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NCT07152041RecruitingPhase 3

Newly-diagnosed Pediatric Ph-positive B-ALL Protocol

A Phase 3, Multicenter Trial for Pediatric Philadelphia Chromosome-positive B-Acute Lymphoblastic Leukemia -2025 Project

Source: ClinicalTrials.gov · Last updated 3 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

This prospective clinical trial evaluates the effectiveness and safety of "chemotherapy-light" regimen incorporating the third-generation TKI olverembatinib, the bi-specific CD3/CD19 T cell engager blinatumomab, and the BCL-2 selective inhibitor venetoclax for newly diagnosed pediatric/adolescent patients with Ph+ ALL. The CCCG-Ph+ B-ALL-2025 protocol will be modified as following compared to the CCCG-ALL-2020 protocol

Status (registry)
Recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
150 (estimated)
First submitted
28 Mar 2025
Start date
28 Mar 2025
Primary completion date
Dec 2029
Lead sponsor
Institute of Hematology & Blood Diseases Hospital, China
NCT number
NCT07152041

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 150
  • From 28 Mar 2025 to the primary completion date, Dec 2029
  • 23 sites in 2 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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).

Other illness

  • Known underlying congenital immunodeficiency or metabolic disease.
  • Congenital heart disease with cardiac insufficiency.
  • Gastrointestinal dysfunction or gastrointestinal diseases that may significantly alter the absorption of study drug.
  • Severe malnutrition, uncontrolled active infections, or serious cardiovascular diseases.
  • Subjects with significant CNS disorder (e.g., uncontrolled seizure disorder, autoimmune disease involving CNS).
  • 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.

Other

  • Should be excluded if had any item below:
  • ALL evolved from CML.

Who the study is looking for

  • Must meet all items below:
  • Age older than 1 month to younger 18 years.
  • Newly diagnosed Philadelphia chromosome-positive or BCR::ABL1-positive B-ALL.
  • Written informed consent of the parents or other legally authorized guardian of the patient according to local law and regulations.

Age in the registry: 1 month to 18 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (23)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
The Third Xiangya Hospital of the Central South University
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ChangshaChinaNot yet recruiting
Hunan Children's Hospital
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ChangshaChinaNot yet recruiting
West China Second University Hospita
Coordinator of this site? Confirm its status
ChengduChinaNot yet recruiting
Chongqing Medical University Affiliated Children's Hospital
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ChongqingChinaNot yet recruiting
Fujian Medical University Union Hospital
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FuzhouChinaNot yet recruiting
Guangzhou Women and Children's medical center
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GuangzhouChinaNot yet recruiting
Nanfang Hospital, Southern Medical University
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GuangzhouChinaNot yet recruiting
The First Affiliated Hospital, Sun Yat-sen University
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GuangzhouChinaNot yet recruiting
The Affiliated Hospital of Guizhou Medical University
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GuiyangChinaNot yet recruiting
Anhui Medical University Second Affiliated Hospita
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HefeiChinaNot yet recruiting
Qilu Hospital of Shandong University
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JinanChinaNot yet recruiting
Jiangxi Provincial Children's Hospital
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NanchangChinaNot yet recruiting
Nanjing Children's Hospital Affiliated to Nanjing Medical University
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NanjinChinaNot yet recruiting
Affiliated Hospital of Qingdao University
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QingdaoChinaNot yet recruiting
Children's Hospital Of Fudan University
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ShanghaiChinaNot yet recruiting
Shanghai Children's Hospital
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ShanghaiChinaNot yet recruiting
Shenzhen Children's Hospital
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ShenzhenChinaNot yet recruiting
Children's Hospital of Soochow University
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SuzhouChinaNot yet recruiting
Institute of Hematology and Blood Diseases Hospital, CAMS & PUMC
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TianjinChinaRecruiting
Union Hospital of Tongji Medical College Huazhong University of Science and Technology
Coordinator of this site? Confirm its status
WuhanChinaNot yet recruiting
Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
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WuhanChinaNot yet recruiting
Wuhan Children's Hospital
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WuhanChinaNot yet recruiting
Hong Kong Children's Hospital, The Chinese University of Hong Kong
Coordinator of this site? Confirm its status
Hong KongHong KongNot yet recruiting

This page is information, not medical advice. Discuss any trial with your doctor.