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OncoMatch/Clinical Trials/NCT06516679

Efficacy of Risk-Stratified Treatment in Newly Diagnosed Infant Leukemia

Is NCT06516679 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies multiple treatments including Consolidation #4(without daunorubicin) and Consolidation #4(with daunorubicin) for leukemia, lymphoid.

Phase 2RecruitingYonsei UniversityNCT06516679Data as of Jun 2026Location: South Korea

Treatment: Consolidation #4(without daunorubicin) · Consolidation #4(with daunorubicin) · Allogeneic hematopoietic stem cell transplantation after Consolidation #4(with daunorubicin)This clinical trial is an open-label, multicenter, prospective phase 2 clinical trial targeting pediatric leukemia patients of infant age. The goal is to improve survival rates by varying the presence or absence of chemotherapy and hematopoietic stem cell transplantation based on genetic characteristics at the time of diagnosis and minimal residual disease (MRD) values measured by various methods after treatment. In addition, by clearly defining the patient group that requires hematopoietic stem cell transplantation, it is expected that the role of hematopoietic stem cell transplantation in infantile leukemia, for which there have been various guidelines for hematopoietic stem cell transplantation, can be confirmed. Additionally, due to the characteristics of infants, this study aim to identify long-term sequelae or prognosis related to treatment by prospectively collecting side effect data related to treatment during and after treatment.

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Extracted eligibility criteria

Treatments studied

Other

Consolidation #4(without daunorubicin)Consolidation #4(with daunorubicin)Allogeneic hematopoietic stem cell transplantation after Consolidation #4(with daunorubicin)

Cancer type

Acute Lymphoblastic Leukemia

Chronic Lymphocytic Leukemia

Demographics

Ages 0–2

Prior therapy

No prior treatment (treatment-naive required)

Cannot have received: systemic steroid therapy

Administered systemic steroid therapy within 4 weeks prior to this study

Cannot have received: hematopoietic stem cell transplantation

hematopoietic stem cell transplantation

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

Frequently asked questions

Is NCT06516679 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.

Is there an age limit?

Yes. Patients must be 2 years or younger and at least 0 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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