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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000032309
Receipt No. R000036505
Scientific Title Frequency of occurrence by risk-based response to infusion reaction upon rituximab administration in patients with B-cell non-Hodgkin's lymphoma
Date of disclosure of the study information 2018/04/19
Last modified on 2020/04/23

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Basic information
Public title Frequency of occurrence by risk-based response to infusion reaction upon rituximab administration in patients with B-cell non-Hodgkin's lymphoma
Acronym Frequency of occurrence by risk-based response to infusion reaction upon rituximab administration in patients with B-cell non-Hodgkin's lymphoma
Scientific Title Frequency of occurrence by risk-based response to infusion reaction upon rituximab administration in patients with B-cell non-Hodgkin's lymphoma
Scientific Title:Acronym Frequency of occurrence by risk-based response to infusion reaction upon rituximab administration in patients with B-cell non-Hodgkin's lymphoma
Region
Japan

Condition
Condition B-cell non-Hodgkin's lymphoma
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Reduce the frequency of occurrence due to risk-based response to infusion reaction upon administration of rituximab in patients with B-cell non-Hodgkin's lymphoma
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Incidence rate of infusion reaction in each risk group at the time of initial administration of rituximab
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Patients with low-grade lymphoma (-), bulky mass (> 10 cm) (-) are administered rituximab at normal rates.
Interventions/Control_2 Patients with low-grade lymphoma (+), bulky mass (tumor size> 10 cm) (-) or low-grade lymphoma (-), bulky mass (tumor diameter> 10 cm) (+), prophylactic administration of corticosteroids Rituximab is administered at normal rate.
Interventions/Control_3 Patients with low-grade lymphoma (+), bulky mass (> 10 cm) (+) are administered prophylactic corticosteroids, and rituximab is administered at the maximum administration rate.
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 B cell non-Hodgkin lymphoma patients
Key exclusion criteria Patients who have been treated with rituximab in the past
Target sample size 70

Research contact person
Name of lead principal investigator
1st name Tatsuya
Middle name
Last name Hayama
Organization Nihon University Itabashi Hospital
Division name Department of pharmacy
Zip code 173-8610
Address 30-1 Oyaguchikami-cho, Itabashi ward, Tokyo
TEL 03-3972-8111
Email hayama.tatsuya@nihon-u.ac.jp

Public contact
Name of contact person
1st name Katsuhiro
Middle name
Last name Miura
Organization Nihon University School of Medicine
Division name Department of Hematology and Rheumatology
Zip code 173-8610
Address 30-1 Oyaguchikami-cho, Itabashi ward, Tokyo
TEL 03-3972-8111
Homepage URL
Email miura.katsuhiro@nihon-u.ac.jp

Sponsor
Institute Nihon University Itabashi Hospital
Institute
Department

Funding Source
Organization None
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 Nihon University Itabashi Hospital
Address 30-1 Oyaguchikami-cho, Itabashi ward, Tokyo
Tel 03-3972-8111
Email med.itabashi.chiken@nihon-u.ac.jp

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 04 Month 19 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 83
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 No longer recruiting
Date of protocol fixation
2018 Year 03 Month 28 Day
Date of IRB
2018 Year 03 Month 14 Day
Anticipated trial start date
2018 Year 04 Month 01 Day
Last follow-up date
2022 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 04 Month 18 Day
Last modified on
2020 Year 04 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036505

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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