OncoMatch/Clinical Trials/NCT06516679

Efficacy of Risk-Stratified Treatment in Newly Diagnosed Infant Leukemia

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

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.