OncoMatch/Clinical Trials/NCT06764238

Newly-diagnosed Intermediate/High Risk Pediatric B-cell ALL Protocol

Is NCT06764238 recruiting? Yes, currently enrolling (May 2026). This Phase 2/3 trial studies multiple treatments including Blinatumomab (Group A) and Venetoclax (nonRand Group) for acute lymphoblastic leukemia all.

Phase 2/3RecruitingInstitute of Hematology & Blood Diseases Hospital, ChinaNCT06764238Data as of May 2026

Treatment: Blinatumomab (Group A) · Venetoclax (nonRand Group) · Blinatumomab (Group B) — Building upon the results from the CCCG-ALL-2015, CCCG-ALL-2020 multicenter study cohort, concurrent research findings, and the latest clinical trials, the CCCG-ALL-2025 I/HR-B-ALL is thus developed to further improve the event-free survival (EFS), and overall survival (OS), and quality of life (QoL) of children with intermediate- and high- risk B-cell childhood acute lymphoblastic leukaemia (I/HR-B-ALL), while decreasing adverse reactions and transplantation rates. This trial primarily aims to explore: 1. The efficacy of two randomized Blinatumomab application scheme on I/HR-ALL as determined by MRD negatvitiy rate. 2. The efficacy of modified mini-hyperCVD + Venetoclax in I/HR-ALL cannot afford blinatumomab, in contrast to historical control as determined by MRD negatvitiy rate.

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Extracted eligibility criteria

Cancer type

Acute Lymphoblastic Leukemia

Disease stage

Required: Stage INTERMEDIATE RISK, HIGH RISK

Excluded: Stage LOW-RISK

Newly-diagnosed Intermediate/High Risk Pediatric B-cell ALL Protocol; Low-risk ALL [excluded]

Prior therapy

No prior treatment (treatment-naive required)

Max 0 prior lines

Cannot have received: glucocorticoid

Treated with glucocorticoids 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

any chemotherapy within 3 months before enrollment

Cannot have received: radiotherapy

Exception: emergency radiotherapy to relieve airway compression

any 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.

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