Randomized controlled Phase 3 trial of all-trans retinoic acid(ATRA) versus new synthetic retinoid Tamibarotene(Am80) for maintenance therapy in patients with adult acute promyelocytic leukemia: Japan Adult Leukemia Study Group (JALSG) APL204 Study

UMIN ID: C000000154

Registered date:13/09/2005

Basic Information

• Health condition(s) or Problem(s) studied: acute promyelocytic leukemia
• Date of first enrollment: 2004/05/01
• Target sample size: 300
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

All-trans retinoic acid(ATRA) in maintenace therapy. Patients number requires 120.
Tamibarotene(Am80) in maintenance therapy. Patients number requires 120

Outcome(s)

• Primary Outcome: Primary endpoint is relapse free survival at the time of hematological or molecular relapse in maintenance therapy period.
• Secondary Outcome: Secondary endpoints include complete remission rate, event free survival(EFS), overall survival(OS) and frequency of adverse effects.

Key inclusion & exclusion criteria

• Age minimum: 15years-old
• Age maximum: 70years-old
• Gender: Male and Female
• Exclude criteria: Exclusion criteria are as follows, 1) Patients with uncontrolled infection including active tuberculosis. 2) Patients with severe complications: malignant hypertension, congestive heart failure, acute myocardial infarction occurred within 3 months, liver cirrhosis, poorly controlled diabetes mellitus, pulmonary fibrosis, interstitial pneumonitis, etc) 3) HIV or HBs or HCV are positive. 4) Patients with other malignancy that are untreated or uncontrollable. 5) During or possibility of pregnancy, and lactation for infants. 6) Patients with severe mental disorders. 7) Patients with past history of renal insufficiency. 8) Any conditions that may be inappropriate for registration judged by doctors concerning for patients.

Related Information

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