UMIN-CTR Clinical Trial

Basic information
Public title	Phase II study of Bendamustine-Rituximab therapy for CD20-positive untreated and advanced follicular lymphoma with poor response to R-CHOP therapy
Acronym	Bendamustine Convert Study
Scientific Title	Phase II study of Bendamustine-Rituximab therapy for CD20-positive untreated and advanced follicular lymphoma with poor response to R-CHOP therapy
Scientific Title:Acronym	Bendamustine Convert Study
Region	Japan

Condition
Condition	untreated and advanced follicular 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 6 cycles for the patients of CD20-positive untreated and advanced follicular lymphoma with poor response to R-CHOP therapy
Basic objectives2	Others
Basic objectives -Others	Exploratory endpoints were to investigate clinical prognostic factors in this trial. As a validation cohort, we reviewed and collected the medical records of 100 pts with treatment-naive FL or relapsed FL after R-CHOP who were treated with R-B from 2010 to 2020
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	Progression free survival rate of 3 years of BR therapy enforcement group
Key secondary outcomes	1) Response rate 2) Complete response rate 3)Progression free survival (the median) 4) Safety (Adverse events) 5) Convalescence prediction factor of follicular lymphoma 6) Overall survival 7) histological transformation

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	The R-CHOP treatment 1 2 cycles 2 cycles of R-CHOP treatments are enforced as three-week one cycle. RituximubDay1375mg/m2/DayDiv Cyclophosphamids750mg/m2/dayDiv Doxorvicin50mg/m2/dayIv Vincristin1.4mg/m2/dayIv(Max.2.0mg/body)po/i Predonisolon100mg/body/dayv Filgrastim75ug/bodySc CT is enforced among day+15-21 of the 2nd cycles. An effect judging is judged based on the visual assessment of CT.poor response group (BR treatment group)B-Rcombination therapy up to 6 cycles. RituximabDay1 375mg/m2/dayDiv BendamustineDay2Day390mg/m2Div
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	85 years-old >
Gender	Male and Female
Key inclusion criteria	1)Advance term (Ann Arbor stage III/IV) follicular lymphoma or stage II with a bulky disease of 7 cm or more (or 1.B cell non-Hodgkin's lymphoma, 2.Intermediate-high risk of FLIPI2 index 3.Treatment is required ) 2) Histologically confirmed CD20 positive B cell non-Hodgkin's lymphoma (follicular lymphoma: Grade 1-3a) 3) Mesureable disease (Major-axis:> 1.5 cm by CT) 4)age20-85 5)Performance Status (ECOG)0-2 6)Adequate organ function 7)No severe complications 8)Expected at least 3 months survival 9)Written informed consent obtained
Key exclusion criteria	1)Any other active malignancies 2)Uncontrollable serious complications (diabetes, heart failure, cardiomyopathy, abnormal heart rhythm, angina, myocardial infarction, interstitial pneumonia, pulmonary fibrosis, radiation pneumonia, infection, a respiratory failure, an organic lung disease, hepatic insufficiency, liver cirrhosis, acute chronic hepatitis, renal insufficiency, etc.) patients with active tuberculosis 3)Circulating lymphoma cells >= 25,000 /uL in peripheral blood 4)Primary central nervous system lymphoma or central nervous system invasion 5)Anaphylactic shock for any drugs 6)The HCV antibody-positive 7)Inappropriate for rituximab treatment 8)Serious mental disorder, such as schizophrenia 9)Diagnosed as a malignant lymphoma, leukemia, and myelodysplastic syndromes in the past 10)The treatment history of the chemotherapy, the radiotherapy, cytokine therapy, and antibody therapy to FL 11)Pregnant/female patients who are unwilling to take prevention measures for contraception during treatment 12)HIV antibody-positive 13)Inappropriate for entry by physician's decision
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Yoichi Middle name Last name Tatsumi
Organization	Kinki University Faculty of Medicine
Division name	Department of Hematology and Rheumatology,
Zip code	589-8511
Address	OSAKA SAYAMA CITY OONOHIGASHI377-2
TEL	0723660221
Email	rai@med.kindai.ac.jp

Public contact
Name of contact person	1st name youichi Middle name Last name tatsumi
Organization	Kinki University Faculty of Medicine
Division name	Department of Hematology and Rheumatology,
Zip code	5898511
Address	OSAKA SAYAMA CITY OONOHIGASHI377-2
TEL	072-366-0221
Homepage URL
Email	inter-3@med.kindai.ac.jp

Sponsor
Institute	Department of Hematology and Rheumatology,Kinki University Faculty of Medicine
Institute
Department

Funding Source
Organization	Department of Hematology and Rheumatology,Kinki University Faculty of Medicine
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	HyogoCRB
Address	Nishinomiya city mukogawa cho 1-1
Tel	0798456111
Email	rinken@hyo-med.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	2014 Year 04 Month 24 Day

Related information
URL releasing protocol
Publication of results	Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled	60
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results	2021 Year 08 Month 17 Day
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Main results already published
Date of protocol fixation	2013 Year 03 Month 08 Day
Date of IRB	2013 Year 03 Month 08 Day
Anticipated trial start date	2013 Year 06 Month 01 Day
Last follow-up date	2022 Year 03 Month 31 Day
Date of closure to data entry	2022 Year 03 Month 31 Day
Date trial data considered complete	2022 Year 03 Month 31 Day
Date analysis concluded	2022 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date	2014 Year 04 Month 23 Day
Last modified on	2021 Year 10 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000016103