Risk-based treatment for infants newly diagnosed with lymphoid leukemia
Efficacy of Risk-Stratified Treatment in Newly Diagnosed Infant Leukemia: A Multicenter, Prospective Study
This trial will try different chemotherapy plans and, for some infants, stem cell transplant based on genetic markers and MRD to find the best approach for babies under 1 year with lymphoid leukemia.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | N/A to 2 Years |
| Sex | All |
| Sponsor | Yonsei University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 8 sites (Hwasun and 7 other locations) |
| Trial ID | NCT06516679 on ClinicalTrials.gov |
What this trial studies
This is an open-label, multicenter, prospective phase 2 trial that stratifies infants with lymphoid leukemia into low, intermediate, or high risk groups using genetic features at diagnosis and minimal residual disease (MRD) measurements after treatment. Low- and intermediate-risk infants receive induction followed by risk-appropriate consolidation and maintenance chemotherapy, while high-risk infants are routed to hematopoietic stem cell transplant after consolidation that includes daunorubicin. Consolidation #4 is given with or without daunorubicin depending on the assigned arm, and transplant is reserved for the predefined high-risk pathway. The study also prospectively collects treatment-related side effects and long-term outcome data to clarify transplant indications and late effects in this population.
Who should consider this trial
Good fit: Infants diagnosed before their first birthday with ALL or lymphoid-predominant acute leukemia who have not relapsed and whose parents provide informed consent are the intended participants.
Not a fit: Patients with mature B‑cell/Burkitt leukemia, known bone marrow failure syndromes (e.g., Down syndrome, Fanconi anemia), prior hematopoietic stem cell transplant, relapsed disease, recent systemic steroids, or other contraindications are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, this approach could improve survival and help doctors identify which infants truly need stem cell transplant while reducing unnecessary exposure to intensive therapy.
How similar studies have performed: Risk-adapted and MRD‑guided treatment strategies have shown promise in pediatric leukemia broadly, but the specific role of transplant in infant lymphoid leukemia remains uncertain and under study.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * The age of diagnosis is less than 1 year old * The disgnosisi of ALL or ALAL(lymphoid predominant) * Informed consent of the parents(guardians) before participation in this study Exclusion Criteria: * Burkitt leukemia/lymphoma or mature B-cell leukemia * Down syndrome, Bloom syndrome, ataxia-telangiectasia, Fanconi anemia, Kostmann syndrome, Shwachman syndrome or other bone marrow failure syndrome, hematopoietic stem cell transplantation * Relapsed infant leukemia * Participants with contraindication to medication * Administered systemic steroid therapy within 4 weeks prior to this study * Participants in other interventional studies other than this protocol
Where this trial is running
Hwasun and 7 other locations
- Chonnam National University Hwasun Hospital — Hwasun, South Korea (Recruiting)
- Jeju National University Hospital — Jeju City, South Korea (Recruiting)
- Pusan National University Yangsan Hospital — Pusan, South Korea (Recruiting)
- Asan Medical Center — Seoul, South Korea (Recruiting)
- Samsung Medical Cente — Seoul, South Korea (Recruiting)
- Seoul National University Hospital — Seoul, South Korea (Recruiting)
- Seoul saint Mary's Hospital — Seoul, South Korea (Recruiting)
- Severance Hospital — Seoul, South Korea (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.