Efficacy of Risk-Stratified Treatment in Newly Diagnosed Infant Leukemia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Consolidation #4(without daunorubicin), Consolidation #4(with daunorubicin), Allogeneic hematopoietic stem cell transplantation after Consolidation #4(with daunorubicin).
- Who it may be relevant to
- Registry conditions: Leukemia, Lymphoid. Basic parameters: up to 2 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Efficacy of Risk-Stratified Treatment in Newly Diagnosed Infant Leukemia: A Multicenter, Prospective Study
Overview
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.
Detailed description
Infant leukemia patients are classified into low/intermediate/high risk groups and hematopoietic stem cell transplantation is performed after chemotherapy or chemotherapy as shown in the schema below.
* Low risk group : Induction chemotherapy-Low Risk Consolidation chemotherapy 1\~4 - Maintenance chemotherapy * Intermediate risk group : Induction chemotherapy-High Risk Consolidation chemotherapy 1\~4 - Maintenance chemotherapy * High risk group : Induction chemotherapy-High Risk Consolidation chemotherapy 1\~4 - hematopoietic stem cell transplantation
Interventions
- Drug Consolidation #4(without daunorubicin)
1. Induction chemotherapy(5wks) : Prednisolone, Dexamethasone, Vincristine, Daunorubicin, L-asparaginase, Cytarabine, intrathecal cytarabine, intrathecal methotrexate 2. Low Risk Cosolidation 1 chemotherapy(3wks) : Cytarabine, Etoposide, Cyclophosphamide, intrathecal methotrexate 3. Low Risk Cosolidation 2 chemotherapy(3wks) : Methotrexate, 6-mercaptopurine, intrathecal methotrexate 4. Low Risk Cosolidation 3 chemotherapy(3wks) : Cytarabine, L-asparaginase, intrathecal methotrexate 5. Low Risk C - Drug Consolidation #4(with daunorubicin)
1. Induction chemotherapy(5wks) : Prednisolone, Dexamethasone, Vincristine, Daunorubicin, L-asparaginase, Cytarabine, intrathecal cytarabine, intrathecal methotrexate 2. High Risk Cosolidation 1 chemotherapy(3wks) : Cytarabine, Etoposide, Cyclophosphamide, Daunorubicin intrathecal methotrexate 3. High Risk Cosolidation 2 chemotherapy(3wks) : Methotrexate, 6-mercaptopurine, intrathecal methotrexate 4. High Risk Cosolidation 3 chemotherapy(3wks) : Cytarabine, L-asparaginase, intrathecal methotrexa - Drug Allogeneic hematopoietic stem cell transplantation after Consolidation #4(with daunorubicin)
1. Induction chemotherapy(5wks) : Prednisolone, Dexamethasone, Vincristine, Daunorubicin, L-asparaginase, Cytarabine, intrathecal cytarabine, intrathecal methotrexate 2. High Risk Cosolidation 1 chemotherapy(3wks) : Cytarabine, Etoposide, Cyclophosphamide, Daunorubicin intrathecal methotrexate 3. High Risk Cosolidation 2 chemotherapy(3wks) : Methotrexate, 6-mercaptopurine, intrathecal methotrexate 4. High Risk Cosolidation 3 chemotherapy(3wks) : Cytarabine, L-asparaginase, intrathecal methotrexa
Primary outcome measures
- 3-years Overall survival(OS) rate [Time frame: 3-years]
Secondary outcome measures (5)
- Overall survival (OS) [Time frame: Up to 5years]
- Event Free Survial(EFS) [Time frame: 3-years and 5-years]
- The rate of hematopoietic stem cell transplant patients by risk group [Time frame: Up to 5years]
- recurred rate [Time frame: Up to 5years]
- Death rate related to infusion [Time frame: Up to 5years]
Eligibility 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 (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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
South Korea · 10 centers
- Kyungpook National University Chilgok-Hospital — Daegu
- Chungnam National University Hospital — Daejeon
- Chonnam National University Hwasun Hospital — Hwasun
- Jeju National University Hospital — Jeju City
- Pusan National University Yangsan Hospital — Pusan
- Asan Medical Center — Seoul
- Samsung Medical Cente — Seoul
- Seoul National University Hospital — Seoul
- … and 2 more centers
Identifiers
NCT: NCT06516679 · 4-2023-1263