UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000823 |
|---|---|
| Receipt number | R000000965 |
| Scientific Title | Phase III Randomized Study of Imatinib therapy in chornic phase chronic myeloid leukemia comparing standard dose-escalation with progressive dose-escalation (JALSG CML207study) |
| Date of disclosure of the study information | 2007/09/15 |
| Last modified on | 2011/09/09 10:01:08 |
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Basic information
Public title
Phase III Randomized Study of Imatinib therapy in chornic phase chronic myeloid leukemia comparing standard dose-escalation with progressive dose-escalation (JALSG CML207study)
Acronym
Phase III Randomized Study of Imatinib therapy in chornic phase chronic myeloid leukemia comparing standard dose-escalation with progressive-one (JALSG CML207study)
Scientific Title
Phase III Randomized Study of Imatinib therapy in chornic phase chronic myeloid leukemia comparing standard dose-escalation with progressive dose-escalation (JALSG CML207study)
Scientific Title:Acronym
Phase III Randomized Study of Imatinib therapy in chornic phase chronic myeloid leukemia comparing standard dose-escalation with progressive-one (JALSG CML207study)
Region
| Japan |
Condition
Condition
Previously untreated Chronic-phase chronic myelogenous leukemia
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Coparison of the rate of major molecular response at 12 months between standard dose-escalation of imatinib and progressive dose-escalation among previous untreated chronic phase chronic myelogenous leukemia patients
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
Molecular response at 12 months of imatinib therapy
Key secondary outcomes
1 Overall survival at three years
2 Cytogenetic response at 2 years
3 Adverse events grade 3 and more
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
imatinib
Interventions/Control_2
imatinib
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
| 15 | years-old | <= |
Age-upper limit
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Previously untreated chronic phase CML
2. Age: 15=< <70
3. PS 0-3 (ECOG)
4. No severe major organ dysfunction
5. Written informed consent
Key exclusion criteria
1. Other active neoplasma
2. Severe infection
3. Anticancer drug other than hydoroxurea in 2 weeks
4. Severe psychological disorders such as shizophrenia
5. Pregnant and/or lactating woman
6. Uncontorlled diabetis meritis
7. Acute myocardial infarction in 1 year or history of heart failure
8. Liver chirosis
9. Otherwise eligible
Target sample size
240
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Koichi Miyamura |
Organization
Japanese Red Cross Nagoya First Hospital
Division name
Department of Hematology
Zip code
Address
3-35 Michishita-cho, Nakamura-ku, Nagoya
TEL
052-481-511
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Koichi Miyamura |
Organization
Japanese Red Cross Nagoya First Hospital
Division name
Department of hematology
Zip code
Address
3-35 Michishita-cho, Nakamura-ku, Nagoya
TEL
052-481-511
Homepage URL
http://miwa.hama-med.ac.jp/jalsg/
miyamu@nagoya-1st.jrc.or.jp
Sponsor or person
Institute
Japan Adult Leukemia Study Group
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labor and Welfare
Organization
Division
Category of Funding Organization
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
| 2007 | Year | 09 | Month | 15 | 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
No longer recruiting
Date of protocol fixation
| 2007 | Year | 06 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2007 | Year | 09 | Month | 09 | Day |
Last modified on
| 2011 | Year | 09 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000965
