UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005613 |
|---|---|
| Receipt number | R000006632 |
| Scientific Title | Clinical PhII Study: Investigation for safety and efficacy of bendamustine and rituximab, B-R combination therapy for the patients of recurrent and/or refractory low-grade B cell lymphoma or mantle cell lymphoma previously treated with one or two regimen including rituximab |
| Date of disclosure of the study information | 2011/05/20 |
| Last modified on | 2016/05/07 00:43:46 |
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Basic information
Public title
Clinical PhII Study: Investigation for safety and efficacy of bendamustine and rituximab, B-R combination therapy for the patients of recurrent and/or refractory low-grade B cell lymphoma or mantle cell lymphoma previously treated with one or two regimen including rituximab
Acronym
BRB Study
Scientific Title
Clinical PhII Study: Investigation for safety and efficacy of bendamustine and rituximab, B-R combination therapy for the patients of recurrent and/or refractory low-grade B cell lymphoma or mantle cell lymphoma previously treated with one or two regimen including rituximab
Scientific Title:Acronym
BRB Study
Region
| Japan |
Condition
Condition
Relapsed and/or refractory low-grade B cell non-Hodgkin lymphoma
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate for safety and efficacy of bendamustine and rituximab, B-R combination therapy up to 4 cycles for the patients of reccurent and/or refractory low-grade B cell lymphoma previously treated
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Overall response rate (best response)
Key secondary outcomes
Adverse events
Complete response rate
TTP
OS
HT rate
SPM rate
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
1st cycle; Administrate Rituximab 375mg/m2 DIV for d1 and Bendamustine 90 mg/m2 DIV for d 2 and d 3 and observe for 25 ds.
2nd to 4th cycle; Rituximab 375mg/m2 DIV d1 and Bendamustine 90 mg/m2 DIV d1 and d2 and observe for 26 ds.
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. Low-grade B cell non-Hodgkin lymphoma pts confirmed with histology or cytology
2. Pt who were previously treated with 1 or 2 regimen including rituximab
3. Refractory or recurrent disease pts
4. CD20 positive
5. Mesureable disease
6. ECOG performance status 0-2
7. ANC=1500 or more, Hb=9.0 or more, Platelet count=100000 or more, AST, ALT, and ALP less than 2.5XUL, TB and Cr less than 1.5XUL
8. Normal ECG or asymptomatic minor ECG change
9. Expected surviaval time more than 3 M
10.Written informed consent obtained
Key exclusion criteria
1. Pregnancy, brest-feedings, or pts who would be pregnant
2. Active double cancer
3. Psychotics judged could not be difficutlt to attend
4. Severe complication and/or infection
5. Liver cirrhosis
6. Interstitial pneumonitis
7. Tumor cells in PB are 25000/uL or more
8. CNS invasion
9. Past history of bendamustine administration
10.Inappropriate to administer rituximab
11.Sever hypersensitity on any agents
12.Judged to be inappropriate
Target sample size
44
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinichiro Okamoto |
Organization
Keio University, School of Medicine
Division name
Division of Hematology
Zip code
Address
Shinanomachi 35, Shinjuku-ku, Tokyo, Japan
TEL
03-3353-1211
okamoto@a7.keio.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kimihiro Matsumoto |
Organization
Keio University School of Medicine, Division of Hematology
Division name
Hematology
Zip code
Address
Shinanomachi 35, Shinjuku-ku, Tokyo, Japan
TEL
03-3353-1211
Homepage URL
kmatumoto1123@gmail.com
Sponsor or person
Institute
Keio BRB Study group
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
慶應義塾大学病院（東京都）、杏林大学病院（東京都）、横浜市立市民病院（神奈川県）、東京医療センター（東京都）、永寿総合病院（東京都）、済生会中央病院（東京都）、川崎市立川崎病院（神奈川県）、東京歯科大学市川総合病院（千葉県）、けいゆう病院（神奈川県）、済生会宇都宮病院（栃木県）、立川病院（東京都）、東京電力病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 05 | Month | 20 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
http://link.springer.com/article/10.1007/s12185-015-1767-3
Number of participants that the trial has enrolled
Results
Fifty-three patients were enrolled in this study and analyzed. The diagnosis included follicular lymphoma (FL) (77 %), mucosa-associated lymphoid tissue lymphoma (13 %) and others (10 %). Forty-seven (90 %) patients completed four cycles of treatment as per schedule. Best overall response rate (ORR) and complete response rate (CRR) was 94 and 71 %, respectively (for FL, ORR 95 % and CRR 80 %). The treatment was well tolerated and the primary toxicity was myelosuppression; the incidence of grade 3/4 leukopenia and neutropenia were 42 and 40 %, respectively. There were no grade 5 toxicities. For the evaluation of late toxicity, especially infection, longer follow-up of this cohort is needed.
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
Terminated
Date of protocol fixation
| 2011 | Year | 04 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
| 2016 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2016 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 05 | Month | 17 | Day |
Last modified on
| 2016 | Year | 05 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006632
