UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003939 |
|---|---|
| Receipt number | 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 19:04:18 |
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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
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
sakatama-tky@umin.net
Sponsor or person
Institute
Department of Clinical and Experimental Hematology, University of Tsukuba
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004737
