UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002779 |
|---|---|
| Receipt number | R000003126 |
| Scientific Title | Phase II clinial trial of Dasatinib for Imatinib resistant or refractory chronic myeloid leukemia in chronic phase. |
| Date of disclosure of the study information | 2009/12/01 |
| Last modified on | 2014/08/05 09:25:57 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Phase II clinial trial of Dasatinib for Imatinib resistant or refractory chronic myeloid leukemia in chronic phase.
Acronym
Phase II trial of Dasatinib for Imatinib resistant/refractory CML in CP.
Scientific Title
Phase II clinial trial of Dasatinib for Imatinib resistant or refractory chronic myeloid leukemia in chronic phase.
Scientific Title:Acronym
Phase II trial of Dasatinib for Imatinib resistant/refractory CML in CP.
Region
| Japan |
Condition
Condition
Chronic myeloid leukemia patients in chronic phase who are refractory or resistant to 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 Dasatinib therapy for Ph positive CML patients in chronic phase who are refractory or resistant to 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 complete cytogenetic response (CCyR) after 12 months of Dasatinib therapy.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
@ECOG performance status 0~2.
@Normal organ (liver, kidney, lung) function as indicated as follows;
AST or ALT < 5xULN
T.Bil < 3xULN
cre < 3xULN
Neutrophil counts >=1,000/microL
Platelet counts >= 50,000/mm3
Body temperature < 37.5 degrees
PaO2>=60mmHg or SpO2>=93% (room air)
@Able to obtain written informed consent for the trial.
Key exclusion criteria
Patients who are true with either of the followings are excluded;
@Females in childbearing years with no will or capability to use appropriate birth control during the trial.
@Females during pregnancy or lactation.
@Male patients with no will or capability to use appropriate birth control during the trial.
@Past history or concomitant cardiovascular diseases that are serious or poorly-controlled.
@Other serious past disease history or present concomitant diseases that are considered inappropriate to condcut this trial.
@Active infectious diseases, or Other malignancies, or HBV/HIV infection.
@Pasthistory of Dasatinib therapy.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kanamaru Akihisa |
Organization
Kinki University, School of Medicine
Division name
Division of Hematology
Zip code
Address
Ohno Higashi 377-2, Ohsaka Sayamashi, Ohsaka, Japan
TEL
072-366-0221
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
06-6976-2081
Homepage URL
http://www.ph1st.jp/
kyoukai@osyk.jp
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
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 | 12 | Month | 01 | Day |
Related information
URL releasing protocol
http://www.ph1st.jp
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
| 2009 | Year | 03 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The object of this study is to observe the effeciveness and safety of Dasatinib therapy for Imatinib-resistant / refractory chronic phase CML.
Management information
Registered date
| 2009 | Year | 11 | Month | 19 | Day |
Last modified on
| 2014 | Year | 08 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003126
