UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000741 |
|---|---|
| Receipt number | 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 10:26:26 |
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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
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
r-suzuki@med.nagoya-u.ac.jp
Sponsor or person
Institute
NK-cell Tumor Study Group
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000892
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