Efficacy of Risk-Stratified Treatment in Newly Diagnosed Infant Leukemia

PHASE2RecruitingINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

December 11, 2024

Primary Completion Date

August 31, 2032

Study Completion Date

December 31, 2032

Conditions
Leukemia, Lymphoid
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 Cosolidation 3 chemotherapy(8wks) : Dexamethasone, Vincristine, Daunorubicin, Cytarabine, Cyclophosphamide, 6-mercaptopurine, intrathecal methotrexate~6. Maintenance chemotherapy(about 2yrs) : Vincristine, Dexamethasone, 6-mercaptopurine, intrathecal methotrexate"

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 methotrexate~5. High Risk Cosolidation 3 chemotherapy(8wks) : Dexamethasone, Vincristine, Daunorubicin, Cytarabine, Cyclophosphamide, 6-mercaptopurine, intrathecal methotrexate~6. Maintenance chemotherapy(about 2yrs) : Vincristine, Dexamethasone, 6-mercaptopurine, intrathecal methotrexate"

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 methotrexate~5. High Risk Cosolidation 3 chemotherapy(8wks) : Dexamethasone, Vincristine, Daunorubicin, Cytarabine, Cyclophosphamide, 6-mercaptopurine, intrathecal methotrexate~6. Allogeneic hematopoietic stem cell transplantation"

Trial Locations (8)

Unknown

RECRUITING

Chonnam National University Hwasun Hospital, Hwasun

RECRUITING

Jeju National University Hospital, Jeju City

RECRUITING

Pusan National University Yangsan Hospital, Pusan

RECRUITING

Asan Medical Center, Seoul

RECRUITING

Samsung Medical Cente, Seoul

RECRUITING

Seoul National University Hospital, Seoul

RECRUITING

Seoul saint Mary's Hospital, Seoul

RECRUITING

Severance Hospital, Seoul

All Listed Sponsors
lead

Yonsei University

OTHER