UMIN ID: C000000400
Registered date:17/04/2006
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 |
Related Information
| Primary Sponsor | Japan Adult Leukemia Study Group |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Ministry of Health, Labor and Welfare |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Mitsuhiro Matsuda, MD, PhD |
| Address | 377-2 Ohno-Higashi, Osaka-Sayama, Osaka Japan |
| Telephone | 072-366-0221 |
| mmatsuda@med.kindai.ac.jp | |
| Affiliation | JALSG MDS206G study office Department of Hematology, Kinki University School of Medicine |
| scientific contact | |
| Name | Mitsuhiro Matsuda, MD, PhD |
| Address | 377-2 Ohno-Higashi, Osaka-Sayama, Osaka Japan |
| Telephone | 072-366-0221 |
| Affiliation | Kinki University School of Medicine Department of Hematology |