Treatment protocol for acute promyelocytic leukemia -FBMTG-APL2009-

UMIN ID: UMIN000001742

Registered date:01/03/2009

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
• 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

Related Information

• Primary Sponsor: Fukuoka Blood & Marrow Transplant Group
• Source(s) of Monetary Support: Fukuoka Blood & Marrow Transplant Group