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
Sites (23)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Third Xiangya Hospital of the Central South University Coordinator of this site? Confirm its status | Changsha | China | Not yet recruiting |
| Hunan Children's Hospital Coordinator of this site? Confirm its status | Changsha | China | Not yet recruiting |
| West China Second University Hospita Coordinator of this site? Confirm its status | Chengdu | China | Not yet recruiting |
| Chongqing Medical University Affiliated Children's Hospital Coordinator of this site? Confirm its status | Chongqing | China | Not yet recruiting |
| Fujian Medical University Union Hospital Coordinator of this site? Confirm its status | Fuzhou | China | Not yet recruiting |
| Guangzhou Women and Children's medical center Coordinator of this site? Confirm its status | Guangzhou | China | Not yet recruiting |
| Nanfang Hospital, Southern Medical University Coordinator of this site? Confirm its status | Guangzhou | China | Not yet recruiting |
| The First Affiliated Hospital, Sun Yat-sen University Coordinator of this site? Confirm its status | Guangzhou | China | Not yet recruiting |
| The Affiliated Hospital of Guizhou Medical University Coordinator of this site? Confirm its status | Guiyang | China | Not yet recruiting |
| Anhui Medical University Second Affiliated Hospita Coordinator of this site? Confirm its status | Hefei | China | Not yet recruiting |
| Qilu Hospital of Shandong University Coordinator of this site? Confirm its status | Jinan | China | Not yet recruiting |
| Jiangxi Provincial Children's Hospital Coordinator of this site? Confirm its status | Nanchang | China | Not yet recruiting |
| Nanjing Children's Hospital Affiliated to Nanjing Medical University Coordinator of this site? Confirm its status | Nanjin | China | Not yet recruiting |
| Affiliated Hospital of Qingdao University Coordinator of this site? Confirm its status | Qingdao | China | Not yet recruiting |
| Children's Hospital Of Fudan University Coordinator of this site? Confirm its status | Shanghai | China | Not yet recruiting |
| Shanghai Children's Hospital Coordinator of this site? Confirm its status | Shanghai | China | Not yet recruiting |
| Shenzhen Children's Hospital Coordinator of this site? Confirm its status | Shenzhen | China | Not yet recruiting |
| Children's Hospital of Soochow University Coordinator of this site? Confirm its status | Suzhou | China | Not yet recruiting |
| Institute of Hematology and Blood Diseases Hospital, CAMS & PUMC Coordinator of this site? Confirm its status | Tianjin | China | Recruiting |
| Union Hospital of Tongji Medical College Huazhong University of Science and Technology Coordinator of this site? Confirm its status | Wuhan | China | Not yet recruiting |
| Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology Coordinator of this site? Confirm its status | Wuhan | China | Not yet recruiting |
| Wuhan Children's Hospital Coordinator of this site? Confirm its status | Wuhan | China | Not yet recruiting |
| Hong Kong Children's Hospital, The Chinese University of Hong Kong Coordinator of this site? Confirm its status | Hong Kong | Hong Kong | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.