UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000007351
Receipt number 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 12:01:04

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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 or person

Institute

Hokkaido University Hospital, Department of Hematology

Institute

Department

Personal name



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

Value
https://center6.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