NCT06882057RecruitingPhase 2/3
Newly-diagnosed Low Risk Pediatric B-cell ALL Protocol
Chinese Children's Cancer Group-2025 Protocol for Newly Diagnosed Low Risk Childhood B-cell Acute Lymphoblastic Leukemia
Source: ClinicalTrials.gov · Last updated 26 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
CCCG-ALL2025 LR-B-ALL plan is designed based on the CCCG-ALL2020 plan. This is a clinical trial using 14 days of blinatumomab (Blina-14) as early intensification after induction therapy and 2nd Blina-14 in consolidation therapy in all newly diagnosed provisional low-risk (LR) pediatric acute lymphoblastic leukemia (ALL) patients, regardless of measurable residual diseases (MRD) status. We will compare the efficacy of chemotherapy combined with Blina-14, comparing to CAT+ intensification or historical regimens. Patients with early remission in depth will receive chemo-light late intensification and maintenance therapy afterwards. Early complete remission in depth and maintenance reduction will be determined by next-generation sequencing (Ig-NGS MRD).
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2/3
- Study type
- Interventional
- Enrollment
- 3000 (estimated)
- First submitted
- 11 Mar 2025
- Start date
- 3 Mar 2025
- Primary completion date
- 31 Dec 2029
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, China
- NCT number
- NCT06882057
What you commit to
- Study type: Interventional · Phase 2/3
- Planned participants: 3000
- From 3 Mar 2025 to the primary completion date, 31 Dec 2029
- 27 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
- Glucocorticoid treatment 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)
Other illness
- Down's syndrome, or major congenital or hereditary disease with organ dysfunction
- Known underlying congenital immunodeficiency or metabolic disease
- Congenital heart disease with cardiac insufficiency.
Other
- Should be excluded in the presence of any item below:
- T-ALL
- I/HR B-ALL group
- sIgM+
- Acute leukemias of ambiguous lineage diagnosed according to WHO or EGIL criteria.
- Philadelphia chromosome positive ALL (Ph-ALL)
- ALL evolved from chronic myeloid leukemia (CML).
- Secondary leukemia
Who the study is looking for
- Must meet all items below:
- Age older than 1 year and younger than 18 years.
- Diagnosis of acute lymphoblastic leukemia by bone marrow morphology.
- Diagnosis of B-ALL by immunophenotyping.
- Low risk group
Age in the registry: 1 year to 18 years · Sex: All · Does not accept healthy volunteers
Sites (27)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Xiangya Hospital 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 |
| The Third Xiangya Hospital of the Central South University Coordinator of this site? Confirm its status | Changsha | China | Not yet recruiting |
| West China Second University Hospital 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 |
| Nanfang Hospital, Southern Medical University Coordinator of this site? Confirm its status | Guangzhou | China | Not yet recruiting |
| Guangzhou Women and Children's medical center 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 Provincial Children's Hospital Coordinator of this site? Confirm its status | Hefei | China | Not yet recruiting |
| Anhui Medical University Second Affiliated Hospital 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 | Nanjing | China | Not yet recruiting |
| The People's Hospital of Guangxi Zhuang Autonomous Region Coordinator of this site? Confirm its status | Nanning | China | Not yet recruiting |
| Affiliated Hospital of Qingdao University Coordinator of this site? Confirm its status | Qingdao | China | Not yet recruiting |
| Shanghai Children's Hospital Coordinator of this site? Confirm its status | Shanghai | 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 Medical Cener, Shanghai Jiao Tong University School of Medicine Coordinator of this site? Confirm its status | Shanghai | China | Not yet recruiting |
| Shenzhen Children's Hospita 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 |
| 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 |
| Union Hospital of Tongji Medical College Huazhong University of Science and Technology Coordinator of this site? Confirm its status | Wuhan | China | Not yet recruiting |
| Xi'an Northwest Women and Children Hospital Coordinator of this site? Confirm its status | Xi’an | China | Not yet recruiting |
| Hong Kong Children's Hospital 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.