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)-

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)- - The study for comparing the response of high-dose cytarabine therapy among the KIT mutation status in adult core binding factor acute myeloid leukemia.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000003434

Enrollment

200

Registered

2010-04-02

Start date

2010-02-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute myeloid leukemia

Interventions

Consolidation therapy consisted of 3 courses of high-dose cytarabine.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) JALSG AML209-GS study registered patient. (2) The patients with RUNX1-RUNX1T1 and CBFB-MYH11 transcripts. (3) The patients who achieved CR within 2 courses of the induction therapy (4) The patients who are not received the post-remission therapy. (5) The patients with Performance status grade (ECOG) 0,1 or 2. (6) The patients with the chemotherapy tolerable liver, kidney, lung and cardiac functions.

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Disease-free survival at 2 years in CBF-AML patients with or without KIT mutation.	—

Countries

Japan

Contacts

Public ContactHitoshi Kiyoi

Nagoya University Hospital Department of Hematology

kiyoi@med.nagoya-u.ac.jp052-744-2136

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026