UMIN-CTR Clinical Trial

Basic information
Public title	Evaluation on efficacy and safety of a combination therapy of rituximab with bendamustin in the patients with relapsed or resistnat low grade B-cell non-Hodgkin lymphoma
Acronym	Evaluation on efficacy and safety of a combination therapy of rituximab with bendamustin in the patients with relapsed or resistnat low grade B-cell non-Hodgkin lymphoma
Scientific Title	Evaluation on efficacy and safety of a combination therapy of rituximab with bendamustin in the patients with relapsed or resistnat low grade B-cell non-Hodgkin lymphoma
Scientific Title:Acronym	Evaluation on efficacy and safety of a combination therapy of rituximab with bendamustin in the patients with relapsed or resistnat low grade B-cell non-Hodgkin lymphoma
Region	Japan

Condition
Condition	patients with relapsed or resistant low grade B-cell non-Hodgkin lymphoma
Classification by specialty	Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	There is little results on effcicacy and safety of the combination therapy of rituximab with bendamustin in the patients with relapsed or resistant low grade B-cell lymphoma in our country. Thus, these data obtained could contribute to the choice of chemotherapeutic modality in these patients.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Phase IV

Assessment
Primary outcomes	ORR
Key secondary outcomes	CR rate PFS adverse effect and data on laboratory findings

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	single
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	75 years-old >=
Gender	Male and Female
Key inclusion criteria	1)diagnosed as following Small lymphocytic lymphoma Lymphoplasmacytic lymphoma Splenic marginal zone B-cell lymphoma Extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue (MALT lymphoma) Nodal marginal zone B-cell lymphoma Mantle cell lymphoma 2) detaectable lesions (>1.5cm diameter) by CT scan 3) relapsed or resistant 4) >6 mo in estimated survival time 5) >20 yrs, <75 yrs 6) performance status 0-2 7) functional preservation of bone marrow, heart, lung, liver, and kidneys) 8) willingness to join this protocol
Key exclusion criteria	1) infected definitely 2) critical complication (liver failure or renal failure) 3) critical complication of heart disease 4) critical complication of bowel disease 5) positive for HBsAb, HCVAb, or HIVAb 6) critical hemostatic disease 7) involved in CNS 8) febrile >38C (except for tumor fever) 9) critical complication of respiratory disease 10) concomittent presence of another malignancy 11) AIHA 12) allergy of bendamustine 13) pregnant or breast-feeding 14) allergy of rituximab 15) uncontrol of contraception 16) not eligible for this study
Target sample size	26

Research contact person
Name of lead principal investigator	1st name Keichiro Middle name Last name Mihara
Organization	Hiroshima University Hospital
Division name	Department of Hematology and Oncology
Zip code	734-8553
Address	1-2-3 Kasumi, Minami-ku, Hiroshima, Japan
TEL	082-257-5555
Email	kmmihara@hiroshima-u.ac.jp

Public contact
Name of contact person	1st name Keichiro Middle name Last name Mihara
Organization	Hiroshima University Hospital
Division name	Department of Hematology and Oncology
Zip code	734-8553
Address	1-2-3 Kasumi, Minami-ku, Hiroshima, Japan
TEL	082-257-5861
Homepage URL
Email	kmmihara@hiroshima-u.ac.jp

Sponsor
Institute	Hiroshima University
Institute
Department

Funding Source
Organization	JSPS
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Hiroshima University
Address	1-2-3 Kasumi Minami-ku Hiroshima Japan
Tel	028-257-5555
Email	byo-keiei-tiken@office.hiroshima-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	広島大学病院（広島県）

Other administrative information
Date of disclosure of the study information	2012 Year 08 Month 07 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	2012 Year 06 Month 01 Day
Date of IRB	2012 Year 06 Month 01 Day
Anticipated trial start date	2012 Year 06 Month 01 Day
Last follow-up date	2015 Year 05 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 08 Month 07 Day
Last modified on	2021 Year 08 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009237