Newly-diagnosed Low Risk Pediatric B-cell ALL Protocol

Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age1-18
SponsorInstitute of Hematology & Blood Diseases Hospital, China

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