Japanese Pediatric Leukemia/Lymphoma Study Group (JPLSG) CML-08: A Multi-Center Observational Study for Children with Chronic Phase of Chronic Myeloid Leukemia

Japanese Pediatric Leukemia/Lymphoma Study Group (JPLSG) CML-08: A Multi-Center Observational Study for Children with Chronic Phase of Chronic Myeloid Leukemia - A Multi-Center Observational Study for Children with Chronic Phase of CML: JPLSG CML-08

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000002581

Enrollment

Registered

2009-10-05

Start date

2009-10-01

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

Chronic Phase of Chronic Myeloid Leukemia (CML) in children

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Newly diagnosed BCR-ABL-positive chronic phase of CML 2) Age <18 years at initial diagnosis 3) Diagnosis after October 1st, 2009 4) Imatinib as first-line treatment 5) Written informed consent

Exclusion criteria

Exclusion criteria: CML without BCR-ABL rearrangement detectable by PCR

Design outcomes

Primary

Measure	Time frame
5-year progression-free survival (5y-PFS)	—

Secondary

Measure	Time frame
5-year event-free survival (5y-EFS) 5-year overall survival (5y-OS) Cumulative rates of CHR, CCyR, and MMR Correlation of the prognosis with early BCR-ABL/ABL mRNA ratio Correlation of the efficacy with bone marrow markers, imatinib trough level, BCR-ABL kinase domain mutaions Incidence rates of adverse effects	—

Countries

Japan

Contacts

Public ContactAkiko Saito

Japanese Pediatric Leukemia/Lymphoma study Group Data Center

nsgdata@nnh.hosp.go.jp052-951-1111

Outcome results