Clinical trial · Interventional
Efficacy of Risk-Stratified Treatment in Newly Diagnosed Infant Leukemia
Efficacy of Risk-Stratified Treatment in Newly Diagnosed Infant Leukemia: A Multicenter, Prospective Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leukemia, Lymphoid | Lymphoid Leukemia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Allogeneic hematopoietic stem cell transplantation after Consolidation #4(with daunorubicin) | Drug | — | UNRESOLVED |
| Consolidation #4(with daunorubicin) | Drug | — | UNRESOLVED |
| Consolidation #4(without daunorubicin) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Low risk group
- description
- KMT2A wild type \& minimal residual disease(MRD) (-) after consolidation 1
- interventionNames
- Drug: Consolidation #4(without daunorubicin)
- type
- EXPERIMENTAL
- label
- Intermediate risk group
- description
- ntermediate risk (If one of the two cases below applies) * KMT2A: MLL mutation (+) \& minimal residual disease (MRD) (-) after consolidation 1 * KMT2A: wild type \& minimal residual disease (MRD) (+) after consolidation 1
- interventionNames
- Drug: Consolidation #4(with daunorubicin)
- type
- EXPERIMENTAL
- label
- High risk group
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 2 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available