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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007351
Receipt No. R000008661
Scientific Title Estimation of outcome by FRET Analysis for Newly diagnosed CML-CP patients treated with Tasigna
Date of disclosure of the study information 2012/02/27
Last modified on 2017/02/27

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Basic information
Public title Estimation of outcome by FRET Analysis for Newly diagnosed CML-CP patients treated with Tasigna
Acronym EsoFANTA study
Scientific Title Estimation of outcome by FRET Analysis for Newly diagnosed CML-CP patients treated with Tasigna
Scientific Title:Acronym EsoFANTA study
Region
Japan

Condition
Condition Newly diagnosed Chronic Myelogenous Leukemia in chronic phase
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 To assess the efficacy and safety of Nilotinib in newly diagnosed Ph chromosome-positive (Ph+) CML patients.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes To assess the efficacy of twice daily administration of Nilotinib at a dose of 300 mg in newly diagnosed Ph chromosome-positive (Ph+) CML patients based on the rate of major molecular response at 12 months after starting treatment.
Key secondary outcomes 1) To assess the rate of complete cytogenetic response (CCyR), major molecular response and (MMR) and complete molecular response (CMR) every 12 months by 24 months.
2) To assess the level of bcr-abl mRNA in peripheral blood by QRT-PCR, Amp-CML and neutrophil FISH every 3 months. To validate the correlation of each methods.
3) To assess the level of bcr-abl mRNA in bone marrow by QRT-PCR every 12 months by 24 months.
4) To assess the progression-free survival (PFS), the event-free survival (EFS), and the overall survival (OS) at 5 years.
5) To assess the actual dose intensity at 12 months in the groups which have achieved a MMR and the groups which have not achieved a MMR.
6) To assess the safety of twice daily administration of Nilotinib 300 mg dosage.
7) To evaluate the utility of drug-sensitivity test by FRET analysis.

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 twice daily at a dose of 300 mg (600 mg/day) .
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
15 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Patient who has the Philadelphia chromosome or Major bcr-abl transcript at the first visit.
2) Patient who has not experienced a blast or accelerated phase of CML before treatment with Nilotinib.
3) Patient who has never received TKI tretment.
4) Patient with the ECOG performance status of 0, 1 or 2.
6) Patient who meets the following criteria for laboratory tests.
(1) T.Bill < 1.5 X ULN
(2) AST and ALT < 2.5 X ULN
(3) ALP < 2.5 X ULN
(4) Cre 1.5 < 1.5 X ULN
(5) AMY and Lipase < 1.5 X ULN
(6) K > LLN
(7) Mg > LLN
(8) IP > LLN
(9) Corrected Ca > LLN
(10) LVEF>45% or LLN by echocardiography
(11) QTc<450 msec by electrocardiography
6) Patient from whom an informed consent for the clinical study has been obtained.
Key exclusion criteria 1) Patient who exhibits the T315I BCR-ABL mutation.
2) Patient who is pregnant or breastfeeding.
3) Patient does not agree to use contraceptive methods to prevent pregnancy.
4) Patient who has any cardiac disturbances including the following conditions.
(1) Unmeasurable QT interval by ECG
(2) Complete left bundle branch block
(3) Use of a ventricular pacemaker
(4) Congenital long QT syndrome or family history of long QT syndrome
(5) History or complication of serious ventricular or atrial tachycardia
(6) Clinically serious resting bradycardia(<50 bpm)
(7) History of clinically diagnosed myocardial infarction
(8) History of unstable angina within 12 months before start of study
(9) Other clinically important heart diseases
5)Patient who has CNS involvement of leukemic cells
6)Patient who has severe or not-controlled illness other than CML
7)Patient who has a hereditary or acquired bleeding illness unrelated to CML
8)Patient who has a history of non-adherence to medications or patient from whom an informed consent can not be obtained.
9)
10)Patient who has any gastrointestinal disorders or diseases which may affect the absorption of the study drug.
11)Patients who has a history of acute or chronic pancreatitis within one year.
12)Patients who has hepatic disease, pancreatic disease, or severe renal disease unrelated to the primary disease.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takanori Teshima
Organization Hokkaido University Hospital
Division name Department of Hematology
Zip code
Address Kita 14 Nishi 5, Kita-ku, Sapporo
TEL +81-11-706-7214
Email teshima@med.hokudai.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takeshi Kondo
Organization Hokkaido University Hospital
Division name Department of Hematology
Zip code
Address Kita 14 Nishi 5, Kita-ku, Sapporo
TEL +81-11-706-7214
Homepage URL
Email t-kondoh@med.hokudai.ac.jp

Sponsor
Institute Hokkaido University Hospital, Department of Hematology
Institute
Department

Funding Source
Organization Hokkaido University
Organization
Division
Category of Funding Organization Self funding
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 北海道大学病院、旭川医科大学、愛育病院、釧路労災病院、北楡病院、旭川市立病院、北楡病院、札幌市立病院、KKR斗南病院、手稲渓仁会病院、開成病院、NTT東日本札幌病院、北海道がんセンター(以上、北海道)
Hokkaido University Hospital, Asahikawa Medical University, Kushiro Rosai Hospital, Aiiku Hospital, Sapporo Kosei Hospital, Asahikawa City Hospital,Hokuyu Hospital, Sapporo City General Hospital, KKR Tonan Hospital, Teine Keijinkai Hospital, Kaisei Hospital, NTT East Corp. Hospital, National Hospital Organization Hokkaido Cancer Center (Hokkaido, Japan)

Other administrative information
Date of disclosure of the study information
2012 Year 02 Month 27 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 Completed
Date of protocol fixation
2011 Year 09 Month 16 Day
Date of IRB
Anticipated trial start date
2011 Year 10 Month 01 Day
Last follow-up date
2019 Year 12 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2012 Year 02 Month 21 Day
Last modified on
2017 Year 02 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008661

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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