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

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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 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


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

Value
https://center6.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