UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032309 |
|---|---|
| Receipt number | 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 | 2022/02/09 13:44:56 |
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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
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
miura.katsuhiro@nihon-u.ac.jp
Sponsor or person
Institute
Nihon University Itabashi Hospital
Institute
Department
Personal name
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
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
Published
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
Completed
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
| 2021 | 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
| 2022 | Year | 02 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036505
