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

UMIN ID: C000000206

Registered date:14/09/2005

Basic Information

• Recruitment status: Complete: follow-up continuing
• Health condition(s) or Problem(s) studied: acute promyelocytic leukemia (APL)
• Date of first enrollment: 1997/05/01
• Target sample size: 234
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

6 courses of maintenance/intencification therapy consisting of enocitabine, daunorubicin, mercaptopurine, mitoxantrone, etoposide, vindesine, and aclarubicin
no maintenance/intensification therapy

Outcome(s)

• Primary Outcome: relapse-free survival at 5 years
• Secondary Outcome: overall survival at 5 years, complete remission rate, event-free survival at 5 years, efficacy of detection of PML-RARalpha

Key inclusion & exclusion criteria

• Age minimum: 15years-old
• Age maximum: 70years-old
• Gender: Male and Female
• 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. 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

• Primary Sponsor: Japan Adult Leukemia Study Group
• Source(s) of Monetary Support: Ministry of Health, Labor and Welfare