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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000002579
Receipt No. R000003140
Scientific Title Clinical study evaluating efficacy of Nilotinib in CML patients
Date of disclosure of the study information 2009/10/04
Last modified on 2012/02/14

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Basic information
Public title Clinical study evaluating efficacy of Nilotinib in CML patients
Acronym Clinical study evaluating efficacy of Nilotinib in CML patients
Scientific Title Clinical study evaluating efficacy of Nilotinib in CML patients
Scientific Title:Acronym Clinical study evaluating efficacy of Nilotinib in CML patients
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 assess the efficacy and safety of Nilotinib in Ph chromosome-positive (Ph+) CML patients with Imatinib resistance or intolerance.
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 400 mg in Ph chromosome-positive (Ph+) CML patients with Imatinib resistance or intolerance based on the rate of major molecular response at 12 months after starting treatment.
Key secondary outcomes

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 400 mg (800 mg/day) for 1 year.
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) Patients with Chronic Myeloid Leukemia (CML) in chronic phase, diagnosed with
Philadelphia chromosome positive (Ph+)
2) Patients diagnosed with failure or intolerant for prior Imatinib therapy.
3) Patients over or equal to 15 years of age
4) ECOG performance status score of 0-2
5) Patients with acceptable internal organs function meet the following requirements.
Serum creatinine concentration less than 3 x the upper limit of the normal range of the laboratory where the analysis is performed.
Total serum bilirubin level less than 3 x the upper limit of the normal range of the laboratory where the analysis is performed.
AST(GOT) and ALT(GPT) level less than 5 x the upper limit of the normal range of the laboratory where the analysis is performed.
Lipase level less than 2 x the upper limit of the normal range of the laboratory where the analysis is performed.
QTc interval under or equal to 480 msec.
6) NYHA criteria class of 1-2
7) Patients who can receive treatment at fixed intervals on outpatient basis
8) Informed consent signed up.

Key exclusion criteria 1) Patients suspected in accelerated phase(AP) or in blast crisis(BC).
2) Confirmed the expression of T315I mutation at genetic screening.
3) Previously treated with any other agents or therapy for CML, other than Hydroxyurea,
Interferon-alfa, and Imatinib.
4) History of a invasive double cancer within 5 years before.
5) Presence of serious or uncontrolled concomitant disease.
6) Pregnancy or possibility of pregnancy positive.
7) Women with lactation status or patients who have willing of pregnancy.
8) Patients suffering mental disorder or psychotic symptom.

Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuo Tsubaki
Organization Nara Hospital Kinki University School Of Medicine


Division name Department of Hematology
Zip code
Address 1248-1 Otsuda, Nara, 630-0293 JAPAN
TEL 0743-77-0880
Email

Public contact
Name of contact person
1st name
Middle name
Last name Kazuo Tsubaki
Organization Nara Hospital Kinki University School Of Medicine
Division name Department of Hematology
Zip code
Address
TEL 0743-77-0880
Homepage URL
Email

Sponsor
Institute Nara Hospital Kinki University School Of Medicine
Institute
Department

Funding Source
Organization Nara Hospital Kinki University School Of Medicine
Organization
Division
Category of Funding Organization Other
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
2009 Year 10 Month 04 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
2009 Year 05 Month 15 Day
Date of IRB
Anticipated trial start date
2009 Year 06 Month 01 Day
Last follow-up date
2012 Year 03 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
2009 Year 10 Month 03 Day
Last modified on
2012 Year 02 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003140

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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