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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)

Phase 4
Conditions
Acute myeloid leukemia
Registration Number
JPRN-UMIN000003434
Lead Sponsor
Japan adult leukemia study group
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up complete
Sex
All
Target Recruitment
200
Inclusion Criteria

Not provided

Exclusion 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.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Disease-free survival at 2 years in CBF-AML patients with or without KIT mutation.
Secondary Outcome Measures
NameTimeMethod
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