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Recruitment status Terminated
Unique ID issued by UMIN UMIN000002779
Receipt No. 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

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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
Email

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/
Email kyoukai@osyk.jp

Sponsor
Institute Ph Leukemia Trial Group
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003126

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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