UMIN-CTR Clinical Trial

Basic information
Public title	Prospective evaluation of minimal residual disease in acute myeloid leukemia using TIM-3 as a leukemia marker
Acronym	MRD study for acute myeloid leukemia using TIM-3 as a leukemic stem cell specific surface marker
Scientific Title	Prospective evaluation of minimal residual disease in acute myeloid leukemia using TIM-3 as a leukemia marker
Scientific Title:Acronym	MRD study for acute myeloid leukemia using TIM-3 as a leukemic stem cell specific surface marker
Region	Japan

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

Objectives
Narrative objectives1	Evaluation of the correlation between the prognosis of acute myeloid leukemia and the TIM-3-expressing residual leukemic stem cells along with therapy progression
Basic objectives2	Others
Basic objectives -Others	Evaluation of usefulness of TIM-3 as a marker for residual AML cells
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The correlation between the prognosis of acute myeloid leukemia and the TIM-3-expressing residual leukemic stem cells
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	Not applicable
Gender	Male and Female
Key inclusion criteria	(1) Untreated acute myeloid leukemia(AML) patients (2) The patients who understand the content of this study and agreed with participating in the study by own free will (3) Age over 16 years
Key exclusion criteria	(1) Refractory or relapsed acute myeloid leukemia patients (2)Secondary AML patients (3)Acute promyelocytic leukemia patients (4) A patient whom the researchers decide as an inappropriate case
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Middle name Last name Yoshikane Kikushige
Organization	Kyushu University
Division name	Department of Medicine and Biosystemic Sciences
Zip code
Address	3-1-1, Maidashi Higashiku, Fukuoka, Japan
TEL	092-642-5947
Email	kikusige@intmed1.med.kyushu-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Yoshikane Kikushige
Organization	Kyushu University
Division name	Department of Medicine and Biosystemic Sciences
Zip code
Address	3-1-1, Maidashi Higashiku, Fukuoka, Japan
TEL	092-642-5947
Homepage URL
Email	kikusige@intmed1.med.kyushu-u.ac.jp

Sponsor
Institute	Department of Medicine and Biosystemic Sciences, Kyushu University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Kyowa Hakko Kirin Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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	2018 Year 01 Month 24 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	No longer recruiting
Date of protocol fixation	2016 Year 02 Month 04 Day
Date of IRB	2016 Year 02 Month 04 Day
Anticipated trial start date	2016 Year 06 Month 01 Day
Last follow-up date	2024 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Sequential evaluation of TIM-3 positive AML cells using multi-color FACS

Management information
Registered date	2018 Year 01 Month 24 Day
Last modified on	2019 Year 07 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000029682