OncoMatch

OncoMatch/Clinical Trials/NCT06184009

Treatment of Newly Diagnosed High Risk Pediatric Acute Lymphoblastic Leukemia

Is NCT06184009 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies ALL, High risk for pediatric acute lymphoblastic leukemia.

Phase 2RecruitingJae Wook LeeNCT06184009Data as of Jun 2026Location: South Korea

Treatment: ALL, High risk* Clinical and genetic factors consistent with High risk : Induction → Consolidation 1. BM MRD \&lt; 0.01% : IM #1 → DI #1 → IM #2 → Maintenance 2. BM MRD ≥ 0.01% : IM #1 → DI #1 → IM #2 → DI #2 → Maintenance 3. BM MRD ≥ 0.01% after Consolidation <!-- --> 1. T cell ALL : Change to very high risk regimen 2. Pre-B ALL : IM #1 → Intensification 1. BM MRD \&lt; 0.01% after IM #1 : DI #1 → IM #2 → DI #2 → Maintenance 2. BM MRD ≥ 0.01% after IM #1 : Change to Very high risk regimen * Difference in the number of \&#39;interim maintenance(IM)\&#39; and \&#39;delayed intensification(DI)\&#39; is important for chemotherapies based on MRD.

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Extracted eligibility criteria

Treatments studied

Other

ALL, High risk

Cancer type

Acute Lymphoblastic Leukemia

Biomarker criteria

Required: KMT2A (MLL) rearrangement

Demographics

Ages 1–19

Prior therapy

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

Cannot have received: steroid

Exception: as specified in the above selection criteria

Patients who have already received steroid treatment for newly diagnosed ALL specified in the above selection criteria

Cannot have received: chemotherapy (intrathecal cytarabine)

Exception: more than one dose

chemotherapies more than one intrathecal cytarabine treatment

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

Frequently asked questions

Is NCT06184009 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.

Does this trial require KMT2A?

Yes, KMT2A rearrangement is a required biomarker for enrollment.

Is there an age limit?

Yes. Patients must be 19 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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