NIPH Clinical Trials Search

UMIN ID: UMIN000001742

Registered date:01/03/2009

Treatment protocol for acute promyelocytic leukemia -FBMTG-APL2009-

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedacute promyelocytic leukemia
Date of first enrollment2009/03/01
Target sample size50
Countries of recruitmentJapan
Study typeInterventional
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.


Primary Outcome3 years disease-free survival
Secondary Outcome5 years disease free survival, CR rate, treatment-related toxicities

Key inclusion & exclusion criteria

Age minimum15years-old
Age maximum65years-old
GenderMale and Female
Include criteria
Exclude criteria1. 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

Related Information


public contact
Name Toshihiro Miyamoto
Address 3-1-1 Maidashi, Higashi-ku, Fukuoka 812-8582, Japan Japan
Telephone 092-642-5230
Affiliation Kyushu University Hospital Hematology/ Oncology
scientific contact
Name Tomohiko Kamimura
Address 1-8 Taihaku-cho, Hakata-ku, Fukuoka 812-0033, Japan Japan
Affiliation Harasanshin General Hospital Department of Hematology