Japanese Pediatric Leukemia/Lymphoma Study Group (JPLSG) ALL-B12: A Multi-Center Phase II/III Study in Children with Newly Diagnosed B-cell Precursor Acute Lymphoblastic Leukemia

Japanese Pediatric Leukemia/Lymphoma Study Group (JPLSG) ALL-B12: A Multi-Center Phase II/III Study in Children with Newly Diagnosed B-cell Precursor Acute Lymphoblastic Leukemia - A Multi-Center Phase II/III Study in Children with B-cell Precursor ALL: JPLSG ALL-B12

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000009339

Enrollment

1560

Registered

2012-11-16

Start date

2012-11-16

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

B cell precursor Acute Lymphoblastic Leukemia

Interventions

Standard Risk(SR) experimental arm: Criteria: NCI-SR (age&lt

10y and WBC&lt

50,000mm3 ) 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 pha

50,000mm3 ) 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

50,000mm3 ) and prednisolone good responder (PGR) and day15 BM=M3 and TP1 BM=M1 without HR features. (2) NCI-HR (age&gt

10y or WBC&gt

50,000mm3 ) 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

50,000mm3) and prednisolone good responder (PGR) and day15 BM=M3 -CNS-3 -prednisolone poor responder (PPR) -MLL-AF4 -E2A-HLF -Hypodiploid (&lt

44) Treatment: BFM backbone tretment with L-asparaginase and intrathecal therapy intensification combined with VCR

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) diagnosis of B cell precursor ALL 2) age between 1 and 19 years old 3) ECOG performance status (PS) score of 0-3 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.

Exclusion criteria

Exclusion criteria: 1) mature B-ALL 2) Ph positive ALL 3) True Mixed Lineage Leukemia 4) CNS hemorrage more than grade 3 of CACAE 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 Friderics formula as QTfc = QT/RR*1/3, is more than 0.45 seconds. 9) any inappropriate status judged by physician.

Design outcomes

Primary

Measure	Time frame
Five years event free survival of each risk group	—

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

Japan

Contacts

Public ContactKatsuyoshi Koh

Saitama Children's Medical Center Department of Hematology/Oncology

kkohtokyo@gmail.com0486012200

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026