NCT06764238 Newly-diagnosed Intermediate/High Risk Pediatric B-cell ALL Protocol
| NCT ID | NCT06764238 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | Institute of Hematology & Blood Diseases Hospital, China |
| Condition | Acute Lymphoblastic Leukemia ALL |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,800 participants |
| Start Date | 2025-01-03 |
| Primary Completion | 2029-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 1,800 participants in total. It began in 2025-01-03 with a primary completion date of 2029-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: 1. Age older than 1 month to younger than 18 years. 2. Diagnosis of acute lymphoblastic leukemia by bone marrow morphology. 3. Diagnosis of B-ALL by immunophenotyping. Exclusion Criteria: 1. Low-risk ALL 2. sIgM+ 3. Acute leukemias of ambiguous lineage diagnosed according to WHO or EGIL criteria. 4. ALL evolved from chronic myeloid leukemia (CML). 5. Down's syndrome, or major congenital or hereditary disease with organ dysfunction 6. Secondary leukemia 7. Known underlying congenital immunodeficiency or metabolic disease 8. Congenital heart disease with cardiac insufficiency. 9. 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)
Contact & Investigator
Xiaofan Zhu, MD
PRINCIPAL INVESTIGATOR
Institute of Hematology and Blood Diseases Hospital, CAMS & PUMC
Frequently Asked Questions
Who can join the NCT06764238 clinical trial?
This trial is open to participants of all sexes, aged 1 Month or older, up to 18 Years, studying Acute Lymphoblastic Leukemia ALL. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06764238 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06764238 currently recruiting?
Yes, NCT06764238 is actively recruiting participants. Contact the research team at zhangjingliao@ihcams.ac.cn for enrollment information.
Where is the NCT06764238 trial being conducted?
This trial is being conducted at Hefei, China, Hefei, China, Fuzhou, China, Guangzhou, China and 11 additional locations.
Who is sponsoring the NCT06764238 clinical trial?
NCT06764238 is sponsored by Institute of Hematology & Blood Diseases Hospital, China. The principal investigator is Xiaofan Zhu, MD at Institute of Hematology and Blood Diseases Hospital, CAMS & PUMC. The trial plans to enroll 1,800 participants.
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