Acute Myeloid Leukemia
Conditions
Interventions
All registered patients will recieve two common induction chemotherapies.
Induction-1A (ECM): standard dose Ara-C, mitoxantrone (MIT), etoposide (VP-16), and triple intrathecal therapy [TIT
Ara-C, methotrexate (MTX), and hydrocortisone (HDC)].
Induction-2A (HCEI): high-dose Ara-C, idarubicin (IDA), VP-16, and TIT.
All patients who achieved hematological CR will be allocated to one of th
non-CBF-AML without high-risk cytogenetics and MRD=0.1% after Induciton-1
AML with high-risk cytogenetics
non-CR after Induction-1
(1) LR
Patients will receive Consolidation-1(HCM
high-dose Ara-C, MIT, TIT), Consolidation-2(HCI
high-dose Ara-C, IDA, TIT), and Consolidation-3(HC
high-dose Ara-C, TIT)
(2) IR and HR
Patients will be randomized to recieve either the experimental arm or the standard arm therapy. HR patients will receive allogeneic hematopoietic stem cell transpl
high-dose Ara-C, MIT, TIT)+gemtuzumab ozogamicin (GO)], Consolidation-2(HCEI+GO), and Consolidation-3(HCM+GO)
b) Standard arm: Consolidation-1(HCM), Consolidation-2(HCEI), and Consolidation-3(HCM)
D060828, D060830, D000079982, D018380
Sponsors
Koh Katsuyoshi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Diagnosis of AML (2) Age 0 to <16 years at diagnosis (3) ECOG performance status (PS) score or JPLSG Infant Leukemia Committee PS score of 0 to 3; those with PS score 4 is also eligible if that is derived from AML (4) Newly diagnosed AML without prior therapy for AML; history of steroid, ATRA due to suspicion of APL, or single intrathecal methotrexate due to suspicion of ALL are permitted (5) Sufficient organ function meeting both laboratory data listed below (should be evaluated =<7 days of trial entry); Serum T-Bil: <3x of the age-dependent normal range Serum creatinine: <3x of the age-dependent normal range (6) Prior consent to participating the JPLSG-CHM-14 study is mandatory (7) Written informed consent from the legal guardian.
Exclusion criteria
Exclusion criteria: (1) = grade 3 intracranial hemorrhage (CTCAE ver 5.0) (7) Presence of other malignant neoplasms (8) Other inappropriate status judged by physician (9) Patients considered as inappropriate to participate in the trial judged by the primary investigators and co-investigators
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 3-year disease-free survival (DFS) rate of the non-LR patients (IR and HR) | — |
Secondary
| Measure | Time frame |
|---|---|
| CR rate Overall survival (OS) Event-free survival (EFS) Cumulative incidence of relapse (CIR) Non-relapse mortality (NRM) Incidence of grade 3 or higher aderse events defined by CTCAE ver.5.0 Evaluation of the patients' Quality of Life (QOL) obtained from the patients' family questionnaire OS, EFS, CIR, and NRM according to the MRD levels at TP1 Rate of transplant-related complications and mortality at day 100 and at one year Incidence of invasive fungal infections according to the GO randomization Incidence of invasive fungal infections according to the use of prophylactic anti-fungal agents Incidence of bacterial infections according to the use of prophylactic antibiotics | — |
Contacts
Public ContactDaisuke Tomizawa
National Center for Child Health and Development
Outcome results
None listed