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
Institute of Hematology & Blood Diseases Hospital, China
3,000 participants
Mar 3, 2025
INTERVENTIONAL
Conditions
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-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).
Eligibility
Inclusion Criteria5
- 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 Criteria12
- 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)
Interventions
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). Additionally, second 14 days of blinatumomab will be given after completion of HDMTX consolidation treatment.
Reinduction-2 will be omitted for patients with NGS-MRD46\<10\^-6 who have receive the two courses of Blina-14.
Patients with FCM-MRD19\<0.01% and IgH rearrangement NGS MRD 46\<10\^-6 will receive chemo-light maintenance-2 with 4 cyles of 8-week course of MTX + 6MP (totally 32 weeks).
Locations(27)
View Full Details on ClinicalTrials.gov
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NCT06882057