NIPH Clinical Trials Search

Treatment protocol for acute promyelocytic leukemia -FBMTG-APL2009-

Basic Information

Recruitment status	Complete: follow-up complete
Health condition(s) or Problem(s) studied	acute promyelocytic leukemia
Date of first enrollment	2009/03/01
Target sample size	50
Countries of recruitment	Japan
Study type	Interventional
Intervention(s)	APL patients who present white blood cell count > 3,000 on admission, will receive high-dose of cytarabine plus intrathecal injection in addition to conventional chemotherapy plus ATRA therapy at the consolidation chemotherapy. APL patients who present white blood cell count < 3,000 on admission, will receive conventional chemotherapy combined with ATRA therapy.

Outcome(s)

Primary Outcome	3 years disease-free survival
Secondary Outcome	5 years disease free survival, CR rate, treatment-related toxicities

Key inclusion & exclusion criteria

Age minimum	15years-old
Age maximum	65years-old
Gender	Male and Female
Include criteria
Exclude criteria	1. The case having double cancers 2. The case with an infectious disease having difficulty with control 3. The case with a severe mental disorder 4. The pregnancy or breast-feeding woman 5. The case that the medical attendant judged to be inappropriate