UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000007140
Receipt number R000008408
Scientific Title Multicenter Phase II Study of the Safety and Efficacy of Nilotinib in Patients with Chronic Phase Chronic Myelogenous Leukemia Showing a Major Molecular Response to Imatinib
Date of disclosure of the study information 2012/02/01
Last modified on 2012/04/17 14:45:55

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Basic information

Public title

Multicenter Phase II Study of the Safety and Efficacy of Nilotinib in Patients with Chronic Phase Chronic Myelogenous Leukemia Showing a Major Molecular Response to Imatinib

Acronym

Switch to Nilotinib trial (NILSw trial)

Scientific Title

Multicenter Phase II Study of the Safety and Efficacy of Nilotinib in Patients with Chronic Phase Chronic Myelogenous Leukemia Showing a Major Molecular Response to Imatinib

Scientific Title:Acronym

Switch to Nilotinib trial (NILSw trial)

Region

Japan


Condition

Condition

Chronic Myelogenous Leukemia

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

YES


Objectives

Narrative objectives1

The safety and efficacy of switching to nilotinib will be investigated in patients with chronic myelogenous leukemia in the chronic phase (CML-CP) who have achieved a major molecular response (MMR) with imatinib treatment.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Phase II


Assessment

Primary outcomes

The cumulative CMR rate by 24 months after the initiation of nilotinib treatment

Key secondary outcomes

* Percentage of patients maintaining CMR for more than 1 year by 24 month after the initiation of nilotinib treatment.
* Cumulative CMR rate by 12 months after the initiation of nilotinib treatment.
* Overall survival (OS), progression-free survival (PFS) and event-free survival (EFS) at 12 and 24 months after the initiation of nilotinib treatment.
* Correlation between the time to achieve CCyR or MMR and the cumulative CMR rate by 24 months after the initiation of nilotinib treatment or the percentage of patients maintaining CMR for more than 1 year.
* Correlation between the trough blood concentration of imatinib/nilotinib and the CMR rate or the percentage of patients maintaining CMR for more than 1 year.
* Factors that predict achieving CMR.
* Demographic factors that distinguish patients who achieved CMR from those who did not.
* Safety of nilotinib.


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

In accordance with the approved dosage and administration of nilotinib for patients with CML-CP resistant to imatinib, 2 X 200 mg capsules of nilotinib (400 mg) are taken twice daily (800 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



Eligibility

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 who have received imatinib for 18 months or longer.
4) Patients taking a regular dose of imatinib between 300 and 400 mg/day during the previous 6 months.
5) Patients in whom MMR was demonstrated by an examination conducted within 3 months prior to registration and who have not reached CMR.
6) Age 16 years or older.
7) Patients with an ECOG performance status of 0-2.
8) Written informed consent from the subject.

Key exclusion criteria

1) Patients previously treated by tyrosine kinase inhibitors other than imatinib.
2) Patients confirmed to have the T315I point mutation of BCR-ABL.
3) Patients with a history of hematopoietic stem cell transplantation.
4) Patients with cardiovascular dysfunction.
5) Pregnant women or those with suspected pregnancy. Nursing women and those who plan to become pregnant during the study period.

Target sample size

130


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Koichi AKASHI

Organization

Graduate School of Medical Sciences, Kyushu University

Division name

Department of Medicine and Biosystemic Science

Zip code


Address

3-1-1, Maidashi, Higashi-ku, Fukuoka 812-8582, Japan

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name Itaru MATSUMURA

Organization

Kinki University School of Medicine

Division name

Division of Hematology, Department of Internal Medicine

Zip code


Address

377-2, Ohno-Higashi, Osaka-Sayama 589-8511, Japan

TEL


Homepage URL


Email

i.matsu@med.kindai.ac.jp


Sponsor or person

Institute

Cooperative study between the West Japan Hematology Study Group and the Clinical Research Support Center Kyushu

Institute

Department

Personal name



Funding Source

Organization

Novartis Pharma K.K.

Organization

Division

Category of Funding Organization

Profit organization

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



Other administrative information

Date of disclosure of the study information

2012 Year 02 Month 01 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

Open public recruiting

Date of protocol fixation

2012 Year 02 Month 09 Day

Date of IRB


Anticipated trial start date

2012 Year 02 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2012 Year 01 Month 26 Day

Last modified on

2012 Year 04 Month 17 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008408


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name