UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Prospective clinical study of early diagnosis and treatment for intravasclular large B-cell lymphoma (IVL)
Title of the study (Brief title)	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	Yasufumi Masaki
Organization	Kanazawa Medical University
Division name	Hematology and Immunology
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	Yasufumi Masaki
Organization	Kanazawa Medical University
Division name	Hematology and Immunology
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

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

Progress
Recruitment status	Completed
Date of protocol fixation	2007 Year 03 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000001587