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Newly-diagnosed Intermediate/High Risk Pediatric B-cell ALL Protocol

Study acronym: CCCG-I/HR-ALL
StatusRecruiting
PhasePhase 2/3
Started2025-01-03
View on ClinicalTrials.gov ↗

Amendment history

2026-07-21
Study Status, Oversight, Contacts/Locations v2
Study sites26→27
2025-02-04
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2025-01→confirmed 2025-01-03
Study sitesdetails revised at 26 of 26 sites
2025-01-01
Original filing
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.
Trial Details
NCT Number NCT06764238
Lead Sponsor Institute of Hematology & Blood Diseases Hospital, China
Conditions Acute Lymphoblastic Leukemia ALL, Childhood Leukemia, Acute Lymphoblastic, B Cell Acute Lymphoblastic Leukemia (B-ALL)
Enrollment 1,800 participants
Start Date 2025-01-03
Primary Completion 2029-12-31 (estimated)
Study Completion 2031-06 (estimated)
Updated on ClinicalTrials.gov 2026-07-23