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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000000741
Receipt No. R000000892
Scientific Title Quantification of Epstein-Barr virus DNA in patients undergoing SMILE chemotherapy for stage IV or relapsed/refractory extranodal NK/T-cell lymphoma
Date of disclosure of the study information 2007/06/18
Last modified on 2012/06/17

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

Condition
Condition untreated stage IV or relapsed/refractory NK/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 extranodal NK/T-cell lymphoma
Basic objectives2 Others
Basic objectives -Others additional study to the phase II study of SMILE
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 (steroid, methotrexated, ifosfamide, l-asparaginase, 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 28

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuo Oshimi
Organization Juntendo University School of Medicine
Division name Department of Hematology
Zip code
Address 2-1-1 Hongo, Bunkyo-ku, Tokyo 113-8421, 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
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 Grant-in-aid of Ministry of Health, Labour and Welfare (Cancer Research), "International clinical study for NK-cell tumor among the East Asia".
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
2007 Year 06 Month 18 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://www.ncbi.nlm.nih.gov/pubmed/22675173
Number of participants that the trial has enrolled
Results PURPOSE: Extranodal NK/T-cell lymphoma, nasal type (ENKL), is an Epstein-Barr virus (EBV)-associated lymphoma for which a new chemotherapeutic regimen called SMILE (steroid, methotrexate, ifosfamide, L-asparaginase and etoposide) recently showed promising results. Experimental design: The amount of EBV-DNA was prospectively measured in whole blood and plasma samples by real-time quantitative polymerase chain reaction from 26 patients registered in the SMILE phase II study.

RESULTS: Before treatment, the EBV-DNA was detected in 22 samples of whole blood with a median number of 3,691 copies/mL (range: 0-1.14 x 107), but 15 samples of plasma with a median of 867 copies/mL (range: 0-1.27 x 107). Results of these 2 measurements of EBV-DNA well correlated (R2 = 0.994, P less than 0.001). The overall response rate to SMILE was significantly higher in patients with less than 105 copies/mL of EBV-DNA in whole blood at enrollment (90% vs. 20%, P = 0.007), and in patients with less than 104 copies/mL of EBV-DNA in plasma (95% vs. 29%, P = 0.002). The incidence of grade 4 toxicity of SMILE other than leukopenia/neutropenia was significantly higher in patients with 105 copies/mL of EBV-DNA or more in whole blood (100% vs. 35%, P = 0.007) than that of others, and in patients with 104 copies/mL or more in plasma (86% vs. 26%, P = 0.002).

CONCLUSIONS: These findings suggest that whole blood is more sensitive for clinical use than plasma. The EBV-DNA amount in whole blood was useful for predicting tumor response, toxicity and prognosis after SMILE chemotherapy for ENKL.
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 05 Month 15 Day
Date of IRB
Anticipated trial start date
2007 Year 07 Month 01 Day
Last follow-up date
2011 Year 07 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
2007 Year 06 Month 17 Day
Last modified on
2012 Year 06 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000892

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
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