UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007221 |
|---|---|
| Receipt number | R000008503 |
| Scientific Title | Multicenter Clinical Study Evaluating the Safety and Efficacy of Dasatinib Treatment and its Discontinuation in Patients with Chronic Phase Chronic Myelogenous Leukemia who had Reached Complete Molecular Response during Imatinib Therapy |
| Date of disclosure of the study information | 2012/02/03 |
| Last modified on | 2020/12/02 14:59:14 |
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Basic information
Public title
Multicenter Clinical Study Evaluating the Safety and Efficacy of Dasatinib Treatment and its Discontinuation in Patients with Chronic Phase Chronic Myelogenous Leukemia who had Reached Complete Molecular Response during Imatinib Therapy
Acronym
Multicenter Clinical Study on the Safety and Efficacy of Dasatinib Discontinuation
Scientific Title
Multicenter Clinical Study Evaluating the Safety and Efficacy of Dasatinib Treatment and its Discontinuation in Patients with Chronic Phase Chronic Myelogenous Leukemia who had Reached Complete Molecular Response during Imatinib Therapy
Scientific Title:Acronym
Multicenter Clinical Study on the Safety and Efficacy of Dasatinib Discontinuation
Region
| Japan |
Condition
Condition
Chronic Phase Chronic Myelogenous Leukemia
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This study is designed to evaluate the efficacy and safety of dasatinib treatment and its discontinuation in patients with chronic myelogenous leukemia in the chronic phase (CML-CP) who achieved a complete molecular response (CMR) during imatinib therapy.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
CMR rate at 12 months after discontinuation of dasatinib treatment.
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
Dasatinib will be administered at 100 mg once daily for 24 months and then discontinue dasatinib therapy
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
Patients with chronic phase chronic myeloid leukemia who has been reached complete molecular response with imatinib treatment
Key exclusion criteria
1. Concurrent malignancy other than CML
2.Women who are pregnant or breastfeeding
3. A serious uncontrolled medical disorder that would impair the ability of the subjects to receive protocol therapy
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Eriko |
| Middle name | |
| Last name | Sato |
Organization
Juntendo University School of Medicine
Division name
Department of Hematology
Zip code
113-8431
Address
3-1-3 Hongo, Bunkyo-ku, Tokyo 113-8431, Japan
TEL
03-3813-3111
ersato@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Eriko |
| Middle name | |
| Last name | Sato |
Organization
Juntendo University School of Medicine
Division name
Department of Hematology
Zip code
113-8431
Address
3-1-3 Hongo, Bunkyo-ku, Tokyo 113-8431, Japan
TEL
03-3813-3111
Homepage URL
ersato@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Juntendo University School of Medicine
Address
3-1-3 Hongo, Bunkyo-ku, Tokyo 113-8431, Japan
Tel
03-5802-1584
chiken@juntendo.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
| 2012 | Year | 02 | Month | 03 | 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
Completed
Date of protocol fixation
| 2012 | Year | 01 | Month | 28 | Day |
Date of IRB
| 2012 | Year | 01 | Month | 27 | Day |
Anticipated trial start date
| 2012 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2030 | Year | 09 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 02 | Month | 03 | Day |
Last modified on
| 2020 | Year | 12 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008503
