Phase 2 study of G-CSF priming chemotherapy for high risk myelodysplastic syndrome (MDS) and MDS/secondary AML

Phase 2 study of G-CSF priming chemotherapy for high risk myelodysplastic syndrome (MDS) and MDS/secondary AML - Phase 2 study of G-CSF priming chemotherapy for high risk MDS and MDS/secondary AML

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-C000000400

Enrollment

Registered

2006-04-17

Start date

2006-04-05

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

High risk myelodysplastic syndrome and MDS/secondary AML

Interventions

Remission induction therapy: G-CSF (lenograstim), sic, day0-7. Cytarabine (Ara-C) 100mg/sqm, cont-div, day1-7. Idarubicin (IDR) 12mg/sqm, 30 min-div, day1-3.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1)Previously untreated RAEB-II or MDS/secondary AML (2)Age between 15 and 65 years old (3) Performance status between 0 and 2 (4) Adequate function of the liver (serum bilirubin level<2.0mg/dl), the kidney (serum creatinine level<2.0 mg/dl) and heart (no abnormalities seen on electrocardiograms and echocardiographs) (5)Written informed consent to participate the study

Exclusion criteria

Exclusion criteria: (1) Uncontrolled active infection (2) Other serious and/or life-threatening diseases (3) Another active primary malignancy (4) Severe mental retardation (5) Pregnant or lactating woman (6) Past illness of renal failure (7) Positive for HIV antibody and/or HBs antigen tests

Design outcomes

Primary

Measure	Time frame
Complete remission rate	—

Secondary

Measure	Time frame
Overall survival, event-free survival, relapse-free survival, toxicity	—

Countries

Japan

Contacts

Public ContactMitsuhiro Matsuda, MD, PhD

JALSG MDS206G study office Department of Hematology, Kinki University School of Medicine

mmatsuda@med.kindai.ac.jp072-366-0221

Outcome results

None listed

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