UMIN ID: C000000302
Registered date:30/12/2005
Phase II Clinical Trial to test efficacy and safety of relapsed APL (JALSG APL205R study)
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | relapsed acute promyelocytic leukemia (APL) |
| Date of first enrollment | 2005/12/01 |
| Target sample size | 20 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | This protocol is composed of the following four steps of therapy. 1.Induction therapy :Arsenic trioxide regime 2.Consolidation therapy: two couses of ATO regime 3.PBSCH: High dose araC regime 4.Autologous PBSCT |
Outcome(s)
| Primary Outcome | Disease free survival at 1 year |
|---|---|
| Secondary Outcome | 1.Frequency of abnormal reactions 2.Complete remission rate 3.The amount of CD34 positive cell in PBSCH 4.Frequency of PML/RAR positivity 5.Engraftment of autologous stem cell transplantation 6.Overall Survival 7.Risk analysis |
Key inclusion & exclusion criteria
| Age minimum | 18years-old |
|---|---|
| Age maximum | 65years-old |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | 1. Uncontrolled active infection 2. Past history of myocardial infarction or cardiac failure 3. Past history of renal failure 4. Uncontrolled diabetes mellitus 5. Liver cirrhosis 6. Abnormal reaction to ATO and AraC 7. Another severe and/or life threatening disease 8. Pregnant and/or lactating woman 9. Relapse after stem cell transplantation 10.Impossible to process this protocol |
Related Information
| Primary Sponsor | Japan adult leukemia study group ( JALSG) |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Ministry of Helath,Labor and Walfare |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Nobuhiko EMI |
| Address | Dengakugakubo 1-98, Kutsukake, Toyoake, Aichi, JAPAN Japan |
| Telephone | 0562-93-9243 |
| nemi@fujita-hu.ac.jp | |
| Affiliation | JALSG Office for JALSG APL205R |
| scientific contact | |
| Name | Nobuhiko EMI |
| Address | Fujita Health University School of Medicine Japan |
| Telephone | 0562-93-9243 |
| Affiliation | Japan adult leukemia study group ( JALSG APL205R) Dep. of Hematology |