Risk-based treatment for infants newly diagnosed with lymphoid leukemia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 (However, steroid administration is allowable in oncologic emergencies only after the subject's disease diagnosis and risk group classification are completed.)
* Participants in other interventional studies other than this protocol

Where it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.