Efficacy of Risk-Stratified Treatment in Newly Diagnosed Infant Leukemia

Официальное название

Efficacy of Risk-Stratified Treatment in Newly Diagnosed Infant Leukemia: A Multicenter, Prospective Study

Обзор

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.

Подробное описание

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

Вмешательства

• Препарат 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
• Препарат 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
• Препарат 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

Первичные конечные точки

• 3-years Overall survival(OS) rate [Срок оценки: 3-years]

Вторичные конечные точки (5)

• Overall survival (OS) [Срок оценки: Up to 5years]
• Event Free Survial(EFS) [Срок оценки: 3-years and 5-years]
• The rate of hematopoietic stem cell transplant patients by risk group [Срок оценки: Up to 5years]
• recurred rate [Срок оценки: Up to 5years]
• Death rate related to infusion [Срок оценки: Up to 5years]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

South Korea · 10 центров

• 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
• … и ещё 2 центра

Идентификаторы

NCT: NCT06516679 · 4-2023-1263

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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