UMIN-CTR Clinical Trial

Basic information
Public title	Phase II Study of Safety and Efficacy. Dasatinib in Patients with Chronic Phase Chronic Myelogenous Leukemia achieving a Major Molecular Response on Imatinib.
Acronym	Dasatinib CMR-trial
Scientific Title	Phase II Study of Safety and Efficacy. Dasatinib in Patients with Chronic Phase Chronic Myelogenous Leukemia achieving a Major Molecular Response on Imatinib.
Scientific Title:Acronym	Dasatinib CMR-trial
Region	Japan

Condition
Condition	Chronic phase chronic myelogenous leukemia
Classification by specialty	Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	The safety and efficacy of switching to dasatinib will be investigated in patients with chronic myelogenous leukemia in the chronic phase (CML-CP) who have achieved a major molecular response (MMR) on imatinib.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Phase II

Assessment
Primary outcomes	The cumulative CMR rate by 18 months after dasatinib treatment
Key secondary outcomes	*Cumulative CMR rate by 12 months and 24 months after the initiation of dasatinib treatment *Dose intensity in 12 months, a large granular lymphocyte: LGL incidence * Relevance of progression free survival: PFS, safety, Sokal score, and OS, PFS and EFS.

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 and administration of dasatinib for patients with CML-CP resistant to imatinib, 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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1)chronic-phase chronic myelogenous leukemia 2)Age 20 years or older 3) Patients for major molecular response (MMR) with no CMR on imatinib. 4) ECOG performance status of 0-2. 5) Adequate organ function (hepatic, renal and lung) 6)Written informed consent from the subject
Key exclusion criteria	1)Active double cancer 2)Pregnant or breastfeeding woman 3)Patient who has clear pleural effusion 4)Patient who have the anamnesis or complications of a cardiovascular disorder with serious or poor control. -myocardial infarction within 6 months -angina pectoris within 3 months -congestive heart failure within 3 months -congenital long QT syndrome
Target sample size	20

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	Kyushu University Hospital
Address	3-1-1 Maidashi, Higashi-ku, Fukuoka, Fukuoka 812-8582, Japan
Tel	092-631-2920
Email	h.aratani@cres-kyushu.or.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）、浜の町病院（福岡県）、九州医療センター（福岡県）、原三信病院（福岡県）、福岡東医療センター（福岡県）、久留米大学病院（福岡県）、聖マリア病院（福岡県）、北九州市立医療センター（福岡県）、産業医科大学病院（福岡県）、九州厚生年金病院（福岡県）、千早病院（福岡県）、小倉医療センター（福岡県）、飯塚病院（福岡県）、松山赤十字病院（愛媛県）、高知大学病院（高知県）、近畿大学病院（大阪府）、大阪市立病院（大阪府）、独協医科大学病院（栃木県）、愛媛大学病院（愛媛県）、香川大学病院（香川県）、徳島大学病院（徳島県）、徳島県立中央病院（徳島県）、近畿大学医学部奈良病院（奈良県）、りんくう総合医療センター（大阪府）、日本赤十字社　和歌山医療センター（和歌山県）、独立行政法人　国立病院機構　大阪南医療センター（大阪府）、虎の門病院（東京都）、市立堺病院（大阪府）

Other administrative information
Date of disclosure of the study information	2012 Year 03 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	20
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	Completed
Date of protocol fixation	2012 Year 02 Month 20 Day
Date of IRB	2012 Year 02 Month 29 Day
Anticipated trial start date	2012 Year 03 Month 01 Day
Last follow-up date	2015 Year 02 Month 04 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 03 Month 01 Day
Last modified on	2020 Year 09 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000008734