NIPH Clinical Trials Search

UMIN ID: C000000206

Registered date:14/09/2005

Multicenter study of a randomized controlled trial with or without maintenance/intensification therapy in patients with previously untreated acute promyelocytic leukemia (JALSG APL97 study)

Basic Information

Recruitment status Complete: follow-up continuing
Health condition(s) or Problem(s) studiedacute promyelocytic leukemia (APL)
Date of first enrollment1997/05/01
Target sample size234
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)6 courses of maintenance/intencification therapy consisting of enocitabine, daunorubicin, mercaptopurine, mitoxantrone, etoposide, vindesine, and aclarubicin no maintenance/intensification therapy


Primary Outcomerelapse-free survival at 5 years
Secondary Outcomeoverall survival at 5 years, complete remission rate, event-free survival at 5 years, efficacy of detection of PML-RARalpha

Key inclusion & exclusion criteria

Age minimum15years-old
Age maximum70years-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. Leukemic involvement in the CNS 7. Another severe and/or life threatening disease 8. Pregnant and/or lactating woman 9. Positive for HIV antibody test

Related Information


public contact
Name Norio Asou
Address 1-1-1 Honjo, Kumamoto, Kumamoto 860-8556, Japan Japan
Telephone 096-373-5156
Affiliation Kumamoto University School of Medicine Department of Hematology
scientific contact
Name Ryuzo Ohno
Address 1-1 Kakodono, Chigusa, Nagoya 464-8681, Japan Japan
Telephone 052-762-6111
Affiliation Aichi Cancer Center Honor Director