UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008995 |
|---|---|
| Receipt number | R000010107 |
| Scientific Title | A multicenter phase IV clinical trial to examine the change of low-grade side effects after switch to Nilotinib from other tyrosine kinase inhibitors. |
| Date of disclosure of the study information | 2012/09/27 |
| Last modified on | 2014/05/19 09:42:21 |
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Basic information
Public title
A multicenter phase IV clinical trial to examine the change of low-grade side effects after switch to Nilotinib from other tyrosine kinase inhibitors.
Acronym
A multicenter phase IV clinical trial to examine the change of low-grade side effects after switch to Nilotinib from other tyrosine kinase inhibitors.
Scientific Title
A multicenter phase IV clinical trial to examine the change of low-grade side effects after switch to Nilotinib from other tyrosine kinase inhibitors.
Scientific Title:Acronym
A multicenter phase IV clinical trial to examine the change of low-grade side effects after switch to Nilotinib from other tyrosine kinase inhibitors.
Region
| Japan |
Condition
Condition
CML chronic phase
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Firstly, the objective is to elucidate the potential side effects by surveying the patients who are on TKI therapy for CML-CP. Secondly, we are aiming to examine the degree of amelioration of the side effects after we switch to Nilotinib from other TKIs.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
The change of the side effects that had been observed before, at 3 months after we switch to Nilotinib from Imatinib or Dasatinib.
Key secondary outcomes
All safety profiles.
The duration from switch to Nilotinib to amelioration of the side effects.
The anti-cancer effects after switch to Nilotinib.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
1) Ph positive CML patients
2) In CP phase at the entry point
3) Received TKI for more than 1 year in total
4) aged 20 or above
5) ECOG Performance Status 0~2
6) Without major organ (liver, kidney, lung) dysfunctions
7) Fulfills the following labo data.
1. T.Bil <= 3 X ULN
2. AST / ALT <= 5 X ULN
3. s-Cr <= 3 X ULN
4. neutrophil counts>=1,000/mm3
5. platelet counts>=50,000/mm3
6. ECG QTc < 480msec
8) Be able to visit the particiating hospital at the scheduled points.
9) With written informed consent
Key exclusion criteria
1) Patients who receive other therapy than TKI for CML
2) Patients participatinng in other clinical trials
3) Patients with bcr-ablT315I mutation
4) Patients who underwent stem cell transplantation
5) Patients with severe or uncontrolled coexisting illness
6) Patients with active malignancies
7) Patients with acute or chronic diseases in liver, pancreas, or severe kidney dysfunction, which is not atttributable to CML
8) Patients in pregnancy, lactation, or not be consent to control births
9) Patients who are assumed ineligible by the primary investigators or corresponding doctors.
Target sample size
55
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mineo Kurokawa |
Organization
The University of Tokyo Hospital
Division name
Dep. of Hematology & Oncology
Zip code
Address
Bunkyo-ku Hongo 7-3-1, Tokyo
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasuhito Nannya |
Organization
Tokyo CML Conference
Division name
Office for low grade side effect trial
Zip code
Address
TEL
03-3815-5411(35609)
Homepage URL
Sponsor or person
Institute
Tokyo CML Conference
Institute
Department
Personal name
Funding Source
Organization
The Univerity of Tokyo
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
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
| 2012 | Year | 09 | Month | 27 | 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
Terminated
Date of protocol fixation
| 2012 | Year | 05 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2014 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2014 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2015 | Year | 06 | Month | 30 | Day |
Other
Other related information
The observation point is the change of the side effects that had been observed before, at 3 months after we switch to Nilotinib from Imatinib or Dasatinib.
Management information
Registered date
| 2012 | Year | 09 | Month | 27 | Day |
Last modified on
| 2014 | Year | 05 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010107
