UMIN-CTR Clinical Trial

Basic information
Public title	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)-
Acronym	The study for comparing the response of high-dose cytarabine therapy among the KIT mutation status in adult core binding factor acute myeloid leukemia.
Scientific Title	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)-
Scientific Title:Acronym	The study for comparing the response of high-dose cytarabine therapy among the KIT mutation status in adult core binding factor acute myeloid leukemia.
Region	Japan

Condition
Condition	Acute myeloid leukemia
Classification by specialty	Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to clarify the adequate application of the high-dose cytarabine post-remission therapy according to the KIT mutation status to adult core binding factor-acute myeloid leukemia with t(8;21)(q22;q22), inv(16)(p13.1q22)/t(16;16)(p13.1;q22).
Basic objectives2	Pharmacodynamics
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase IV

Assessment
Primary outcomes	Disease-free survival at 2 years in CBF-AML patients with or without KIT mutation.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Consolidation therapy consisted of 3 courses of high-dose cytarabine.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	16 years-old <=
Age-upper limit	65 years-old >
Gender	Male and Female
Key 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.
Key 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.
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Hitoshi Middle name Last name Kiyoi
Organization	Nagoya University Hospital
Division name	Department of IHematology
Zip code	466-8560
Address	65 Tsurumai-cho, Showa-ku, Nagoya, Japan
TEL	052-744-2136
Email	kiyoi@med.nagoya-u.ac.jp

Public contact
Name of contact person	1st name Hitoshi Middle name Last name Kiyoi
Organization	Nagoya University Hospital
Division name	Department of Hematology
Zip code	466-8560
Address	65 Tsurumai-cho, Showa-ku, Nagoya, Japan
TEL	052-744-2136
Homepage URL
Email	kiyoi@med.nagoya-u.ac.jp

Sponsor
Institute	Japan adult leukemia study group
Institute
Department

Funding Source
Organization	NPO JALSG supporting organization
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Nagoya University Ethical committee
Address	65 Tsurumai-cho, Showa-ku, Nagoya, Japan
Tel	052-744-2804
Email	ethics@med.nagoya-u.ac.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2010 Year 04 Month 02 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Main results already published
Date of protocol fixation	2010 Year 01 Month 12 Day
Date of IRB	2010 Year 02 Month 01 Day
Anticipated trial start date	2010 Year 02 Month 01 Day
Last follow-up date	2019 Year 03 Month 31 Day
Date of closure to data entry	2019 Year 03 Month 31 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2010 Year 04 Month 02 Day
Last modified on	2020 Year 04 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000004158