UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002579 |
|---|---|
| Receipt number | 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 14:11:53 |
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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
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
Sponsor or person
Institute
Nara Hospital Kinki University School Of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003140
