Tests blinatumomab and venetoclax in children with intermediate or high risk B-cell leukemia
Tests blinatumomab schedules and venetoclax in children with newly diagnosed B-cell acute lymphoblastic leukemia.
Key facts
- Who runs it
- Institute of Hematology & Blood Diseases Hospital, China
- Where
- Hong Kong, Hong KongSee the siteAlso in 1 other country, 26 sites
- Trial code
- Registry title
- Newly-diagnosed Intermediate/High Risk Pediatric B-cell ALL Protocol
- Status
- Recruiting
- Phase
- Phase 2/3
- People taking part
- 1,800 people, planned
- Started
- 3 Jan 2025
- Expected to end
- Jun 2031
- Type of study
- Interventional, 3 groups
- Treatments tested
- Blinatumomab (Group A)
- Venetoclax (nonRand Group)
- Blinatumomab (Group B)
- Record updated
- 23 July 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for children with newly diagnosed B-cell acute lymphoblastic leukaemia (B-ALL) at intermediate or high risk. It tests blinatumomab schemes and a venetoclax-based regimen.
- Age
- Older than 1 month and younger than 18 years.
- Sex
- All sexes can join.
- Disease stage
- Newly diagnosed B-cell acute lymphoblastic leukaemia (ALL), confirmed by bone marrow and immunophenotyping. Intermediate or high risk; low-risk ALL cannot join.
- Earlier treatment
- Cannot join if, within 1 month before enrollment, treated with glucocorticoids for 14 days or more, or ABL kinase inhibitors for more than 7 days. Cannot join if any chemotherapy or radiotherapy in the 3 months before enrollment (except emergency radiotherapy to relieve airway compression).
- Biomarker or test result
- B-ALL confirmed by immunophenotyping. sIgM+ disease cannot join.
Main reasons for not taking part
- Low-risk ALL
- sIgM+
- Acute leukaemia of ambiguous lineage, ALL evolved from chronic myeloid leukaemia (CML), or secondary leukaemia
- Down's syndrome, or major congenital or hereditary disease with organ dysfunction
- Known congenital immunodeficiency or metabolic disease, or congenital heart disease with cardiac insufficiency
The registry criteria, word for word
Show all 12 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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)
- Down's syndrome, or major congenital or hereditary disease with organ dysfunction
- Known underlying congenital immunodeficiency or metabolic disease
- Congenital heart disease with cardiac insufficiency
- Low-risk ALL
- sIgM+
- Acute leukemias of ambiguous lineage diagnosed according to WHO or EGIL criteria
- ALL evolved from chronic myeloid leukemia (CML)
- Secondary leukemia
Where in Hong Kong
Also in 1 other country, 26 sites
- Hong Kong Children's HospitalHong Kong, Hong KongContact: Chi-kong Li, MDNot yet recruiting
About the trial
What the trial wants to find out
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:
Read full original descriptionShow less
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.
The 3 groups in the trial
- Group ATreatment being tested
After PVDL+CAT induction remission phase, patients randomized to Group A will be subjected to consolidation phase with continuous 28 days' blinatumomab followed by 3 cycles of high-dose methotrexate (HDMTX)
Treatment: Blinatumomab (Group A)
- Group BTreatment being tested
After PVDL+CAT induction remission phase, patients randomized to Group B will be subjected to consolidation phase with two 14-day cycles of blinatumomab, alternating with 3 cycles of high-dose methotrexate (HDMTX).
Treatment: Blinatumomab (Group B)
- NonRandonmized GroupTreatment being tested
Patients who will not be subjected to blinatomomab randomization, will received PVDL + Venetoclax + mini-hyperCVD as induction phase , subsequently receiving CAT as early intensification.
Treatment: Venetoclax (nonRand Group)
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Chinese Children's Cancer Group-2025 Protocol for Newly Diagnosed for Intermediate/High Risk Childhood B-cell ALL
- Plain-language title
- Tests blinatumomab and venetoclax in children with intermediate or high risk B-cell leukemiaGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 23 July 2026