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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000007944
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Tokyo Women's Medical University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009325

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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