NCT06882057 Newly-diagnosed Low Risk Pediatric B-cell ALL Protocol
| NCT ID | NCT06882057 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | Institute of Hematology & Blood Diseases Hospital, China |
| Condition | Acute Lymphoblastic Leukemia ALL |
| Study Type | INTERVENTIONAL |
| Enrollment | 3,000 participants |
| Start Date | 2025-03-03 |
| 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 3,000 participants in total. It began in 2025-03-03 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
CCCG-ALL2025 LR-B-ALL plan is designed based on the CCCG-ALL2020 plan. This is a clinical trial using 14 days of blinatumomab (Blina-14) as early intensification after induction therapy and 2nd Blina-14 in consolidation therapy in all newly diagnosed provisional low-risk (LR) pediatric acute lymphoblastic leukemia (ALL) patients, regardless of measurable residual diseases (MRD) status. We will compare the efficacy of chemotherapy combined with Blina-14, comparing to CAT+ intensification or historical regimens. Patients with early remission in depth will receive chemo-light late intensification and maintenance therapy afterwards. Early complete remission in depth and maintenance reduction will be determined by next-generation sequencing (Ig-NGS MRD).
Eligibility Criteria
Inclusion Criteria: Must meet all items below: 1. Age older than 1 year and younger than 18 years. 2. Diagnosis of acute lymphoblastic leukemia by bone marrow morphology. 3. Diagnosis of B-ALL by immunophenotyping. 4. Low risk group Exclusion Criteria: Should be excluded in the presence of any item below: 1. T-ALL 2. I/HR B-ALL group 3. sIgM+ 4. Acute leukemias of ambiguous lineage diagnosed according to WHO or EGIL criteria. 5. Philadelphia chromosome positive ALL (Ph-ALL) 6. ALL evolved from chronic myeloid leukemia (CML). 7. Down's syndrome, or major congenital or hereditary disease with organ dysfunction 8. Secondary leukemia 9. Known underlying congenital immunodeficiency or metabolic disease 10. Congenital heart disease with cardiac insufficiency. 11. Glucocorticoid treatment 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 NCT06882057 clinical trial?
This trial is open to participants of all sexes, aged 1 Year 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 NCT06882057 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 NCT06882057 currently recruiting?
Yes, NCT06882057 is actively recruiting participants. Contact the research team at xfzhu@ihcams.ac.cn for enrollment information.
Where is the NCT06882057 trial being conducted?
This trial is being conducted at Hefei, China, Hefei, China, Chongqing, China, Fuzhou, China and 11 additional locations.
Who is sponsoring the NCT06882057 clinical trial?
NCT06882057 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 3,000 participants.
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