UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007141 |
|---|---|
| Receipt number | R000008409 |
| Scientific Title | Multicenter Phase II Clinical Study of the Safety and Efficacy of Discontinuing Nilotinib Treatment in Patients with Chronic Phase Chronic Myelogenous Leukemia Who Have Achieved Complete Molecular Response with Imatinib or Nilotinib |
| Date of disclosure of the study information | 2012/02/01 |
| Last modified on | 2013/08/19 10:31:38 |
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Basic information
Public title
Multicenter Phase II Clinical Study of the Safety and Efficacy of Discontinuing Nilotinib Treatment in Patients with Chronic Phase Chronic Myelogenous Leukemia Who Have Achieved Complete Molecular Response with Imatinib or Nilotinib
Acronym
Stop Nilotinib trial (NILSt trial)
Scientific Title
Multicenter Phase II Clinical Study of the Safety and Efficacy of Discontinuing Nilotinib Treatment in Patients with Chronic Phase Chronic Myelogenous Leukemia Who Have Achieved Complete Molecular Response with Imatinib or Nilotinib
Scientific Title:Acronym
Stop Nilotinib trial (NILSt trial)
Region
| Japan |
Condition
Condition
Chronic Myelogenenous Leukemia
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To investigate the safety and efficacy of discontinuing nilotinib treatment in patients with chronic myelogenous leukemia in the chronic phase (CML-CP) who have achieved a complete molecular response (CMR) with imatinib or nilotinib therapy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase II
Assessment
Primary outcomes
CMR rate at 1 year after discontinuation of nilotinib treatment in patients who have maintained CMR for 2 years after initiation of the study.
Key secondary outcomes
* CMR maintenance rate at 2 and 3 years after the discontinuation of nilotinib treatment and relapse-free survival (RFS), event-free survival (EFS), progression-free survival (PFS), and overall survival (OS) at 1, 2, and 3 years after discontinuation in patients who maintain CMR for 2 years after initiation of the study.
* Percentage of patients who have maintained CMR for 2 years at 24 months after initiation of the study.
* Correlation between the time to CMR or MMR and the CMR maintenance rate at 1, 2, and 3 years after discontinuation of treatment.
* Correlation between the CMR duration prior to the discontinuation of nilotinib treatment and the CMR rate at 1, 2, and 3 years after discontinuation.
* Investigation of predictors of the discontinuation of nilotinib treatment.
* To investigate patient demographic and pharmacokinetic factors that explain differences between patients with and without relapse after discontinuation of nilotinib.
* CMR rate after re-administration of nilotinib in patients with relapse following the discontinuation of nilotinib treatment.
* 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
Nilotinib will be administered at a dose of 300 mg (2 X 150 mg capsules) twice daily (600 mg/day) for 2 years.
However, if a patient was taking 800 mg/day of nilotinib prior to initiation of the study, the same dosage should be continued. If a patient can maintain CMR for 2 years after the initiation of treatment, nilotinib should be discontinued at that time and the patient should be carefully followed up for a further 3 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 or nilotinib.
2) Patients who have never had blast crisis or accelerated CML.
3) Patients with confirmed CMR based on the result of an assay conducted within 3 months prior to registration.
4) Age 16 years or older.
5) Patients with an ECOG performance status of 0-2.
6) Written informed consent from the subject.
Key exclusion criteria
1) Patients previously treated by tyrosine kinase inhibitors other than imatinib or nilotinib.
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
120
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
No longer 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
| 2013 | Year | 08 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008409
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