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OncoMatch/Clinical Trials/NCT06882057

Newly-diagnosed Low Risk Pediatric B-cell ALL Protocol

Is NCT06882057 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2/3 trial studies multiple treatments including Blinatumomab and Reinduction-2 omission for acute lymphoblastic leukemia all.

Phase 2/3RecruitingInstitute of Hematology & Blood Diseases Hospital, ChinaNCT06882057Data as of Jun 2026Location: China · Hong Kong

Treatment: Blinatumomab · Reinduction-2 omission · Chemo-light Maintenance 2CCCG-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).

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Extracted eligibility criteria

Treatments studied

Immunotherapy

Blinatumomab

Other

Reinduction-2 omissionChemo-light Maintenance 2

Cancer type

Acute Lymphoblastic Leukemia

Biomarker criteria

Excluded: ABL1 fusion

Philadelphia chromosome positive ALL (Ph-ALL)

Excluded: IGHM surface IgM positive

sIgM+

Disease stage

Required: Stage LOW RISK GROUP

Excluded: Stage I/HR B-ALL GROUP

Low risk group; I/HR B-ALL group [excluded]

Demographics

Ages 1–18

Prior therapy

No prior treatment (treatment-naive required)
Max 0 prior lines

Cannot have received: glucocorticoid

Glucocorticoid treatment for ≥14 days within one month before enrollment

Cannot have received: ABL kinase inhibitor

ABL kinase inhibitors for > 7 days within one month before enrollment

Cannot have received: chemotherapy

Exception: except for emergency radiotherapy to relieve airway compression

any chemotherapy or radiotherapy within 3 months before enrollment (except for emergency radiotherapy to relieve airway compression)

Cannot have received: radiotherapy

Exception: except for emergency radiotherapy to relieve airway compression

any chemotherapy or radiotherapy within 3 months before enrollment (except for emergency radiotherapy to relieve airway compression)

Structured fields extracted by AI. May contain errors — verify against the official protocol.

Frequently asked questions

Is NCT06882057 currently recruiting?

Yes, this trial is currently recruiting patients.

Can patients have received prior systemic therapy?

No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.

Are patients with ABL1 alterations eligible?

No. ABL1 fusion is an exclusion criterion.

Are patients with IGHM alterations eligible?

No. IGHM surface IgM positive is an exclusion criterion.

What disease stage is eligible?

Stage LOW RISK GROUP is required.

Is there an age limit?

Yes. Patients must be 18 years or younger and at least 1 years old.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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