UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003499 |
|---|---|
| Receipt number | R000004242 |
| Scientific Title | Phase II clinical trial of low dose dasatinib in patients with resistant or intolerant chronic myeloid leukemia who are treated with low lose imatinib |
| Date of disclosure of the study information | 2010/04/20 |
| Last modified on | 2010/10/18 15:34:16 |
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Basic information
Public title
Phase II clinical trial of low dose dasatinib in patients with resistant or intolerant chronic myeloid leukemia who are treated with low lose imatinib
Acronym
A study of low dose dasatinib in patients with resistant or intolerant CML who are treated with low lose imatinib
Scientific Title
Phase II clinical trial of low dose dasatinib in patients with resistant or intolerant chronic myeloid leukemia who are treated with low lose imatinib
Scientific Title:Acronym
A study of low dose dasatinib in patients with resistant or intolerant CML who are treated with low lose imatinib
Region
| Japan |
Condition
Condition
Chronic myeloid leukemia patients in chronic phase who are refractory or resistant to low dose imatinib therapy.
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To explore safety and efficacy of low dose dasatinib therapy for Ph positive CML patients in chronic phase who are refractory or resistant to low dose imatinib therapy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
The ratio of patients who achieved major molecular response (MMR) after 12 months of dasatinib therapy.
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
Patients initially receive 50 mg of dasatinib, and then the dose will be up to 100mg.
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
Inclusion Criteria:
Signed Written Informed Consent
Subjects with chronic phase chronic myeloid leukemia (CML)
Subjects resistant/intolerant to imatinib less or equal than 200mg
Subjects presenting:
1.ECOG performance status (PS) score 0-2
2.Adequate hepatic function
3.Adequate renal function
4.Adequate lung function
Exclusion Criteria:
Concurrent malignancy other than CML
Women who are pregnant or breastfeeding
Concurrent pleural effusion
Uncontrolled or significant cardiovascular disease
A serious uncontrolled medical disorder that would impair the ability of the subjects to receive protocol therapy.
Prior therapy with dasatinib
Subjects with T315I and/or F317L BCR-ABL point mutations
Key exclusion criteria
Exclusion Criteria:
Concurrent malignancy other than CML
Women who are pregnant or breastfeeding
Concurrent pleural effusion
Uncontrolled or significant cardiovascular disease
A serious uncontrolled medical disorder that would impair the ability of the subjects to receive protocol therapy.
Prior therapy with dasatinib
Subjects with T315I and/or F317L BCR-ABL point mutations
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hisashi Sakamaki |
Organization
Tokyo Metropolitan Cancer and Infectious Diseases Center, Komagome Hospital, Tokyo, Japan.
Division name
Vice director
Zip code
Address
3-18-22 Honkomagome Bunkyo-ku Tokyo 1138677
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuteru Ohashi |
Organization
Tokyo Metropolitan Cancer and Infectious Diseases Center, Komagome Hospital, Tokyo, Japan.
Division name
Hematology Division
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
Kanto CML Study Group
Institute
Department
Personal name
Funding Source
Organization
Epidemiological and Clinical Research Information Network (ECRIN)
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
| 2010 | Year | 04 | Month | 20 | 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
Enrolling by invitation
Date of protocol fixation
| 2010 | Year | 04 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 04 | 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
| 2010 | Year | 04 | Month | 16 | Day |
Last modified on
| 2010 | Year | 10 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004242
