About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Consolidation #4(without daunorubicin)
- Consolidation #4(with daunorubicin)
- Allogeneic hematopoietic stem cell transplantation after Consolidation #4(with daunorubicin)