UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000004798
Receipt number R000005694
Scientific Title Discontinuation of tyrosine kinase inhibitor treatment in patients who have obtained complete molecular response after treatment with tyrosine kinase inhibitors for chronic myeloid leukemia
Date of disclosure of the study information 2011/01/05
Last modified on 2018/01/05 13:59:50

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Basic information

Public title

Discontinuation of tyrosine kinase inhibitor treatment in patients who have obtained complete molecular response after treatment with tyrosine kinase inhibitors for chronic myeloid leukemia

Acronym

Discontinuation of tyrosine kinase inhibitors for chronic myeloid leukemia

Scientific Title

Discontinuation of tyrosine kinase inhibitor treatment in patients who have obtained complete molecular response after treatment with tyrosine kinase inhibitors for chronic myeloid leukemia

Scientific Title:Acronym

Discontinuation of tyrosine kinase inhibitors for chronic myeloid leukemia

Region

Japan


Condition

Condition

Chronic myeloid leukemia

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

Evaluation of sustained complete molecular response after discontinuation of tyrosine kinase inhibitors in the treatment of chronic myeloid leukemia patients who have sustained complete molecular response for over 2 years.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Relapse of chronic myeloid leukemia after discontinuation of tyrosine kinase inihibitors

Key secondary outcomes

Change in QOL status, reduction of adverse events related to tyrosine kinase inhibitor treatment, reduction of economic burden


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

Discontinuation of tyrosine kinase inhibitor treatment

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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1) No history of AP/BC while under treatment with TKI
2) Sustained complete molecular response for over 2 years
3) Has given written informed consent
4) Is able to visit the hospital at a pre required time point

Key exclusion criteria

1) Has a history of AP/BC during TKI treatment
2) Cannot give written informed consent
3) Any patient whom the treating physician feels inappropriate for accrual

Target sample size

70


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Shinichiro Okamoto

Organization

Keio University School of Medicine

Division name

Division of Hematology

Zip code


Address

35 Shinanomachi, Shinjuku-ku, Tokyo, Japan

TEL

03-5363-3785

Email

okamoto@a7.keio.jp


Public contact

Name of contact person

1st name
Middle name
Last name Eri Matsuki

Organization

Keio University School of Medicine

Division name

Division of Hematology

Zip code


Address

35 Shinanomachi, Shinjuku-ku, Tokyo, Japan

TEL

03-5363-3785

Homepage URL


Email

erie@kk.iij4u.or.jp


Sponsor or person

Institute

Keio University School of Medicine, Division of Hematology

Institute

Department

Personal name



Funding Source

Organization

N/A

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


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 01 Month 05 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

No longer recruiting

Date of protocol fixation

2010 Year 11 Month 26 Day

Date of IRB


Anticipated trial start date

2011 Year 01 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

2010 Year 12 Month 27 Day

Last modified on

2018 Year 01 Month 05 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005694


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name