UMIN-CTR Clinical Trial

Basic information
Public title	Phase II study of bendamustine, rituximab and cytarabine for patients with relapsed or refractory follicular lymphoma or mantle cell lymphoma
Acronym	GHSG-BRAC
Scientific Title	Phase II study of bendamustine, rituximab and cytarabine for patients with relapsed or refractory follicular lymphoma or mantle cell lymphoma
Scientific Title:Acronym	GHSG-BRAC
Region	Japan

Condition
Condition	relapsed or refractory follicular lymphoma or mantle cell lymphoma
Classification by specialty	Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	To evaluate efficacy and safety of bendamustine, rituximab and cytarabine for treatment of relapsed or refractory follicular lymphoma or mantle cell lymphoma.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	complete response rate
Key secondary outcomes	overall response rate event free survival progression free survival safty peripheral blood stem cell harvest (transplant case)

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	BRAC therapy Rituximab 375mg/sqm Day 1 Bendamustine 90mg/sqm Day 2,3 Cytarabine 600mg/sqm Day 2,3,4 Filgrastim 300ug/m2/day sc after Day 5
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) Patients with pathologically confirmed follicular lymphoma or mantle cell lymphoma. 2) Patients had received prior treatment of rituximab in combination with chemotherapy or rituximab alone, and were considered no response or relapse after CR or PR. 3) CD20 positive. 4) Patients have measurable lesion that measured >=1.5cm in a single dimension by CT. 5) Patients aged 20-80 years. 6) PS(ECOG) 0-2 7) Patients meet all following standard Absolute neutrophil count >= 1,000/mm3 Hemoglobin >= 8.0 g/dL Platelet count >= 75,000/mm3 AST and ALT < 2.5 times facility criteria. Total bilirubin < 2.5 times facility criteria. Creatinine < 1.5 times facility criteria. Cardiac electro gram: no abnormality required treatment 8) Patients have a life expectancy > 3 months. 9) Written informed consent.
Key exclusion criteria	1) Patients are pregnant or lactating women. Patients (<1 year after menopause without surgical infertility) can not or will not use birth control during the treatment. 2) Patients have active other malignant diseases including simultaneous cancer and disease free state within 5 years after treatment for other cancer except curable intramural cancer by local treatment. 3) Patients have mental disease or disorder with difficulty in participating in the clinical trial. 4) HIV antibody positive, HBs antigen positive, HCV antibody positive 5) Patients have much tumor cell in peripheral blood (>=25,000/mm3). 6) Patients received allogeneic hematopoietic stem cell transplant. 7) Patients have interstitial lung disease or fibroid lung. 8) Patients have CNS invasion. 9) Patients are inappropriate for rituximab treatment. 10) Patients have severe allergic symptoms. 11) Inadequate for clinical trial entry by the attending physicians.
Target sample size	27

Research contact person
Name of lead principal investigator	1st name Nobuhiro Middle name Last name Kanemura
Organization	Gifu University Hospital
Division name	First Department of Internal Medicine
Zip code	501-1194
Address	1-1 Yanagido Gifu
TEL	058-230-6008
Email	nkane@orion.ocn.ne.jp

Public contact
Name of contact person	1st name Nobuhiko Middle name Last name Nakamura
Organization	Gifu University Hospital
Division name	First Department of Internal Medicine
Zip code	501-1194
Address	1-1 Yanagido Gifu
TEL	058-230-6008
Homepage URL
Email	nnakamura-gif@umin.ac.jp

Sponsor
Institute	Gifu University Hospital
Institute
Department

Funding Source
Organization	First Department of Internal Medicine, Gifu University Hospital
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	Gifu University Institutional Review Board
Address	1-1 Yanagido Gifu
Tel	058-230-6008
Email	rinri@gifu-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	岐阜市民病院（岐阜県）、岐阜赤十字病院（岐阜県）

Other administrative information
Date of disclosure of the study information	2013 Year 01 Month 17 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications	https://ehoonline.biomedcentral.com/articles/10.1186/s40164-022-00264-3
Number of participants that the trial has enrolled	13
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results	2022 Year 02 Month 25 Day
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Terminated
Date of protocol fixation	2012 Year 07 Month 09 Day
Date of IRB	2012 Year 07 Month 09 Day
Anticipated trial start date	2012 Year 10 Month 01 Day
Last follow-up date	2021 Year 03 Month 20 Day
Date of closure to data entry	2021 Year 03 Month 20 Day
Date trial data considered complete	2021 Year 03 Month 20 Day
Date analysis concluded	2021 Year 03 Month 20 Day

Other
Other related information

Management information
Registered date	2013 Year 01 Month 17 Day
Last modified on	2022 Year 03 Month 01 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011103