NIPH Clinical Trials Search

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) studiedrelapsed acute promyelocytic leukemia (APL)
Date of first enrollment2005/12/01
Target sample size20
Countries of recruitmentJapan
Study typeInterventional
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


Primary OutcomeDisease free survival at 1 year
Secondary Outcome1.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 minimum18years-old
Age maximum65years-old
GenderMale and Female
Include criteria
Exclude criteria1. 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


public contact
Name Nobuhiko EMI
Address Dengakugakubo 1-98, Kutsukake, Toyoake, Aichi, JAPAN Japan
Telephone 0562-93-9243
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