UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006346 |
|---|---|
| Receipt number | R000007485 |
| Scientific Title | Phase II clinical trial of dasatinib in newly diagnosed chronic phase chronic myelogenous leukemia |
| Date of disclosure of the study information | 2011/10/01 |
| Last modified on | 2014/05/19 09:43:40 |
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Basic information
Public title
Phase II clinical trial of dasatinib in newly diagnosed chronic phase chronic myelogenous leukemia
Acronym
Phase II trial of dasatinib for newly diagnosed CP-CML.
Scientific Title
Phase II clinical trial of dasatinib in newly diagnosed chronic phase chronic myelogenous leukemia
Scientific Title:Acronym
Phase II trial of dasatinib for newly diagnosed CP-CML.
Region
| Japan |
Condition
Condition
newly diagnosed chronic myelogenous leukemia in chronic phase
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To explore safety and efficacy of Dasatinib therapy for newly diagnosed Chronic Myelogenous Leukemia in chronic phase.
Basic objectives2
Safety,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
(1) MMR rate at 6 months after the treatment.
(2) CMR rate at 12 months after the treatment.
(3) CCyR rate
(4) The correlation of LGL expression and the MMR rate.
(5) The correlation of LGL expression and onset of pleural effusion.
(6) The examination of the optimal administration schedule.
(7) The frequencies of adverse events Grade3 or more.
(8) Event Free Survival(EFS)
(9) Overall Survival (OS)
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
Administer Dasatinib 100mg/day parenterally.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) CP-CML
Blast < 15%
Blast + promyelocyte < 30%
Basophils in peripheral blood <20%
Platelet >= 100x10^9/L
(2) 20 years old or older
(3) ECOG performance status 0~2
(4) Normal organ function(liver, kidney, lung) as indicated as follows;
AST and ALT < 1.5xULN or Total bilirubin < 5xULN.
Serum creatinine < 1.5xULN.
Neutrophil count >=1,000/mcl
Platelet >= 50,000/mm3
(5) A hydroxycarbamide use case for the purpose of the blood corpuscle control. (Duration of use is principle less than two weeks.)
(6) The patients that is able to obtain written informed consent for the trial.
Key exclusion criteria
Patients who are true with either of the followings are excluded;
(1) A case with the double cancer of the activity.
(2) Females during pregnancy or lactation.
(3) Patients with no will or capability to use appropriate birth control during the trial.
(4) Other serious past disease history or present concomitant diseases that are considered inappropriate to conduct this trial.
(5) Past history of tyrosine kinase inhibitor therapy.
(6) The patients of accelerated phase or blast phase clearly.
(7) The patients with positive one of HBs antigen, HCV antibody, HIV antibodies
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mineo Kurokawa |
Organization
The University of Tokyo Hospital
Division name
Dep. of Hematology/Oncology
Zip code
Address
113-8655 Hongo 7-3-1 Bunkyo-ku Tokyo,Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Ph leukemia trial Group
Division name
Ph leukemia trial Group
Zip code
Address
TEL
06-6976-2071
Homepage URL
Sponsor or person
Institute
Ph leukemia trial Group
Institute
Department
Personal name
Funding Source
Organization
Ph leukemia trial Group
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
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
| 2011 | Year | 10 | 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
Terminated
Date of protocol fixation
| 2011 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 10 | 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
| 2011 | Year | 09 | Month | 14 | Day |
Last modified on
| 2014 | Year | 05 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007485
