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.
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.
Low-risk ALL
sIgM+
Acute leukemias of ambiguous lineage diagnosed according to WHO or EGIL criteria.
ALL evolved from chronic myeloid leukemia (CML).
Institute of Hematology & Blood Diseases Hospital, China
Lead sponsor