Blinatumomab Treatment Trial for Newly Diagnosed Low-Risk Childhood Leukemia
Tests blinatumomab with chemotherapy in children newly diagnosed with low-risk B-cell leukemia.
Plain-language title generated from the registry record
Registry title: Newly-diagnosed Low Risk Pediatric B-cell ALL Protocol
Key facts
- Where
- Hong Kong, Hong KongSee the site
- Phase
- Phase 2/3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 1 and 18 years old?
Source: NCT06882057, who can take part
Where in Hong Kong
- Hong Kong Children's HospitalHong Kong, Hong KongNot yet recruiting
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?
Trial details
- Who runs it
- Institute of Hematology & Blood Diseases Hospital, China
- Trial code
- NCT06882057
- Record updated
- 26 August 2025
- Original description
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).Read full original descriptionShow less
Chinese Children's Cancer Group-2025 Protocol for Newly Diagnosed Low Risk Childhood B-cell Acute Lymphoblastic Leukemia
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).
Inclusion: Must meet all items below:; Age older than 1 year and younger than 18 years; Diagnosis of acute lymphoblastic leukemia by bone marrow morphology; Diagnosis of B-ALL by immunophenotyping; Low risk group.
Exclusion: 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); 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; Should be excluded in the presence of any item below:; T-ALL; I/HR B-ALL group; sIgM+; Acute leukemias of ambiguous lineage diagnosed according to WHO or EGIL criteria; Philadelphia chromosome positive ALL (Ph-ALL); ALL evolved from chronic myeloid leukemia (CML); Secondary leukemia.