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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000002749
Receipt No. R000003343
Scientific Title Quantification of Epstein-Barr virus DNA in patients undergoing SMILE chemotherapy for relapsed/refractory mature T-cell lymphoma
Date of disclosure of the study information 2009/11/18
Last modified on 2014/05/12

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Basic information
Public title Quantification of Epstein-Barr virus DNA in patients undergoing SMILE chemotherapy for relapsed/refractory mature T-cell lymphoma
Acronym Quantification of Epstein-Barr virus DNA in patients undergoing SMILE chemotherapy for relapsed/refractory mature T-cell lymphoma
Scientific Title Quantification of Epstein-Barr virus DNA in patients undergoing SMILE chemotherapy for relapsed/refractory mature T-cell lymphoma
Scientific Title:Acronym Quantification of Epstein-Barr virus DNA in patients undergoing SMILE chemotherapy for relapsed/refractory mature T-cell lymphoma
Region
Japan

Condition
Condition Mature T cell lymphoma
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To quantify Epstein-Barr virus (EBV)-DNA in patients undergoing phase II study of SMILE chemotherapy (Steroid, Methotrexate, Ifosfamide, L-asparaginase and Etoposide) for T-cell lymphoma
Basic objectives2 Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Disappearance rate of EBV-DNA after two cycles of the SMILE quantified by whole blood method
Key secondary outcomes Disapperance rate of EBV-DNA after completion of intended therapy, prognostic value of EBV-DNA level, comparison between two methods of EBV-DNA quantification (whole blood vs plasma)

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 SMILE chemotherapy consisting from steroid, methotrexate, ifosfamide, L-asparaginase, and etoposide.
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
15 years-old <=
Age-upper limit
69 years-old >=
Gender Male and Female
Key inclusion criteria 1) Eligible to the phase II study of SMILE
2) Written informed consent to this additional study
Key exclusion criteria none
Target sample size 42

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ritsuro Suzuki
Organization Nagoya University School of Medicine
Division name Department of HSCT Data Management & Biostatistics
Zip code
Address 1-1-20 Daiko-minami,Higashi-ku,Nagoya 461-0047,Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Ritsuro Suzuki
Organization Nagoya University School of Medicine
Division name Department of HSCT Data Management & Biostatistics
Zip code
Address
TEL
Homepage URL
Email r-suzuki@med.nagoya-u.ac.jp

Sponsor
Institute NK-cell Tumor Study Group
Institute
Department

Funding Source
Organization Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
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
2009 Year 11 Month 18 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
2009 Year 09 Month 05 Day
Date of IRB
Anticipated trial start date
2009 Year 11 Month 01 Day
Last follow-up date
2015 Year 11 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 11 Month 11 Day
Last modified on
2014 Year 05 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003343

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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