Japanese Pediatric Leukemia/Lymphoma Study Group (JPLSG) AML-D11:A Phase II Study to evaluate the feasibility and utility of minimal residual disease (MRD) for childhood acute myeloid leukemia with Down syndrome

Japanese Pediatric Leukemia/Lymphoma Study Group (JPLSG) AML-D11:A Phase II Study to evaluate the feasibility and utility of minimal residual disease (MRD) for childhood acute myeloid leukemia with Down syndrome - AML-D11

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000007237

Enrollment

Registered

2012-03-01

Start date

2012-03-01

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

Acute myeloid Leukemia Myelodysplastic syndrome

Interventions

Single common courses of remission induction multi-agent combination chemotherapy for all the eligible patients For Standard Risk group(SR), 4 courses of intensification multi-agent combination chemo

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)AML(excluding APL) and MDS with Down syndrome 2)age more than 4 month and less than 18 years old 3)ECOG performance status score of 0-3 4)no history of previous chemotherapy (except administration of cytarabine for transient myeloproliferative disorder) or radiotherapy 5)sufficient hepatic, renal, and cardiac function satisfying the laboratory data listed below: T-Bil: within 3 times of the age-dependent normal range serum creatinine value: within 3 times of the age-dependent normal range ECG: no severe abnormalities (example; QTc >0.45) 6)written informed consent obtained from guardians

Exclusion criteria

Exclusion criteria: 1)CNS hemorrhage which is likely to intervent protocol therapy 2)uncontrolled DM 3)uncontrolled cardiac failure 4)pregnancy 5)unmanageable infectious disease 6)history of congenital or acquired immunodeficiency 7)CNS leukemia 8)any inappropriate status judged by physician

Design outcomes

Primary

Measure	Time frame
Positive rate of MRD after induction therapy and at the end of chemotherapy	—

Secondary

Measure	Time frame
Evaluable rate of MRD Positive rate of GATA1 mutation Event free survival rate Overall survival rate Incidence of adverse events during chemotherapy	—

Countries

Japan

Contacts

Public ContactTakashi Taga

Shiga University of Medical Science Pediatrics

jplsgdata@nnh.hosp.go.jp077-548-2228

Outcome results

None listed

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