NIPH Clinical Trials Search

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

Basic Information

Recruitment status	Complete: follow-up complete
Health condition(s) or Problem(s) studied	High risk myelodysplastic syndrome and MDS/secondary AML
Date of first enrollment	2006/04/05
Target sample size	41
Countries of recruitment	Japan
Study type	Interventional
Intervention(s)	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.

Outcome(s)

Primary Outcome	Complete remission rate
Secondary Outcome	Overall survival, event-free survival, relapse-free survival, toxicity

Key inclusion & exclusion criteria

Age minimum	15years-old
Age maximum	65years-old
Gender	Male and Female
Include criteria
Exclude 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