UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001927 |
|---|---|
| Receipt number | R000002325 |
| Scientific Title | A phase 2 multicenter clinical study evaluating the safety and efficacy of Nilotinib in patients with Imatinib- resistant/intolerant CML in chronic phase |
| Date of disclosure of the study information | 2009/05/01 |
| Last modified on | 2009/05/01 14:39:16 |
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Basic information
Public title
A phase 2 multicenter clinical study evaluating the safety and efficacy of Nilotinib in patients with Imatinib- resistant/intolerant CML in chronic phase
Acronym
Multicenter clinical study of Nilotinib in CML patients with Imatinib resistance or intolerance(TSSG nilotinib-study)
Scientific Title
A phase 2 multicenter clinical study evaluating the safety and efficacy of Nilotinib in patients with Imatinib- resistant/intolerant CML in chronic phase
Scientific Title:Acronym
Multicenter clinical study of Nilotinib in CML patients with Imatinib resistance or intolerance(TSSG nilotinib-study)
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 evaluate the safety and efficacy of Nilotinib in patients with imatinib-resistant or intolerant CML-CP
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
To evaluate the rate of patients with a dose of 800 mg/day at 12 months after starting nilotinib therapy.
Key secondary outcomes
1) To evaluate the response rates at 6 and 12 months of nilotinib therapy.
2) To evaluate the response rates in imatinib-intolerant patients switched to nilotinib therapy at 6 and 12 months after starting imatinib therapy.
3) To evaluate the percentage of patients complying with the protocol treatment by the optimal dose levels at 6 and 12 months of nilotinib therapy.
4) To evaluate the safety of nilotinib
5) To assess the progression-free survival (PFS), the event-free survival (EFS), and the overall survival (OS) at 2 years.
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients with cytogenetically confirmed newly diagnosed Ph+CML-CP.
2) Patients who have not experienced a blast phase or accelerated phase of CML before treatment with Nilotinib.
3) CML-CP patients who have been treated with Imatinib for 3 months or longer and diagnosed with Imatinib resistance or intolerance.
4) ECOG performance status of 0-2.
5) Adequate end organ function.
6) Written informed concent prior to any study procedures being performed.
Key exclusion criteria
1) Patients who have received treatment with tyrosine kinase inhibitors(except for imatinib) prior to study entry.
2) Patients who are receiving treatment with other investigational agents.
3) Patients who exhibit the T315I BCR-ABL mutation.
4) Patients who have any cardiac disturbances.
5) Severe medical conditions.
6) Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of study drug.
7) Patients who are: (a)pregnant, (b)breast feeding, (c)male or female of childbearing potential unwilling to use contraceptive precautions throughout the trial.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masahiro Kizaki |
Organization
Saitama Medical Center, Saitama Medical University
Division name
Division of Hematology, Department of Internal Medicine
Zip code
Address
1981 Kamoda, Kawagoe, Saitama 350-8550, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masahiro Kizaki |
Organization
Saitama Medical Center, Saitama Medical University
Division name
Division of Hematology, Department of Internal Medicine
Zip code
Address
TEL
Homepage URL
makizaki@saitama-med.ac.jp
Sponsor or person
Institute
Tokyo STI Study Group
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
None
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 | 05 | 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
Date of protocol fixation
| 2009 | Year | 02 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2013 | 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 | 05 | Month | 01 | Day |
Last modified on
| 2009 | Year | 05 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002325
