UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007413 |
|---|---|
| Receipt number | R000008734 |
| 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. |
| Date of disclosure of the study information | 2012/03/01 |
| Last modified on | 2020/09/07 11:16:01 |
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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
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
toshmiya@intmed1.med.kyushu-u.ac.jp
Sponsor or person
Institute
CML stem cell study group
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008734
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