UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007944 |
|---|---|
| Receipt number | R000009325 |
| Scientific Title | Stop imatinib or dasatinib study in CP-CML patients mainitaining complete molecular response for two years |
| Date of disclosure of the study information | 2012/06/01 |
| Last modified on | 2013/01/30 11:08:09 |
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Basic information
Public title
Stop imatinib or dasatinib study in CP-CML patients mainitaining complete molecular response for two years
Acronym
TWMU-TKI-STOP-Study
Scientific Title
Stop imatinib or dasatinib study in CP-CML patients mainitaining complete molecular response for two years
Scientific Title:Acronym
TWMU-TKI-STOP-Study
Region
| Japan |
Condition
Condition
chronic phase chronic myeloid leukemia
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assese efficacy and safety after cessation of imatinib or dasatinib in CP-CMP patients who maintain complete molecular response for two years
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Rate of CMR at 12 months after cessation of imatinib or dasatinib.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
After confirmation of CMR by RQ-PCR, imatinib is continuously administrated for two years. Then, treatment is ceased.
Interventions/Control_2
After confirmation of CMR by RQ-PCR, dasatinib is continuously administrated for two years. Then, treatment is ceased.
Interventions/Control_3
After confirmation of CMR by RQ-PCR, imatinib is switched to dasatinib and continuously administrated for two years. Then, treatment is ceased.
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 Patients 20years or more
2 CP-CML patients
3 No extramedullary diseases except for hepatosplenomegaly
4 Ph chromosome or its variant forms demonstrated by cytogenetic or FISH analyses
5 Undetectable BCR-ABL transcripts by Amp-CML for three months.
Performance status 0-2 (ECOG)
Preserved function of vital organs including liver, kidney, lung.
Patients who agreed to participate this clinical trial, and signed to informed consent form.
Key exclusion criteria
1 Active primary double cancers
2 Pregnant or breast-feeding women
3 Patients who are not considered apropriate candicdates for this clinical trial by the investigators, because of past history of diseases, co-morbidities, or other reasons.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshiko Motoji |
Organization
Tokyo Women's Medical University
Division name
Dept. Hematology
Zip code
Address
8-1 Kawada-cho, Shinjuku-ku, Tokyo
TEL
03-3353-8111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masayuki Shiseki |
Organization
Tokyo Women's Medical University
Division name
Dept. Hematology
Zip code
Address
TEL
03-3353-8111
Homepage URL
Sponsor or person
Institute
Tokyo Women's Medical University
Institute
Department
Personal name
Funding Source
Organization
Tokyo Women's Medical University
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
Address
Tel
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 | 06 | 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
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
Open public recruiting
Date of protocol fixation
| 2012 | Year | 05 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2018 | Year | 09 | Month | 01 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 05 | Month | 14 | Day |
Last modified on
| 2013 | Year | 01 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009325
