hospital

    NOT_YET_RECRUITING

    Xi’an, Shanxi, China

  • Xiangya Hospital Central South University

    NOT_YET_RECRUITING

    Changsha, Hunan, China

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