UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007140 |
|---|---|
| Receipt number | R000008408 |
| Scientific Title | Multicenter Phase II Study of the Safety and Efficacy of Nilotinib in Patients with Chronic Phase Chronic Myelogenous Leukemia Showing a Major Molecular Response to Imatinib |
| Date of disclosure of the study information | 2012/02/01 |
| Last modified on | 2012/04/17 14:45:55 |
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Basic information
Public title
Multicenter Phase II Study of the Safety and Efficacy of Nilotinib in Patients with Chronic Phase Chronic Myelogenous Leukemia Showing a Major Molecular Response to Imatinib
Acronym
Switch to Nilotinib trial (NILSw trial)
Scientific Title
Multicenter Phase II Study of the Safety and Efficacy of Nilotinib in Patients with Chronic Phase Chronic Myelogenous Leukemia Showing a Major Molecular Response to Imatinib
Scientific Title:Acronym
Switch to Nilotinib trial (NILSw trial)
Region
| Japan |
Condition
Condition
Chronic Myelogenous Leukemia
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
The safety and efficacy of switching to nilotinib will be investigated in patients with chronic myelogenous leukemia in the chronic phase (CML-CP) who have achieved a major molecular response (MMR) with imatinib treatment.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase II
Assessment
Primary outcomes
The cumulative CMR rate by 24 months after the initiation of nilotinib treatment
Key secondary outcomes
* Percentage of patients maintaining CMR for more than 1 year by 24 month after the initiation of nilotinib treatment.
* Cumulative CMR rate by 12 months after the initiation of nilotinib treatment.
* Overall survival (OS), progression-free survival (PFS) and event-free survival (EFS) at 12 and 24 months after the initiation of nilotinib treatment.
* Correlation between the time to achieve CCyR or MMR and the cumulative CMR rate by 24 months after the initiation of nilotinib treatment or the percentage of patients maintaining CMR for more than 1 year.
* Correlation between the trough blood concentration of imatinib/nilotinib and the CMR rate or the percentage of patients maintaining CMR for more than 1 year.
* Factors that predict achieving CMR.
* Demographic factors that distinguish patients who achieved CMR from those who did not.
* Safety of nilotinib.
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
In accordance with the approved dosage and administration of nilotinib for patients with CML-CP resistant to imatinib, 2 X 200 mg capsules of nilotinib (400 mg) are taken twice daily (800 mg/day) for 2 years.
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients with CML-CP under treatment with imatinib.
2) Patients who have never had blast crisis or accelerated CML.
3) Patients who have received imatinib for 18 months or longer.
4) Patients taking a regular dose of imatinib between 300 and 400 mg/day during the previous 6 months.
5) Patients in whom MMR was demonstrated by an examination conducted within 3 months prior to registration and who have not reached CMR.
6) Age 16 years or older.
7) Patients with an ECOG performance status of 0-2.
8) Written informed consent from the subject.
Key exclusion criteria
1) Patients previously treated by tyrosine kinase inhibitors other than imatinib.
2) Patients confirmed to have the T315I point mutation of BCR-ABL.
3) Patients with a history of hematopoietic stem cell transplantation.
4) Patients with cardiovascular dysfunction.
5) Pregnant women or those with suspected pregnancy. Nursing women and those who plan to become pregnant during the study period.
Target sample size
130
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Koichi AKASHI |
Organization
Graduate School of Medical Sciences, Kyushu University
Division name
Department of Medicine and Biosystemic Science
Zip code
Address
3-1-1, Maidashi, Higashi-ku, Fukuoka 812-8582, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Itaru MATSUMURA |
Organization
Kinki University School of Medicine
Division name
Division of Hematology, Department of Internal Medicine
Zip code
Address
377-2, Ohno-Higashi, Osaka-Sayama 589-8511, Japan
TEL
Homepage URL
i.matsu@med.kindai.ac.jp
Sponsor or person
Institute
Cooperative study between the West Japan Hematology Study Group and the Clinical Research Support Center Kyushu
Institute
Department
Personal name
Funding Source
Organization
Novartis Pharma K.K.
Organization
Division
Category of Funding Organization
Profit 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
| 2012 | Year | 02 | 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
| 2012 | Year | 02 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 02 | 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
| 2012 | Year | 01 | Month | 26 | Day |
Last modified on
| 2012 | Year | 04 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008408
