UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007909 |
|---|---|
| Receipt number | R000009156 |
| Scientific Title | A prospective randomized study to compare the cumulative achievement of complete molecular response for adult de novo chronic myeloid leukemia in chronic phase between nilotinib and dasatinib (CML212 Study) |
| Date of disclosure of the study information | 2012/05/08 |
| Last modified on | 2016/10/19 20:09:30 |
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Basic information
Public title
A prospective randomized study to compare the cumulative achievement of complete molecular response for adult de novo chronic myeloid leukemia in chronic phase between nilotinib and dasatinib (CML212 Study)
Acronym
A prospective randomized study to compare the cumulative achievement of complete molecular response for adult de novo chronic myeloid leukemia in chronic phase between nilotinib and dasatinib (CML212 Study)
Scientific Title
A prospective randomized study to compare the cumulative achievement of complete molecular response for adult de novo chronic myeloid leukemia in chronic phase between nilotinib and dasatinib (CML212 Study)
Scientific Title:Acronym
A prospective randomized study to compare the cumulative achievement of complete molecular response for adult de novo chronic myeloid leukemia in chronic phase between nilotinib and dasatinib (CML212 Study)
Region
| Japan |
Condition
Condition
A prospective randomized study to compare the cumulative achievement of complete molecular response for adult de novo chronic myeloid leukemia in chronic phase between nilotinib and dasatinib (CML212 Study)
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
Comparison of Nilotinib and Dasatinib in term of the efficacy of achieving complete molecular response for de novo chronic myeloid leukemia in chronic phase
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase III
Assessment
Primary outcomes
Cumulative achievement of CMR by 18 months
Key secondary outcomes
Efficacy (Cytogenetic Response, Molecular Response)
PFS
Safety
Continuity
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
Nilotinib
Interventions/Control_2
Dasatinib
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Newly diagnosed chronic myeloid leukemia in chronic phase
2. PS 0-2 (ECOG)
3. Adequate hepatic, renal, pulmonary, pancreatic, and cardiac function
4. Written informed consent
Key exclusion criteria
1. History of the treatment with the tyrosine kinase inhibitor except for imatinib within two weeks
2. Registered case in the other clinical trial
3. Detected T315I mutation in the BCR-ABL gene
4. History of allogenic hematopoietic stem cell transplantation
5. Impaired cardiac function
6. Other active neoplasms
7. Active infection requiring the treatment
8. Pregnant and/or lactating woman
9. Severe psychiatric disorders
10. Severe or uncontrolled comorbidities (diabetes, etc.)
Target sample size
450
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Itaru Matsumura |
Organization
Kinki University, Faculty of Medicine
Division name
Department of Hematology and Rheumatology
Zip code
Address
377-2, Ohno-Higashi Osaka-Sayama, Osaka
TEL
072-366-0221
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Itaru Matsumura |
Organization
Kinki University, Faculty of Medicine
Division name
Department of Hematology and Rheumatology
Zip code
Address
377-2, Ohno-Higashi Osaka-Sayama, Osaka
TEL
072-366-0221
Homepage URL
http://www.jalsg.jp
i.matsu@med.kindai.ac.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
北海道 （39都道府県になります）
青森県
宮城県
秋田県
山形県
福島県
栃木県
茨城県
群馬県
埼玉県
千葉県
東京都
神奈川県
新潟県
富山県
石川県
福井県
長野県
岐阜県
静岡県
愛知県
三重県
滋賀県
京都府
大阪府
兵庫県
奈良県
島根県
岡山県
広島県
山口県
香川県
愛媛県
高知県
福岡県
長崎県
熊本県
大分県
鹿児島県
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 05 | Month | 08 | 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
| 2012 | Year | 04 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
| 2018 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2018 | Year | 09 | Month | 01 | Day |
Date analysis concluded
| 2018 | Year | 12 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 05 | Month | 08 | Day |
Last modified on
| 2016 | Year | 10 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009156
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
