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


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

06-6976-2071

Homepage URL


Email



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


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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name