UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000001151
Receipt number R000001367
Scientific Title Randomized controlled trial to compare cyclosporine and tacrolimus for GVHD prophylaxis after unrelated bone marrow transplantation
Date of disclosure of the study information 2008/05/12
Last modified on 2014/05/12 09:12:28

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Basic information

Public title

Randomized controlled trial to compare cyclosporine and tacrolimus for GVHD prophylaxis after unrelated bone marrow transplantation

Acronym

RCT to compare CsA and FK506 for GVHD prophylaxis after unrelated BMT

Scientific Title

Randomized controlled trial to compare cyclosporine and tacrolimus for GVHD prophylaxis after unrelated bone marrow transplantation

Scientific Title:Acronym

RCT to compare CsA and FK506 for GVHD prophylaxis after unrelated BMT

Region

Japan


Condition

Condition

acute leukemia or myelodysplastic syndrome

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the efficacy and toxicity of CsA and FK506 administered at appropriate blood concentration after unrelated BMT.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase III


Assessment

Primary outcomes

Success difined as 1) alive at day 100, 2) absence of grade II-IV acute GVHD, 3) discontinuation of assigned immunosuppressant, and 4) use of steroid.

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Medicine

Interventions/Control_1

cyclosporine

Interventions/Control_2

tacrolimus

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

16 years-old <=

Age-upper limit

55 years-old >=

Gender

Male and Female

Key inclusion criteria

Patients aged between 16 and 55 years old with acute leukemia or myelodysplastic syndrome who undergo unrelated BMT

Key exclusion criteria

Uncontrolled DM, HTN, and so on.

Target sample size

110


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Shinichiro Okamoto

Organization

KSGCT

Division name

Chairman

Zip code


Address

Tokyo

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

KSGCT

Division name

Trial office

Zip code


Address


TEL


Homepage URL


Email

ycanda-tky@umin.ac.jp


Sponsor or person

Institute

KSGCT

Institute

Department

Personal name



Funding Source

Organization

KSGCT

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

2008 Year 05 Month 12 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

2007 Year 09 Month 13 Day

Date of IRB


Anticipated trial start date

2008 Year 01 Month 01 Day

Last follow-up date

2012 Year 12 Month 01 Day

Date of closure to data entry

2014 Year 05 Month 01 Day

Date trial data considered complete

2014 Year 06 Month 01 Day

Date analysis concluded

2014 Year 08 Month 01 Day


Other

Other related information



Management information

Registered date

2008 Year 05 Month 12 Day

Last modified on

2014 Year 05 Month 12 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001367


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name