UMIN-CTR Clinical Trial

Public title

Multicenter Phase II Clinical Study on the Safety and Efficacy of Nilotinib in Patients with Chronic Myelogenous Leukemia-Chronic Phase and Major Molecular Response

Acronym

Switch to Tasigna Trial (STAT1)

Scientific Title

Multicenter Phase II Clinical Study on the Safety and Efficacy of Nilotinib in Patients with Chronic Myelogenous Leukemia-Chronic Phase and Major Molecular Response

Scientific Title:Acronym

Switch to Tasigna Trial (STAT1)

Region

Japan

Condition

Chronic Myelogenous Leukemia

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

YES

Narrative objectives1

To evaluate the safety and efficacy of nilotinib in patients with chronic myelogenous leukemia in the chronic phase (CML-CP) who have achieved a major molecular response (MMR) with imatinib.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

CMR rate at 24 months after the initiation of nilotinib treatment.

Key secondary outcomes

1) The rate of patients who have sustained CMR for more than 1 year at 24 months after the initiation of nilotinib treatment.
2) CMR rate at 12 months after the initiation of nilotinib treatment.
3) Overall survival (OS), progression-free survival (PFS) and event-free survival (EFS) at 12 and 24 months after the initiation of nilotinib treatment.
4) Relationship between the time needed to reach CCyR and MMR, the CMR rate at 24 months after the initiation of nilotinib, and the rate of patients sustaining CMR for more than 1 year.

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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.

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

Age-lower limit

16

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1) Patients with CML-CP under treatment with imatinib.
2) Patients who have never had blast crisis or accelerated CML.
3) Patients in whom MMR was demonstrated by an examination conducted within 1 year prior to registration and who have not reached CMR.
4) Age 16 years or older.
5) Patients with an ECOG performance status of 0-2.
6) 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
7) Patients who can attend the clinical study site in accordance with the pre-defined schedule.
8) Written informed consent from the subject (from the legal representative if the subject is under 20 years old).

Key exclusion criteria

1) Patients previously treated by tyrosine kinase inhibitors other than imatinib.
2) Patients who are participating in any other clinical trial.
3) Patients with the T315I point mutation of BCR-ABL.
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

120

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

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

Institute

Cooperative study among the East Japan CML Study Group, Shimousa Hematology Study Group, Leukemia Study Group in Mie, Niigata CML Study Group and the NPO Tohoku Hematology Expert Meeting

Institute

Department

Personal name

Organization

Novartis Pharma K.K.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2011

Year

07

Month

01

Day

URL releasing protocol

Publication of results

Published

URL related to results and publications

https://link.springer.com/article/10.1007%2Fs12185-018-2459-6

Number of participants that the trial has enrolled

Results

Primary Endpoint
CMR rate at 24 M was estimated at 44.6% (90%CI 34.7-54.8%).
Secondary Endpoints
CMR rate at 12 M was estimated at 27.0%(90%CI 18.7-36.3%).
Sustained CMR rate at 24 M was estimated at 20.3%(95%CI 11.1-29.4%).

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

Recruitment status

Completed

Date of protocol fixation

2011

Year

01

Month

31

Day

Date of IRB

Anticipated trial start date

2011

Year

07

Month

01

Day

Last follow-up date

2014

Year

12

Month

20

Day

Date of closure to data entry

2015

Year

01

Month

31

Day

Date trial data considered complete

2015

Year

08

Month

01

Day

Date analysis concluded

2015

Year

09

Month

25

Day

Other related information

Registered date

2011

Year

07

Month

01

Day

Last modified on

2019

Year

02

Month

26

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006982