UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000007221
Receipt number R000008503
Scientific Title Multicenter Clinical Study Evaluating the Safety and Efficacy of Dasatinib Treatment and its Discontinuation in Patients with Chronic Phase Chronic Myelogenous Leukemia who had Reached Complete Molecular Response during Imatinib Therapy
Date of disclosure of the study information 2012/02/03
Last modified on 2020/12/02 14:59:14

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Basic information

Public title

Multicenter Clinical Study Evaluating the Safety and Efficacy of Dasatinib Treatment and its Discontinuation in Patients with Chronic Phase Chronic Myelogenous Leukemia who had Reached Complete Molecular Response during Imatinib Therapy

Acronym

Multicenter Clinical Study on the Safety and Efficacy of Dasatinib Discontinuation

Scientific Title

Multicenter Clinical Study Evaluating the Safety and Efficacy of Dasatinib Treatment and its Discontinuation in Patients with Chronic Phase Chronic Myelogenous Leukemia who had Reached Complete Molecular Response during Imatinib Therapy

Scientific Title:Acronym

Multicenter Clinical Study on the Safety and Efficacy of Dasatinib Discontinuation

Region

Japan


Condition

Condition

Chronic Phase Chronic Myelogenous Leukemia

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

This study is designed to evaluate the efficacy and safety of dasatinib treatment and its discontinuation in patients with chronic myelogenous leukemia in the chronic phase (CML-CP) who achieved a complete molecular response (CMR) during imatinib therapy.

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

CMR rate at 12 months after discontinuation of dasatinib treatment.

Key secondary outcomes



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

Dasatinib will be administered at 100 mg once daily for 24 months and then discontinue dasatinib therapy

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

Patients with chronic phase chronic myeloid leukemia who has been reached complete molecular response with imatinib treatment

Key exclusion criteria

1. Concurrent malignancy other than CML
2.Women who are pregnant or breastfeeding
3. A serious uncontrolled medical disorder that would impair the ability of the subjects to receive protocol therapy

Target sample size

40


Research contact person

Name of lead principal investigator

1st name Eriko
Middle name
Last name Sato

Organization

Juntendo University School of Medicine

Division name

Department of Hematology

Zip code

113-8431

Address

3-1-3 Hongo, Bunkyo-ku, Tokyo 113-8431, Japan

TEL

03-3813-3111

Email

ersato@juntendo.ac.jp


Public contact

Name of contact person

1st name Eriko
Middle name
Last name Sato

Organization

Juntendo University School of Medicine

Division name

Department of Hematology

Zip code

113-8431

Address

3-1-3 Hongo, Bunkyo-ku, Tokyo 113-8431, Japan

TEL

03-3813-3111

Homepage URL


Email

ersato@juntendo.ac.jp


Sponsor or person

Institute

Juntendo University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Juntendo University School of Medicine

Address

3-1-3 Hongo, Bunkyo-ku, Tokyo 113-8431, Japan

Tel

03-5802-1584

Email

chiken@juntendo.ac.jp


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

2012 Year 02 Month 03 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

Completed

Date of protocol fixation

2012 Year 01 Month 28 Day

Date of IRB

2012 Year 01 Month 27 Day

Anticipated trial start date

2012 Year 02 Month 01 Day

Last follow-up date

2020 Year 08 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded

2030 Year 09 Month 30 Day


Other

Other related information



Management information

Registered date

2012 Year 02 Month 03 Day

Last modified on

2020 Year 12 Month 02 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008503


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name