ALL-B12

JRCT ID: jRCTs041180101

Registered date:14/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: B cell precursor Acute Lymphoblastic Leukemia
• Date of first enrollment: 27/11/2012
• Target sample size: 1560
• Study type: Interventional

Intervention(s)

Standard Risk(SR) experimental arm:
Criteria: NCI-SR (age<10y and WBC<50,000/mm^3 ) and prednisolone good responder (PGR) and day15 BM=M1/2 and TP1 BM=M1 without HR features.
Treatment: Reduced intensity BFM backbone treatment.
with VCR/DEX pulse during maintenance phase.

Standard Risk(SR) control arm:
Criteria: NCI-SR (age<10y and WBC<50,000/mm^3 ) and prednisolone good responder (PGR) and day15 BM=M1/2 and TP1 BM=M1 without HR features.
Treatment: Reduced intensity BFM backbone treatment.
without VCR/DEX pulse during maintenance phase.

Intermediate Risk (IR) experimental arm:
Criteria:
(1) NCI-SR (age<10y and WBC<50,000/mm^3 ) and prednisolone good responder (PGR) and day15 BM=M3 and TP1 BM=M1 without HR features.
(2) NCI-HR (age>10y or WBC>50,000/mm^3 ) and prednisolone good responder (PGR) and day15 BM=M1/2 and TP1 BM=M1 without HR features.
Treatment: Standard BFM backbone treatment with intensive L-asaparaginase during intensification phase.

Intermediate Risk (IR) control arm:
Criteria:
(1) NCI-SR (age<10y and WBC<50,000/mm^3 ) and prednisolone good responder (PGR) and day15 BM=M3 and TP1 BM=M1 without HR features.
(2) NCI-HR (age>10y or WBC>50,000/mm^3 ) and prednisolone good responder (PGR) and day15 BM=M1/2 and TP1 BM=M1 without HR features.
Treatment: Standard BFM backbone treatment with intensive L-asaparaginase during intensification phase.

High Risk (HR) experimental arm:
Criteria: at least one of following features
-NCI-HR (age>10y or WBC>50,000/mm^3) and prednisolone good responder (PGR) and day15 BM=M3
-CNS-3
-prednisolone poor responder (PPR)
-MLL-AF4
-E2A-HLF
-Hypodiploid (<44)
Treatment: BFM backbone tretment with L-asparaginase and intrathecal therapy intensification combined with VCR intensification.

High Risk (HR) control arm:
Criteria: at least one of following features
-NCI-HR (age>10y or WBC>50,000/mm^3) and prednisolone good responder (PGR) and day15 BM=M3
-CNS-3
-prednisolone poor responder (PPR)
-MLL-AF4
-E2A-HLF
-Hypodiploid (<44)
Treatment: BFM backbone tretment with L-asparaginase and intrathecal therapy intensification combined with BFM block therapy.

Outcome(s)

• Primary Outcome: Five years event free survival of each risk group

Secondary Outcome

1) Five years event free survival, overall survival, and CNS relapse rate of whole group
2) Five years overall survival and CNS relapse rate of each risk group
3) Complete remission rate after induction (IA) and after early intensification (IB) of each risk group and whole group
4) Incidence of adverse events
5) Success rate of MRD estimation at time point 1 and time point 2. Correlation between MRD level and event free survival, overall survival
6) Estimation of quality of life (QOL) by Questionnaire survey to patients and families
7) Exploratory estimation of correlation between biological abnormality and prognosis

Key inclusion & exclusion criteria

• Age minimum: >= 1age old
• Age maximum: <= 19age old
• Gender: Both

Include criteria

1) diagnosis of B cell precursor ALL
2) age between 1 and 19 years old
3) ECOG performance status (PS) score of 0-2 .However, PS scores up to 3 are permitted when the deterioration of PS is thought to be due to leukemia.
4) no history of previous chemotherapy or radiation therapy
5) sufficient hepatic and renal function satisfying the laboratory data listed below ;
(1)T-Bili: within 3x of age adjusted upper-limit of normal range.
(2)Creatinine: within 3x of age adjusted upper-limit of normal range.
6) written informed consent obtained from
patient or guardians.

Exclude criteria

1) mature B-ALL
2) Ph positive ALL
3) True Mixed Lineage Leukemia
4) CNS hemorrage more than grade 3 of CTCAE v4.0
5) uncontrolled infection, including active tuberculosis and positive of HIV antibody.
6) pregnancy or high possibility of pregnancy and giving suck wiman.
7) history of congenital or acquired immunodeficiency.
8) QTfc, corrected by Fridericia formula as
QTfc = QT/RR*1/3, is more than 0.45 seconds.
9) any inappropriate status judged by
physician.

Related Information

• Primary Sponsor: Koh Katsuyoshi
• Source(s) of Monetary Support: Japan Agency for Medical Research and Development,National Center for Child Health and Development
• Secondary ID(s): UMIN000009339