Status:
RECRUITING
Newly-diagnosed Low Risk Pediatric B-cell ALL Protocol
Lead Sponsor:
Institute of Hematology & Blood Diseases Hospital, China
Conditions:
Acute Lymphoblastic Leukemia ALL
Childhood Leukemia, Acute Lymphoblastic
Eligibility:
All Genders
1-18 years
Phase:
PHASE2
PHASE3
Brief Summary
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-...
Detailed Description
1. All LR-B-ALL patients will be treated with 14 days of blinatumomab (Blina-14) as early intensification to replace CAT+ (historically given in LR-B-AL with MRD19\>0.1% in the 2020 protocol). 2. Two ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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).
- Down's syndrome, or major congenital or hereditary disease with organ dysfunction
- Secondary leukemia
- Known underlying congenital immunodeficiency or metabolic disease
- Congenital heart disease with cardiac insufficiency.
- 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)
Key Trial Info
Start Date :
March 3 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2033
Estimated Enrollment :
3000 Patients enrolled
Trial Details
Trial ID
NCT06882057
Start Date
March 3 2025
End Date
June 1 2033
Last Update
August 26 2025
Active Locations (27)
Enter a location and click search to find clinical trials sorted by distance.
1
Anhui Medical University Second Affiliated Hospital
Hefei, Anhui, China
2
Anhui Provincial Children's Hospital
Hefei, Anhui, China
3
Chongqing Medical University Affiliated Children's Hospital
Chongqing, Chongqing Municipality, China
4
Fujian Medical University Union Hospital
Fuzhou, Fujian, China