UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001309 |
|---|---|
| Receipt number | R000001587 |
| Scientific Title | Prospective clinical study of early diagnosis and treatment for intravasclular large B-cell lymphoma (IVL) |
| Date of disclosure of the study information | 2008/08/11 |
| Last modified on | 2017/08/18 14:31:01 |
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Basic information
Public title
Prospective clinical study of early diagnosis and treatment for intravasclular large B-cell lymphoma (IVL)
Acronym
Early diagnosis and treatment for IVLBCL
Scientific Title
Prospective clinical study of early diagnosis and treatment for intravasclular large B-cell lymphoma (IVL)
Scientific Title:Acronym
Early diagnosis and treatment for IVLBCL
Region
| Japan |
Condition
Condition
Intravascular large B -cell lymphoma: IVL
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess the early clinical diagnosis and treatment of IVLBCL.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Overall survival
Key secondary outcomes
CR rate, Adverse events, Correspondence rate between early clinical diagnosis and pathological diagnosis, Diagnostic rate of bone marrow and/or random skin biopsy, Time to treatment failure
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine | Maneuver |
Interventions/Control_1
2/3 reduced dose CHOP therapy following rituximab on course 1. Standard dose R-CHOP therapy on course 2 to 6. HDC/AHST if possible.
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1, Age more than 19
2, IVL diagnosis
2-1, Pathological diagnosis
or
2-2, Early clinical diagnosis who fulfilled our criteria with bone marrow and random skin biopsy
3, Informed consent
Key exclusion criteria
1, collagen vascular disease
2, Severe infectious disease
3, Pre-treatment history for lymphoma
4, HIV+, HTLV1+ or HBV-Ag+
5, Physician's decision of inappropriateness
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasufumi Masaki |
Organization
Kanazawa Medical University
Division name
Hematology and Immunology
Zip code
Address
1-1 Daigaku, Uchinada-machi, Kahoku-gun, Ishikawa
TEL
076-286-3511
yasum@kanazawa-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasufumi Masaki |
Organization
Kanazawa Medical University
Division name
Hematology and Immunology
Zip code
Address
1-1 Daigaku, Uchinada-machi, Kahoku-gun, Ishikawa
TEL
076-286-3511
Homepage URL
http://www.kanazawa-med.ac.jp/~hematol/topics8.html
yasum@kanazawa-med.ac.jp
Sponsor or person
Institute
Department of Hematology and Immunology, Kanazawa Medical University
Institute
Department
Personal name
Funding Source
Organization
Department of Hematology and Immunology, Kanazawa Medical University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Hokuriku hematological tumor research group
Name of secondary funder(s)
self funding
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
金沢医科大学病院ほか、北陸造血器腫瘍研究会参加施設
Other administrative information
Date of disclosure of the study information
| 2008 | Year | 08 | Month | 11 | 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 | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2019 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2019 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2008 | Year | 08 | Month | 10 | Day |
Last modified on
| 2017 | Year | 08 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001587
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
