UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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
Title of the study (Brief title)	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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Shinichiro Okamoto
Organization	Keio University, School of Medicine
Division name	Division of Hematology
Address	Shinanomachi 35, Shinjuku-ku, Tokyo, Japan
TEL	03-3353-1211
Email	okamoto@a7.keio.jp

Public contact
Name of contact person	Kimihiro Matsumoto
Organization	Keio University School of Medicine, Division of Hematology
Division name	Hematology
Address	Shinanomachi 35, Shinjuku-ku, Tokyo, Japan
TEL	03-3353-1211
Homepage URL
Email	kmatumoto1123@gmail.com

Sponsor
Institute	Keio BRB Study group
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2011 Year 04 Month 05 Day
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

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results	http://link.springer.com/article/10.1007/s12185-015-1767-3
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.
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006632