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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000024984
Receipt No. R000028186
Scientific Title Discontinuation study of nilotinib in patients with chronic myeloid leukemia who have maintained complete molecular remission for at least 2 years: the prospective, multicenter stop study in Japan adult leukemia study group
Date of disclosure of the study information 2016/11/24
Last modified on 2017/05/25

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Basic information
Public title Discontinuation study of nilotinib in patients with chronic myeloid leukemia who have maintained complete molecular remission for at least 2 years: the prospective, multicenter stop study in Japan adult leukemia study group
Acronym JALSG-N-STOP216
Scientific Title Discontinuation study of nilotinib in patients with chronic myeloid leukemia who have maintained complete molecular remission for at least 2 years: the prospective, multicenter stop study in Japan adult leukemia study group
Scientific Title:Acronym JALSG-N-STOP216
Region
Japan

Condition
Condition chronic myeloid leukemia
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 We try to evaluate treatment-free remission (TFR) rate in CML patients, who have been treated with nilotinib continuously from diagnosis and maintained complete molecular remission for more than 2 years.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes TFR rate at 12 months after nolotinib discontinuation
Key secondary outcomes 1. TFR rate at 24 months after nolotinib discontinuation
2. CMR rate at 12 months and 24 months after nilotinib discontinuation
3. Overall survival, progression-free survival, treatment-free survival, event-free survival
4. Relationship between TFR and CMR duration time, treatment duration time, early molecular response, Sokal risk stratification, and trough concentration
5. Efficacy of the retreatment with nilotinib for CML patients, who lost TFR
6. Analysis of clinical features of nilotinib withdrawal syndrome

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 Discontinuation of nilotinib and retreatment with nilotinib for CML patients who lost TFR
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. BCR-ABL-positive CML patients in chronic phase (CP)
2. CML patients in CP with ECOG Performance Status 0-2
3. CML patients in CP, who have been treated with nilotinib with a daily dose equal or more than 300mg for more than three years since diagnosis
4. CML patients in CP, who have maintained complete molecular response (CMR) for more than two years
5. CML patients in CP without severe (more than grade 3) adverse events by nilotinib
6. CML patients in CP, who agree to discontinuation of nilotinib
7. CML patients in CP, who can visit the hospital on scheduled days
8. CML patients in CP with written consent for the trial
Key exclusion criteria 1. CML patients in CP, who had an experience of treatment with TKI other than nilotinib or interferon-a for more than 4 weeks
2. CML patients in CP, who have been treated with nilotinib with a daily dose less than 300mg excepting transient dose reduction due to the adverse events
3. CML patients in CP, who had an experience of allogeneic hematopoietic stem cell transplantation
4. CML patients in CP with an episode of disease progression to accelerated or blastic phase
5. CML patients in CP with an episode of loss of CMR despite the continuous treatment with nilotinib
6. CML patients in CP with poor adherence to nilotinib
7.CML patients in CP, who don't accept retreatment with nilotinib after losing TFR
8. CML patients in CP with other inappropriate conditions for the trial
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Itaru Matsumura
Organization Kindai 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
Email i.matsu@med.kindai.ac.jp

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

Sponsor
Institute Japan Adult Leukemia Study Group
Institute
Department

Funding Source
Organization Japan Agency for Medical and Development
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

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
2016 Year 11 Month 24 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
2016 Year 11 Month 10 Day
Date of IRB
Anticipated trial start date
2016 Year 11 Month 11 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
2016 Year 11 Month 24 Day
Last modified on
2017 Year 05 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028186

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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