CI

At a glance

ClinicalIndex Comparison Record
Phase 3Recruiting· 1,800 target
Drug / intervention
Blinatumomab (Group A) +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06764238
NCT06764238Phase 3RecruitingOn TrackUpdated 16mo ago
CompareCT.gov

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·interventional·Posted Jan 8, 2025·Updated Feb 7, 2025

In Brief

A Phase 3 clinical trial evaluating Blinatumomab (Group A), Venetoclax (nonRand Group), and 1 other intervention for Acute Lymphoblastic Leukemia ALL and 2 related conditions. Currently recruiting, targeting 1,800 participants across 26 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Lymphoblastic Leukemia ALL, Childhood Leukemia, Acute Lymphoblastic, B Cell Acute Lymphoblastic Leukemia (B-ALL)
CountriesChina, Hong Kong
Collaborators--

Timeline

Phase 3Recruiting
2025202620272028202920302031
First PostedJan 8, 2025
Enrollment StartJan 3, 2025
Primary CompletionDec 31, 2029
Study CompletionJun 1, 2031
TodayJul 1, 2026
Enrollment to primary: 5.0 yearsPosted 1.5 years agoPrimary completion in 3.5 years

Interventions

Blinatumomab (Group A)drug

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

Venetoclax (nonRand Group)drug

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

Blinatumomab (Group B)drug

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