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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005904
Receipt No. R000006983
Scientific Title Multicenter Clinical Study on the Safety and Efficacy of Nilotinib Discontinuation in Patients with Chronic Myelogenous Leukemia-Chronic Phase and Complete Molecular Response
Date of disclosure of the study information 2011/07/01
Last modified on 2018/11/07

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Basic information
Public title Multicenter Clinical Study on the Safety and Efficacy of Nilotinib Discontinuation in Patients with Chronic Myelogenous Leukemia-Chronic Phase and Complete Molecular Response
Acronym Stop Tasigna Trial (STAT2)
Scientific Title Multicenter Clinical Study on the Safety and Efficacy of Nilotinib Discontinuation in Patients with Chronic Myelogenous Leukemia-Chronic Phase and Complete Molecular Response
Scientific Title:Acronym Stop Tasigna Trial (STAT2)
Region
Japan

Condition
Condition Chronic Myelogenous Leukemia
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 To evaluate the safety and efficacy of nilotinib discontinuation in patients with chronic myelogenous leukemia in the chronic phase (CML-CP) who achieved a complete molecular response (CMR).
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes CMR rate at 1 year after discontinuation of nilotinib treatment in patients who have sustained CMR for 2 years after initiation of the study.
Key secondary outcomes 1) CMR rate at 2 and 3 years after discontinuation of nilotinib treatment in patients who have sustained CMR for 2 years after initiation of the study. Recurrence-free survival (RFS), event-free survival (EFS), progression-free survival (PFS), and overall survival (OS) at 1, 2, and 3 years after the discontinuation of nilotinib.
2) Rate of patients who have sustained CMR for 2 years at 24 months after initiation of the study.
3) Correlation between the time to CMR/MMR and the CMR rate at 1, 2, and 3 years after the discontinuation of treatment.
4) Correlation between the CMR duration prior to the discontinuation of nilotinib treatment and the CMR rate at 1, 2, and 3 years after discontinuation.
5) Exploration of predictors of CMR sustenance during nilotinib treatment.

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 2 capsules (150 mg) of nilotinib will be taken twice daily (600 mg/day) for 2 years. Patients who sustain CMR for 2 years following 2 years of treatment then discontinue the study medication and are carefully followed up for another 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 who have never had blast crisis or accelerated CML.
2) Patients with confirmed CMR based on the result of an assay conducted within 1 year prior to registration
3) Age 16 years or older.
4) Patients with an ECOG performance status of 0-2.
5) Patients who have the following clinical laboratory values:
i) Serum bilirubin (T.Bil) <=1.5 X the upper limit of normal for the clinical study site (ULN)
ii) AST and ALT <=2.5 X ULN
iii) Alkaline phosphatase (ALP) <=2.5 X ULN
iv) Serum creatinine (s-Cr) <=3.0 X ULN
v) Serum lipase <=1.5 X ULN
vi) Potassium (K) >=the lower limit of normal at the clinical study site (LLN)
vii) Magnesium (Mg) >= LLN
viii) Phosphate (IP) >= LLN
ix) Total calcium (Ca) (after adjustment by serum albumin) >= LLN
x) QTc <450 msec on ECG
6) Patients who can attend the clinical study site in accordance with the pre-defined schedule.
7) Written informed consent from the subject (from the legal representative if the subject is under 20 years old).
Key exclusion criteria 1) Patients who are participating in any other clinical trial.
2) Patients with the T315I point mutation of BCR-ABL.
3) Patients with a history of hematopoietic stem cell transplantation.
4) Patients with one of the following indicators of cardiovascular dysfunction.
i) The QT interval cannot be measured on the ECG
ii) Complete left bundle branch block
iii) Ventricular pacemaker
iv) Congenital QT interval prolongation syndrome or a family history of QT interval prolongation syndrome
v) History of or current severe ventricular or atrial tachycardia
vi) Clinically significant bradycardia at rest (<50 bpm)
vii) History of clinically diagnosed myocardial infarction
viii) History of unstable angina within 12 months prior to initiation of the study
ix) Other clinically significant cardiovascular complications
5) Patients with another primary malignant tumor.
6) Gastrointestinal dysfunction or diseases that could greatly influence absorption of the study medication.
7) Patients with a history of acute or chronic pancreatitis within 1 year prior to participation to the study.
8) Pregnant women or those with suspected pregnancy. Nursing women and those who plan to become pregnant during the study period.
9) Patients with multiple invasive cancers within 5 years prior to initiation of the study.
10) Patients with other serious or uncontrollable complications.
11) Patients with a psychiatric illness or symptoms that make it difficult to participate in the study.
12) Patients with cognitive dysfunction.
13) Other patients whom the investigator considers to be unsuitable for participation in the study.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Naoto Takahashi
Organization Akita University School of Medicine
Division name Department of Hematology, Nephrology and Rheumatology
Zip code
Address 1-1-1 Hondo, Akita, 010-8543, Japan
TEL 018-884-6115
Email naotot@doc.med.akita-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Naoto TAKAHASHI
Organization Akita University School of Medicine
Division name Department of Hematology, Nephrology and Rheumatology
Zip code
Address 1-1-1 Hondo, Akita, 010-8543, Japan
TEL 018-884-6115
Homepage URL
Email naotot@doc.med.akita-u.ac.jp

Sponsor
Institute Akita university and the NPO Tohoku Hematology Expert Meeting
Institute
Department

Funding Source
Organization Novartis Pharma K.K.
Organization
Division
Category of Funding Organization Profit organization
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
2011 Year 07 Month 01 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://www.haematologica.org/content/haematol/103/11/1835.full.pdf
Number of participants that the trial has enrolled
Results
We recruited 96 Japanese patients, of whom 78 sustained a deep molecular response during the consolidation phase and were therefore eligible to discontinue nilotinib in the treatment-free remission phase; of these, 53 patients (67.9%; 95% confidence interval: 56.4-78.1%) remained free from molecular recurrence in the first 12 months. The estimated 3-year treatment-free survival was 62.8%. Nilotinib was readministered to all patients (n=29) who experienced a molecular recurrence during the treatment-free remission phase. After restarting treatment, rapid deep molecular response returned in 25 patients (86.2%), with 50% of patients achiev- ing a deep molecular response within 3.5 months. Tyrosine kinase inhibitor withdrawal syndrome was reported in 11/78 patients during the early treatment-free remission phase. The treatment-free survival curve was significantly better in patients with undetectable molecular residual disease than in patients without (3-year treatment-free sur- vival, 75.6 versus 48.6%, respectively; P=0.0126 by the log-rank test). There were no significant differences in treatment-free survival between subgroups based on tyrosine kinase inhibitor treatment before the nilotinib consolidation phase, tyrosine kinase inhibitor- withdrawal syndrome, or absolute number of natural killer cells. The results of this study indicate that it is safe and feasible to stop tyrosine kinase inhibitor therapy in patients with chronic myeloid leukemia who have achieved a sustained deep molecular response with 2 years of treatment with nilotinib. 
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 Completed
Date of protocol fixation
2011 Year 05 Month 31 Day
Date of IRB
Anticipated trial start date
2011 Year 07 Month 01 Day
Last follow-up date
2018 Year 03 Month 01 Day
Date of closure to data entry
2018 Year 03 Month 15 Day
Date trial data considered complete
2018 Year 03 Month 15 Day
Date analysis concluded
2018 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2011 Year 07 Month 01 Day
Last modified on
2018 Year 11 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006983

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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