UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024984 |
|---|---|
| Receipt number | 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 | 2022/11/29 11:47:58 |
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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 | Itaru |
| Middle name | |
| Last name | Matsumura |
Organization
Kindai University, Faculty of Medicine
Division name
Department of Hematology and Rheumatology
Zip code
589-8511
Address
377-2, Ohno-Higashi Osaka-Sayama, Osaka
TEL
072-366-0221
i.matsu@med.kindai.ac.jp
Public contact
Name of contact person
| 1st name | Itaru |
| Middle name | |
| Last name | Matsumura |
Organization
Kinki University, Faculty of Medicine
Division name
Department of Hematology and Rheumatology
Zip code
589-8511
Address
377-2, Ohno-Higashi Osaka-Sayama, Osaka
TEL
072-366-0221
Homepage URL
http://www.jalsg.jp
i.matsu@med.kindai.ac.jp
Sponsor or person
Institute
Japan Adult Leukemia Study Group
Institute
Department
Personal name
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
Gene Ethical Review Board of tha Kinki University, Faculty of Medicine
Address
377-2, Ohno-Higashi Osaka-Sayama, Osaka
Tel
072-366-0221
zizen@med.kindai.ac.jp
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
51
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
| 2016 | Year | 11 | Month | 10 | Day |
Date of IRB
| 2016 | Year | 11 | Month | 24 | Day |
Anticipated trial start date
| 2016 | Year | 11 | Month | 24 | Day |
Last follow-up date
| 2022 | Year | 09 | Month | 30 | Day |
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
| 2022 | Year | 11 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028186
