UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000010846
Receipt number R000012702
Scientific Title Japan Azacitidine Reserch For CMML study
Date of disclosure of the study information 2013/05/31
Last modified on 2018/01/04 16:09:00

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Basic information

Public title

Japan Azacitidine Reserch For CMML study

Acronym

JARC study

Scientific Title

Japan Azacitidine Reserch For CMML study

Scientific Title:Acronym

JARC study

Region

Japan


Condition

Condition

Chronic myelomonocytic leukemia

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To investigate the efficacy and prognostic factor in Azacitidine treatment for chronic myelomonocytic leukemia.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Overall survival,
Response rates in IWG2006 response criteria.

Key secondary outcomes



Base

Study type

Others,meta-analysis etc


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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients who received azacitidine between March 2011 and October 2012.

Key exclusion criteria

None

Target sample size

40


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kensuke Usuki

Organization

NTT Medical Center Tokyo

Division name

Department of Hematoglogy

Zip code


Address

Higashi-Gotanda 5-9-22, Shinagawa-ku, Tokyo, Japan Zip code 141-8625

TEL

03-3448-6111

Email

kensuke.usuki@gmail.com


Public contact

Name of contact person

1st name
Middle name
Last name Kensuke Usuki

Organization

NTT Medical Center Tokyo

Division name

Department of Hematoglogy

Zip code


Address

Higashi-Gotanda 5-9-22, Shinagawa-ku, Tokyo, Japan Zip code 141-8625

TEL

03-3448-6111

Homepage URL


Email

kensuke.usuki@gmail.com


Sponsor or person

Institute

MDS study group

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


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

2013 Year 05 Month 31 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

2012 Year 09 Month 11 Day

Date of IRB


Anticipated trial start date

2012 Year 11 Month 15 Day

Last follow-up date

2013 Year 06 Month 14 Day

Date of closure to data entry

2015 Year 11 Month 30 Day

Date trial data considered complete

2015 Year 11 Month 30 Day

Date analysis concluded

2015 Year 12 Month 28 Day


Other

Other related information

Multi-institutional retrospective observational study.


Management information

Registered date

2013 Year 05 Month 31 Day

Last modified on

2018 Year 01 Month 04 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012702


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name