Promising new combo aims to tame childhood leukemia with less chemo
NCT ID NCT07152041
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This clinical trial is testing a new combination of drugs for children and teens with a specific type of leukemia called Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL). The study uses a targeted drug called olverembatinib along with immune therapy (blinatumomab) and another targeted drug (venetoclax) to try to kill leukemia cells more effectively while using less traditional chemotherapy. The goal is to see if this approach leads to better remission rates with fewer side effects. The trial plans to enroll 150 participants aged 1 month to 18 years who are newly diagnosed.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- olverembatinib (a targeted drug), blinatumomab (an immune therapy), and venetoclax (a targeted drug)
- What this could lead to
- If successful, this could offer a more effective and less toxic treatment option for children with Ph+ acute lymphoblastic leukemia, potentially improving remission rates and reducing side effects from chemotherapy.
- What could go wrong
- This is an early-phase 3 trial with a relatively small sample size (150 participants). The new combination may not prove superior to current treatments, and there are risks of serious side effects from the immune therapy and targeted drugs.
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
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 150 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2025
- Expected to finish
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Jun 2030
An estimate. End dates often move.
- Lead sponsor
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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
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1 month to 18 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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: Must meet all items below: 1. Age older than 1 month to younger 18 years. 2. Newly diagnosed Philadelphia chromosome-positive or BCR::ABL1-positive B-ALL. 3. Written informed consent of the parents or other legally authorized guardian of the patient according to local law and regulations. Exclusion Criteria: Should be excluded if had any item below: 1. ALL evolved from CML. 2. Known underlying congenital immunodeficiency or metabolic disease. 3. Congenital heart disease with cardiac insufficiency. 4. Gastrointestinal dysfunction or gastrointestinal diseases that may significantly alter the absorption of study drug. 5. Severe malnutrition, uncontrolled active infections, or serious cardiovascular diseases. 6. Subjects with significant CNS disorder (e.g., uncontrolled seizure disorder, autoimmune disease involving CNS). 7. Treated with glucocorticoids for ≥14 days, or targeted inhibitor for \> 7 days within one month before enrollment, or any chemotherapy or any systemic anticancer therapy (including but not limited to any TKI) or radiotherapy within 3 months before enrollment (except for emergency radiotherapy to relieve airway compression). 8. Any significant comorbidities or psychiatric disorders that may impact patient safety, compliance, informed consent, study participation, follow-up, or the interpretation of study results. In such cases, all participating sites must report directly to the PI to determine whether the patient meets exclusion criteria.
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Get notified about this study
Sign up to get updates when this study changes or when new studies for Acute lymphoblastic leukemia (ALL) philadelphia chromosome-positive (PH+) are added.
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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.
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The places running it
24 sites in 2 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Affiliated Hospital of Qingdao University
NOT_YET_RECRUITINGQingdao, Shandong, China
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Anhui Medical University Second Affiliated Hospita
NOT_YET_RECRUITINGHefei, Anhui, China
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Children's Hospital of Fudan University
NOT_YET_RECRUITINGShanghai, Shanghai Municipality, China
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Children's Hospital of Soochow University
NOT_YET_RECRUITINGSuzhou, Jiangsu, China
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Chongqing Medical University Affiliated Children's Hospital
NOT_YET_RECRUITINGChongqing, Chongqing Municipality, China
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Fujian Medical University Union Hospital
NOT_YET_RECRUITINGFuzhou, Fujian, China
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Guangzhou Women and Children's Medical Center
NOT_YET_RECRUITINGGuangzhou, Guangdong, China
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Hong Kong Children's Hospital, The Chinese University of Hong Kong
NOT_YET_RECRUITINGHong Kong, Hong Kong
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Hunan Children's Hospital
NOT_YET_RECRUITINGChangsha, Hunan, China
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Institute of Hematology and Blood Diseases Hospital, CAMS & PUMC
RECRUITINGTianjin, Tianjin Municipality, China
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Institute of Hematology and Blood Diseases Hospital, CAMS & PUMC
NOT_YET_RECRUITINGTianjin, Tianjin Municipality, China
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Jiangxi Provincial Children's Hospital
NOT_YET_RECRUITINGNanchang, Jiangxi, China
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Nanfang Hospital, Southern Medical University
NOT_YET_RECRUITINGGuangzhou, Guangdong, China
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Nanjing Children's Hospital Affiliated to Nanjing Medical University
NOT_YET_RECRUITINGNanjin, Jiangsu, China
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Qilu Hospital of Shandong University
NOT_YET_RECRUITINGJinan, Shandong, China
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Shanghai Children's Hospital
NOT_YET_RECRUITINGShanghai, Shanghai Municipality, China
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Shenzhen Children's Hospital
NOT_YET_RECRUITINGShenzhen, Shenzhen, China
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The Affiliated Hospital of Guizhou Medical University
NOT_YET_RECRUITINGGuiyang, Guizhou, China
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The First Affiliated Hospital, Sun Yat-sen University
NOT_YET_RECRUITINGGuangzhou, Guangdong, China
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The Third Xiangya Hospital of the Central South University
NOT_YET_RECRUITINGChangsha, Hunan, China
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Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
NOT_YET_RECRUITINGWuhan, Hubei, China
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Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
NOT_YET_RECRUITINGWuhan, Hubei, China
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West China Second University Hospita
NOT_YET_RECRUITINGChengdu, Sichuan, China
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Wuhan Children's Hospital
NOT_YET_RECRUITINGWuhan, Hubei, China
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