Newly-diagnosed Intermediate/High Risk Pediatric B-cell ALL Protocol
Chinese Children's Cancer Group-2025 Protocol for Newly Diagnosed for Intermediate/High Risk Childhood B-cell ALL
Institute of Hematology & Blood Diseases Hospital, China
1,800 participants
Jan 3, 2025
INTERVENTIONAL
Conditions
Summary
Building upon the results from the CCCG-ALL-2015, CCCG-ALL-2020 multicenter study cohort, concurrent research findings, and the latest clinical trials, the CCCG-ALL-2025 I/HR-B-ALL is thus developed to further improve the event-free survival (EFS), and overall survival (OS), and quality of life (QoL) of children with intermediate- and high- risk B-cell childhood acute lymphoblastic leukaemia (I/HR-B-ALL), while decreasing adverse reactions and transplantation rates. This trial primarily aims to explore: 1. The efficacy of two randomized Blinatumomab application scheme on I/HR-ALL as determined by MRD negatvitiy rate. 2. The efficacy of modified mini-hyperCVD + Venetoclax in I/HR-ALL cannot afford blinatumomab, in contrast to historical control as determined by MRD negatvitiy rate.
Eligibility
Inclusion Criteria3
- Age older than 1 month to younger than 18 years.
- Diagnosis of acute lymphoblastic leukemia by bone marrow morphology.
- Diagnosis of B-ALL by immunophenotyping.
Exclusion Criteria9
- Low-risk ALL
- sIgM+
- Acute leukemias of ambiguous lineage diagnosed according to WHO or EGIL criteria.
- 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.
- Treated with glucocorticoids 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
For Group A I/HR-ALL patients after induction remission phase, continuous 28 days' blinatumomab followed by 3 cycles of high-dose methotrexate (HDMTX) will be applied, subsequently followed by interim continuation, late intensification, and maintenance therapy
For I/HR patients non eligible for blinatumomab randomization, venetoclax+ mini-hyperCVD will be applied after PVDL induction, subsequently followed by CAT as intensification, interim continuation, late intensification, and maintenance therapy
For Group B I/HR-ALL patients after induction remission phase: a two 14-day cycles of blinatumomab, alternating with three cycles of HDMTX will be applied, subsequently followed interim continuation, late intensification, and maintenance therapy
Locations(26)
View Full Details on ClinicalTrials.gov
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NCT06764238