NCT06607419 Efficacy Study of Blinatumomab Clean Up Early Residual Disease for Newly Diagnosed Pediatric B Lymphoblastic Leukemia
| NCT ID | NCT06607419 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | Shanghai Jiao Tong University School of Medicine |
| Condition | B-Cell Lymphoblastic Leukemia |
| Study Type | INTERVENTIONAL |
| Enrollment | 90 participants |
| Start Date | 2024-05-21 |
| Primary Completion | 2025-05-31 |
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 90 participants in total. It began in 2024-05-21 with a primary completion date of 2025-05-31.
⚠ 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
The goal of this clinical trial is to evaluate the efficacy of Blinatumomab in pediatric patient with newly diagnosed acute B-Lymphoblastic leukemia with poor response to early chemotherapy, i.e. day 19 MRD ≥ 0.1% (low-risk) or day 19 MRD ≥ 0.01% (intermediate-risk). The main question is: • If the flow cytometric MRD negative (\<0.01%) rate and the NGS- MRD negative (\<0.0001%) rate at the end of induction for patients received Blinatumomab will be superior to historical control (D46MRD in the CCCG-ALL2020 protocol). Participants will: * Take 14 days full dose Blinatumomab; * With bone marrow evaluated before and after Blinatumomab treatment.
Eligibility Criteria
Inclusion Criteria: * Age older than 1 month to younger than 18 years. * Diagnosis of acute lymphoblastic leukemia by bone marrow morphology. * Immunophenotyping: acute B-lymphoblastic leukemia; * Meet one of the following situations: A. Provisional low-risk: D19MRD ≥ 0.1%; B. Provisional intermediate-risk: D19MRD ≥ 0.01%; * Subjects in the sytudy group or their guardians must be able to understand and accept the informed consent approved by the Ethics Committee Exclusion Criteria: * sIgM+; * ALL evolved from chronic myeloid leukemia (CML); * Down's syndrome, or major congenital or hereditary disease with organ dysfunction; * Other secondary leukemias; * CNS involvement; * History of epilepsy; or convulsions within the last month; * Known underlying congenital immunodeficiency or metabolic disease; * Congenital heart disease with cardiac insufficiency; * 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); * Initial diagnosis of high risk; * D46MRD ≥1%.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06607419 clinical trial?
This trial is open to participants of all sexes, aged 1 Month or older, up to 18 Years, studying B-Cell Lymphoblastic Leukemia. 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 NCT06607419 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 NCT06607419 currently recruiting?
Yes, NCT06607419 is actively recruiting participants. Contact the research team at shenshuhong@scmc.com.cn for enrollment information.
Where is the NCT06607419 trial being conducted?
This trial is being conducted at Hefei, China, Fuzhou, China, Shanghai, China, Ningbo, China.
Who is sponsoring the NCT06607419 clinical trial?
NCT06607419 is sponsored by Shanghai Jiao Tong University School of Medicine. The trial plans to enroll 90 participants.
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