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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000003939
Receipt No. R000004737
Scientific Title Safety of quitting imatinib in Japanese chronic myelogenous leukemia patients
Date of disclosure of the study information 2010/08/01
Last modified on 2010/09/08

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Basic information
Public title Safety of quitting imatinib in Japanese chronic myelogenous leukemia patients
Acronym JASQIM
Scientific Title Safety of quitting imatinib in Japanese chronic myelogenous leukemia patients
Scientific Title:Acronym JASQIM
Region
Japan

Condition
Condition chronic myelogenous leukemia
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Examine the safety of stopping imatinib in chronic myelogenous leukemia (CML) patients who achieve complete molecular response (CMR). Evaluate the safety and efficacy of combination of imatinib and interferon alpha in CML patients who achieve complete cytogenetic response but do not achieve CMR.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes ratio of maintaining CMR 24 months after stopping imatinib
Key secondary outcomes 1. ratio of maintaining CMR without relapse 24 months after stopping imatinib
2. cumulative ratio of relapse within 24 months after stopping imatinib
3. ratio of CMR achievement within 12 months after stopping IFN-alpha
4. number of adverse events

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 stop imatinib if CMR is achieved
add IFN-alpha if CMR is not achieved
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 Preregistration
1. Patients with CML in 1st chronic phase who achieve CCR, more than 18 months after starting imatinib
2. >20 yrs old
3. Patients who are informed with documents
Registration
1. Patients who achieve CMR by Q-PCR and nested PCR, and remain in CMR after 6 months by Q-PCR and nested PCR
Key exclusion criteria 1. Patients in whom other treatments including transplantation are more eligible than this protocol
2. Patients who was previously administrated with IFN-alpha
3. Patients who have a history of allergic reaction to vaccines and other biologicals
4. Patients who were previously administered with Shyosaikoto
5. Patients who have autoimmune hepatitis
6. Patients who are pregnant or who expect to be pregnant during the study period
7. Patients in depression
8. Patients who have cytogenetic abnormalities if Ph chromosome is negative at the registration
9. Patients whose physician in charge judges inappropriate
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shigeru Chiba
Organization University of Tsukuba
Division name Tsukuba University Hospital
Zip code
Address 2-1-1- Amakubo, Tsukuba, Ibaraki
TEL 029-853-3103
Email

Public contact
Name of contact person
1st name
Middle name
Last name Mamiko Sakata-Yanagimoto
Organization University of Tsukuba
Division name Tsukuba University Hospital
Zip code
Address 2-1-1- Amakubo, Tsukuba, Ibaraki
TEL 029-853-3127
Homepage URL
Email sakatama-tky@umin.net

Sponsor
Institute Department of Clinical and Experimental Hematology, University of Tsukuba
Institute
Department

Funding Source
Organization Department of Clinical and Experimental Hematology, University of Tsukuba
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

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
2010 Year 08 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
2010 Year 06 Month 07 Day
Date of IRB
Anticipated trial start date
2010 Year 08 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2010 Year 07 Month 22 Day
Last modified on
2010 Year 09 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004737

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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