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The phase IV study for comparing the response of high-dose cytarabine therapy among the KIT mutation status in adult core binding factor acute myeloid leukemia. -JALSG CBF-AML209-KIT Study (CBF-AML209-KIT)-

Basic Information

Recruitment status	Complete: follow-up complete
Health condition(s) or Problem(s) studied	Acute myeloid leukemia
Date of first enrollment	2010/02/01
Target sample size	200
Countries of recruitment	Japan
Study type	Interventional
Intervention(s)	Consolidation therapy consisted of 3 courses of high-dose cytarabine.

Outcome(s)

Primary Outcome	Disease-free survival at 2 years in CBF-AML patients with or without KIT mutation.
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum	16years-old
Age maximum	65years-old
Gender	Male and Female
Include criteria
Exclude criteria	(1) Secondary AML (2) The patients with the past history of hematopoietic disorder. (3) The patients who received the craniotomy. (4) The patients who received the total skull irradiation. (5) The patients who received the radiation therapy. (6) The patients who have been identified the cancer after the registration to the JALSG AML209-GS study. (7) The patients who have developed myocardial infarction or angina after the registration to the JALSG AML209-GS study. (8) The patients with cardiac dysfunction. (9) The patients with active gastric ulcer. (10) The patients with the uncontrollable ileus. (11) The patients with the diabetes mellitus. (12) The patients with active infection. (13) The patients in whom the HBV-reactivation have been observed. (14) Psycological patients.