A phase III randomized trial for B-cell precursor ALL

A multicenter phase III study in children, adolescent and young adult, and adults with newly diagnosed B-cell precursor acute lymphoblastic leukemia - JPLSG-ALL-B19

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs041210040

Enrollment

2000

Registered

2021-07-13

Start date

2021-07-13

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 B cell precursor Acute Lymphoblastic Leukemia

Interventions

The patients are divided into 4 groups based on risk classification and treated in each group as follows. Risk classification is performed based on age, white blood cell count at diagnosis, leukemic b

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Diagnosis of B cell precursor ALL or pre-B-ALL (2) Consent to FCM and fusion-gene screening (3) Age >=1 year and = 94% in room air (6) Written informed consent obtained from patient or guardians.

Exclusion criteria

Exclusion criteria: (1)BCR-ABL1 positive ALL (2)Down syndrome (3)Malignant hypertension (4)Pulmonary fibrosis (5)Interstitial pneumonia (6)Liver cirrhosis (7)Positive anti-HIV antibody or HBs antigen (8)Uncontrolled diabetes (9)Uncontrolled infection (10)Deep thrombosis requiring treatment. (11)Mental disorder that will likely make it impossible to complete treatment according to the protocol (12)Active double cancer (13)Pregnant or lactating woman, or high possibility of pregnancy (14)Past History of congenital or acquired immunodeficiency (15)Any inappropriate status judged by the physician

Design outcomes

Primary

Measure	Time frame
Five years event free survival in RCT-LR Five years event free survival in RCT-HR Five years event free survival in RCT-S Five years event free survival in RCT-L	—

Secondary

Measure	Time frame
(1) Five years event free survival/overall survival of the whole group (2) Five years event free survival/overall survival of each risk group (3) Five years event free survival/overall survival of age and cumulative incidence of relapse (CI-R)/cumulative incidence of non-relapse mortality (CI-NRM) (4) Five years overall survival in RCT-S and RCT-L, and cumulative incidence of relapse (CI-R)/ cumulative incidence of non-relapse mortality(CI-NRM) (5) Five years overall survival in RCT-LR and RCT-HR, and cumulative incidence of relapse (CI-R)/cumulative incidence of non-relapse mortality(CI-NRM) (6) Remission rate after induction chemotherapy and MRD negative rate (7) Incidence of adverse events (8) Incidence of deep mycosis by treatment phase (9) Incidence of deep mycosis with or without prophylactic antifungal drugs (10) Completion rate of study (11) Five years event free survival rate and 6-MP dose per NUDT15 gene polymorphism (12) Late complications (13) Search for prognostic factors involved in the outcome (14) Estimation of quality of life (QOL) by Questionnaire survey to patients and families (15) Replacement rate to Erw-ASP.Five years overall survival in ASP replacement group, non-replacement group, discontinuation group, and cumulative incidence of relapse (CI-R)	—

Measure

Time frame

(1) Five years event free survival/overall survival of the whole group (2) Five years event free survival/overall survival of each risk group (3) Five years event free survival/overall survival of age and cumulative incidence of relapse (CI-R)/cumulative incidence of non-relapse mortality (CI-NRM) (4) Five years overall survival in RCT-S and RCT-L, and cumulative incidence of relapse (CI-R)/ cumulative incidence of non-relapse mortality(CI-NRM) (5) Five years overall survival in RCT-LR and RCT-HR, and cumulative incidence of relapse (CI-R)/cumulative incidence of non-relapse mortality(CI-NRM) (6) Remission rate after induction chemotherapy and MRD negative rate (7) Incidence of adverse events (8) Incidence of deep mycosis by treatment phase (9) Incidence of deep mycosis with or without prophylactic antifungal drugs (10) Completion rate of study (11) Five years event free survival rate and 6-MP dose per NUDT15 gene polymorphism (12) Late complications (13) Search for prognostic factors involved in the outcome (14) Estimation of quality of life (QOL) by Questionnaire survey to patients and families (15) Replacement rate to Erw-ASP.Five years overall survival in ASP replacement group, non-replacement group, discontinuation group, and cumulative incidence of relapse (CI-R)

—

Contacts

Public ContactKoh Katsuyoshi

Saitama Children's Medical Center

ko.katsuyoshi@saitama-pho.jp+81-48-601-2200

Outcome results

None listed

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