UMIN-CTR Clinical Trial

Basic information
Public title	Clinical research of safety and efficacy after a stop of dasatinib administration in patients with chronic myeloid leukemia -chronic phase (CML-CP) achieving a complete molecular response (CMR) on a treatment of tyrosine kinase inhibitors (TKIs).
Acronym	Stop dasatinib study (STDAST)
Scientific Title	Clinical research of safety and efficacy after a stop of dasatinib administration in patients with chronic myeloid leukemia -chronic phase (CML-CP) achieving a complete molecular response (CMR) on a treatment of tyrosine kinase inhibitors (TKIs).
Scientific Title:Acronym	Stop dasatinib study (STDAST)
Region	Japan

Condition
Condition	Chronic myeloid leukemia -chronic phase (CML-CP)
Classification by specialty	Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	The efficacy after a stop of dasatinib administration will be investigated in patients with CML-CP who have maintained CMR for 2 years on the treatment of TKIs.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Phase II

Assessment
Primary outcomes	The CMR maintenance rate at 1 year after a stop of dasatinib administration in patient who have maintained CMR for 2 years in treatment of TKIs.
Key secondary outcomes	* The CMR maintenance rate at 2 and 3 years ,and relapse free survival (RFS), event free survival (EFS) , progression free survival (PFS) and overall survival (OS) at 1, 2 and 3 years after a stop of dasatinib administration in patient who have maintained CMR for 2 years after a start of clinical study. *The 2 year CMR maintenance rate of patients at 24 months after the start of study. * The relationship between the time to CMR or MMR achievement and CMR maintenance rate at 1, 2 and 3 year after the stop of administration. * The search for predictive factor of a stop of dasatinib administration. * The relationship between the CMR maintenance rate and the following factors. - age, sex, Sokal score - treatment duration of TKIs - Total duration of BCR-ABL negative conversion to pre-registration. - LGL incidence - total treatment period and total dose of dasatinib * CMR achievement rate after re-administration in recurrent case after stop of dasatinib administration. * Safety

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	In accordance with the approved dosage, 2 x 50 mg tablets of dasatinib are taken once daily (100 mg/day) for 2 years.
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	CML-CP patients that corresponds to all the following criteria 1) CML-CP patients on treatment of imatinib, nilotinib or dasatinib. 2) Patients without blast phase or accelerated phase CML. 3) No extramedullary leukemia except hepatomegalia and splenoma. 4) Patients with Ph+ or wild type in myeloid cytogenetics. 5) Patients for CMR within 3 months before registration (Amp-CML: <5 copies/assay, PCR: <=0.0032%) 6) Age >=16 years 7) ECOG performance status of 0-2 8) Laboratory test as follows 1. Albumin: >= LLN 2. Total bilirubin: <= 3xULN 3. AST & ALT: <= 3xULN 4. Creatinine: <= 3xULN 5. Potassium: >= LLN 6. Magnesium: >= LLN 9) No pleural effusion in chest X-ray. 10) SpO2: >=94% 11) Patient in compliance with the prescribed visit schedule. 12) Written informed consent from the patient.
Key exclusion criteria	1) Patients who attend other clinical trial. 2) BCR-ABL point mutation (T315I, F317L, V299L) 3) QTc interval prolongation (>450msec) 4) Patient who has clear pleural effusion 5) Patients who have the following cardiovascular dysfunction 1. Impossible to measure QT interval in ECG 2. Complete left bundle branch block 3. Internal pacemaker 4. Congenital long QT syndrome or family history 5. Tachycardia 6. Bradycardia (<50bpm) 7. Myocardial infarction within 6 months 8. Angina pectoris within 3 months 9. Congestive heart failure within 3 months 10. Patient who have the complications of cardiovascular disorder 6) Active double cancer 7) Pregnant or breastfeeding woman 8) Patient who have complications with serious or poor control 9) Mental disorder 10) Cognitive dysfunction 11) Patient who judges the investigator to have difficulty in participation in study.
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Koichi Middle name Last name AKASHI
Organization	Graduate School of Medical Sciences, Kyushu University
Division name	Department of Medicine and Biosystemic Science
Zip code	812-8582
Address	3-1-1, Maidashi, Higashi-ku, Fukuoka 812-8582, Japan
TEL	092-642-5225
Email	akashi@med.kyushu-u.ac.jp

Public contact
Name of contact person	1st name Toshihiro Middle name Last name Miyamoto
Organization	Graduate School of Medical Sciences, Kyushu University
Division name	Department of Medicine and Biosystemic Science
Zip code	812-8582
Address	3-1-1, Maidashi, Higashi-ku, Fukuoka 812-8582, Japan
TEL	092-642-5225
Homepage URL
Email	toshmiya@intmed1.med.kyushu-u.ac.jp

Sponsor
Institute	CML stem cell study group
Institute
Department

Funding Source
Organization	Clinical Research Support Center Kyushu
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	NPO Clinical Research Network Fukuoka
Address	3-1-1 Maidashi, Higashi-ku, Fukuoka, Fukuoka 812-8582, Japan
Tel	092-643-7171
Email	mail@crnfukuoka.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

九州大学病院（福岡県）,中国中央病院（広島県）、浜の町病院（福岡県）、りんくう総合医療センター（大阪府）、生長会府中病院（大阪府）、鹿児島大学病院（鹿児島県）、金沢医科大学病院（石川県）、長岡中央綜合病院（新潟県）、千早病院（福岡県）、宮崎大学病院（宮崎県）、大阪市立大学病院（大阪府）、社会保険神戸中央病院（兵庫県）、岡山医療センター（岡山県）、島根大学病院（島根県）、香川大学病院（香川県）、原三信病院（福岡県）、徳島県立中央病院（徳島県）、京都大学病院（京都府）、山口県立総合医療センター （山口県）、大阪大学病院（大阪府）、高知大学病院（高知県）、久留米大学病院（福岡県）、神鋼病院（兵庫県）、宮崎県立宮崎病院（宮崎県）、近畿大学医学部奈良病院（奈良県）、九州がんセンター（福岡県）、獨協医科大学病院（栃木県）、愛媛県立中央病院（愛媛県）、滋賀医科大学病院（滋賀県）、和歌山医療センター（和歌山県）、鹿児島医療センター（鹿児島県）、市立豊中病院（大阪府）、長岡赤十字病院（新潟県）、近江八幡市立総合医療センター（滋賀県）、愛媛大学（愛媛県）、小倉記念病院（福岡県）、近畿大学（大阪府）、広島西医療センター（広島県）、兵庫県立西宮病院（兵庫県）、近畿大学医学部堺病院（大阪府）、那覇市立病院（沖縄県）、岡山市立市民病院（岡山県）、金沢大学（石川県）、九州医療センター（福岡県）、大津赤十字病院（滋賀県）、新潟県立中央病院（新潟県）、滋賀県立成人病センター（滋賀県）、松山赤十字病院（愛媛県）、福岡大学病院（福岡県）、岡山大学病院（岡山県）、埼玉県立がんセンター（埼玉県）、福岡東医療センター（福岡県）、川崎医科大学（岡山県）、北九州市立医療センター（福岡県）、九州厚生年金病院（福岡県）、大阪南医療センター（大阪府）、住友病院（大阪府）、聖マリア病院（福岡県）、大手前病院（大阪府）、上ヶ原病院（兵庫県）、帝京大学医学部附属病院（東京都）、奈良県立医科大学附属病院（奈良県）、東京医科大学病院（東京都）、高槻赤十字病院（大阪府）、獨協医科大学越谷病院（埼玉県）、新潟市民病院（新潟県）、山口大学病院（山口県）、福井大学病院（福井県）、市立堺病院（大阪府）、ハートライフ病院（沖縄県）、市立宇和島病院（愛媛県）、NTT西日本金沢病院（石川県）、宝塚市立病院（兵庫県）、松江赤十字病院（島根県）、古賀総合病院（宮崎県）、沖縄赤十字病院（沖縄県）、産業医科大学病院（福岡県）

Other administrative information
Date of disclosure of the study information	2012 Year 08 Month 01 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	141
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	2012 Year 07 Month 12 Day
Date of IRB	2012 Year 07 Month 26 Day
Anticipated trial start date	2012 Year 08 Month 01 Day
Last follow-up date	2019 Year 10 Month 24 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2012 Year 07 Month 31 Day
Last modified on	2020 Year 08 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000010082