UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015734 |
|---|---|
| Receipt number | R000018309 |
| Scientific Title | A prospective study of cytomegalovirus reactivation in hematological patients treated with bendamustine |
| Date of disclosure of the study information | 2014/11/21 |
| Last modified on | 2014/11/21 17:05:08 |
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Basic information
Public title
A prospective study of cytomegalovirus reactivation in hematological patients treated with bendamustine
Acronym
BendaCMV study
Scientific Title
A prospective study of cytomegalovirus reactivation in hematological patients treated with bendamustine
Scientific Title:Acronym
BendaCMV study
Region
| Japan |
Condition
Condition
B-cell lymphoma
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Analysis of the effect of immunosuppression induced by the treatment with bendamustine
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Analysis of reactivation of cytomegalovirus in patients treated with bendamustine
Key secondary outcomes
Analysis of CMV specific T lymphocytes
Analysis of the effect of immunosuppression after bendamustine
Analysis of side effect induced by antiviral drug
Base
Study type
Observational
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
patients who gave written informed consent abotu this study
Key exclusion criteria
1.active infection
2.primary immunodeficiency,
3.AIDS
4.past history of hematopoietic transplantation
5.female patients who are breast feeding or pregnant.
6.Uncontrollable psychiatric illness
7.past history of reactivation of cytomegalovirus
8.CMV IgG negative patients
9.patients who, in the judgment of the investigator, would be inappropriate for entry into this study
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshinobu Kanda |
Organization
Saitama Medical Center, Jichi Medical University
Division name
Division of Hematology
Zip code
Address
1-847,Amanuma-cho, Omiya, Saitama
TEL
048-647-2111
ycanda-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ugai Tomotaka |
Organization
Saitama Medical Center, Jichi Medical University
Division name
Division of Hematology
Zip code
Address
1-847,Amanuma-cho, Omiya, Saitama
TEL
048-647-2111
Homepage URL
harukakanata58@yahoo.co.jp
Sponsor or person
Institute
Saitama Medical Center, Jichi Medical University
Institute
Department
Personal name
Funding Source
Organization
Saitama Medical Center, Jichi Medical University
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
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
自治医科大学附属さいたま医療センター（埼玉県）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 11 | Month | 21 | 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
Open public recruiting
Date of protocol fixation
| 2014 | Year | 11 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 11 | Month | 22 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
before anticipation
Management information
Registered date
| 2014 | Year | 11 | Month | 21 | Day |
Last modified on
| 2014 | Year | 11 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018309
