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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001309
Receipt No. 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

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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
Email 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
Email yasum@kanazawa-med.ac.jp

Sponsor
Institute Department of Hematology and Immunology, Kanazawa Medical University
Institute
Department

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
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 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
URL(English) https://upload.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
Registered date File name


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