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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000007141
Receipt No. 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

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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
Email

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
Email i.matsu@med.kindai.ac.jp

Sponsor
Institute Cooperative study between the West Japan Hematology Study Group and the Clinical Research Support Center Kyushu
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008409

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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