About this trial

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

Qualifiers

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

Disqualifiers

T-ALL

I/HR B-ALL group

sIgM+

Acute leukemias of ambiguous lineage diagnosed according to WHO or EGIL criteria.

Trial design

Treatments tested in this trial

  • Blinatumomab
  • Reinduction-2 omission
  • Chemo-light Maintenance 2

Treatment groups

3,000 Participants
are divided into 3 treatment groups

Locations

27
China
Anhui Medical University Second Affiliated Hospital HefeiAnhui, China
Anhui Provincial Children's Hospital HefeiAnhui, China
Chongqing Medical University Affiliated Children's Hospital ChongqingChongqing Municipality, China
Fujian Medical University Union Hospital FuzhouFujian, China

Sponsors and collaborators

Institute of Hematology & Blood Diseases Hospital, China

Lead sponsor