UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000033864
Receipt No. R000037919
Scientific Title GAZYVA, Special Drug Use Surveillance -Patients with CD20-positive follicular lymphoma-
Date of disclosure of the study information 2018/10/20
Last modified on 2019/03/27

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title GAZYVA, Special Drug Use Surveillance -Patients with CD20-positive follicular lymphoma-
Acronym GAZYVA, Special Drug Use Surveillance -Patients with CD20-positive follicular lymphoma-
Scientific Title GAZYVA, Special Drug Use Surveillance -Patients with CD20-positive follicular lymphoma-
Scientific Title:Acronym GAZYVA, Special Drug Use Surveillance -Patients with CD20-positive follicular lymphoma-
Region
Japan

Condition
Condition CD20-positive follicular lymphoma
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To compare the incidence proportion of Grade >=3 infection during obinutuzumab + bendamustine combination therapy with that during other combination therapy
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The incidence proportion of Grade >=3 infection
Key secondary outcomes

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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients with CD20-positive follicular lymphoma planning to use obinutuzumab during the enrollment period.
Key exclusion criteria not applicable
Target sample size 1000

Research contact person
Name of lead principal investigator
1st name Izumi
Middle name
Last name Masaomi Nemoto
Organization Chugai Pharmaceutical Co. Ltd.
Division name Drug safety division
Zip code 1038324
Address 1-1 Nihonbashi-muromachi 2-chome, Chuo-ku Tokyo, Japan
TEL 03-3273-0905
Email nemotomst@chugai-pharm.co.jp

Public contact
Name of contact person
1st name Ayaka
Middle name
Last name Shimizu
Organization Chugai Pharmaceutical Co. Ltd.
Division name Real World Data Science Dept.
Zip code 1038324
Address 1-1 Nihonbashi-muromachi 2-chome, Chuo-ku Tokyo, Japan
TEL 03-3273-0905
Homepage URL
Email shimizuayk@chugai-pharm.co.jp

Sponsor
Institute Chugai Pharmaceutical Co. Ltd.
Institute
Department

Funding Source
Organization Chugai Pharmaceutical Co. Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization None
Address None
Tel None
Email None

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
2018 Year 10 Month 20 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
2018 Year 07 Month 31 Day
Date of IRB
Anticipated trial start date
2018 Year 10 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 CD20-positive follicular lymphoma, Obinutuzumab, Adverse events, infection

Management information
Registered date
2018 Year 08 Month 23 Day
Last modified on
2019 Year 03 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037919

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.