UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007110 |
|---|---|
| Receipt number | R000008375 |
| Scientific Title | Analysis of Rituximab intensification therapy for low grade B-cell lymphoma refractory to Bendamustine |
| Date of disclosure of the study information | 2012/01/27 |
| Last modified on | 2022/09/28 16:01:43 |
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Basic information
Public title
Analysis of Rituximab intensification therapy for low grade B-cell lymphoma refractory to Bendamustine
Acronym
Bendamustine intensification therapy for low grade B-cell lymphoma refractory to Bendamustine
Scientific Title
Analysis of Rituximab intensification therapy for low grade B-cell lymphoma refractory to Bendamustine
Scientific Title:Acronym
Bendamustine intensification therapy for low grade B-cell lymphoma refractory to Bendamustine
Region
| Japan |
Condition
Condition
low grade B-cell lymphoma
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To examine whether the response ratio of low grade B-cell lymphoma refractory to Bendamustine will be improved by Rituximab intensification therapy.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
response ratio
Key secondary outcomes
progression free survival and safety
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Rituximab intensification in case of partial response or stable disease
Interventions/Control_2
observation in case of complete remission
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Relapse and refractory low grade B-cell lymphoma patients who will be treated with Bendamustine. Their hepatic and renal functions should be normal.
Key exclusion criteria
1. for whom Bendamustine is contraindication
2. with liver cirrhosis
3. with severe mental disability
4. pregnant or possible to be pregnant
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Junji Tanaka |
Organization
Tokyo women's medical university
Division name
department of hematology
Zip code
Address
8-1 Kawada-cho, Shinjuku-ku, Tokyo, Japan
TEL
03-3353-8111
jutanaka@dh.twmu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoichi Imai |
Organization
Tokyo women's medical university
Division name
department of hematology
Zip code
Address
8-1 Kawada-cho, Shinjuku-ku, Tokyo, Japan
TEL
03-3353-8111
Homepage URL
imaiyo@dh.twmu.ac.jp
Sponsor or person
Institute
Tokyo women's medical university
Institute
Department
Personal name
Funding Source
Organization
Tokyo women's medical university
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
Address
Tel
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
| 2012 | Year | 01 | Month | 27 | 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
| 2011 | Year | 01 | Month | 24 | Day |
Date of IRB
| 2012 | Year | 01 | Month | 01 | Day |
Anticipated trial start date
| 2012 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 01 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 01 | Month | 20 | Day |
Last modified on
| 2022 | Year | 09 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008375
