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Post remission therapy with arsenic trioxide and gemtuzumab ozogamicin in acute promylocytic leukemia, a phase II study (JALSG APL212 Study)

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	Adult acute promylocytic leukemia
Date of first enrollment	2012/07/01
Target sample size	222
Countries of recruitment	Japan
Study type	Interventional
Intervention(s)	all-trans retinoic acid idarubicin cytarabine arsenic trioxide daunorubicin gemtuzumab ozogamicin tamibarotene (Am80)

Outcome(s)

Primary Outcome

3-year event free survival (EFS)

Secondary Outcome

1. Complete remission rate (CR) 2. 3- and 5-year disease free survival (DFS)of patients in CR 3. 3- and 5-year overall survival (OS) 4. 5-year event free survival (EFS) 5. CR, DFS and OS of each group 6. Adverse events. 7. Analyses of PML-RARA isoform, FLT3/ITD mutation, CD56 expression, additional chromosome abnormality and their effects on prognosis 8. Coagulation and fibrinolysis factors, and their effects on prognosis. 9. Determination of genetic abnormality and polymorphism of by genome and exome analyses for treatment related adverse events including APL differentiation syndrome. 10. Determination of genetic abnormality and polymorphism of by genome and exome analyses for the efficacy of treatment.

Key inclusion & exclusion criteria

Age minimum	15years-old
Age maximum	64years-old
Gender	Male and Female
Include criteria
Exclude criteria	1. History of myelodysplastic syndrome 2. Atypical acute leukemia 3. Uncontrollable infection 4. Severe co-morbidity 5. Positive anti-HIV antibody, HBs antigen or anti-HCV antibody 6. Other active neoplasm 7. Pregnant and/or lactating woman 8. Psychological disorders 9. Patients who have a difficulty to enter the study.