UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase II clinical trial of combination chemotherapy with bendamustine and rituximab for relapsed or refractory CD20 positive indolent B-cell non-Hodgkin lymphoma and mantle cell lymphoma patients
Title of the study (Brief title)	Bendamustine and rituximab salvage trial for relapsed or refractory CD20 positive indolent B-cell non-Hodgkin lymphoma and mantle cell lymphoma patients
Region	Japan

Condition
Condition	CD20 positive indolent B-cell non-Hodgkin lymphoma and mantle cell lymphoma
Classification by specialty	Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To test the safety and efficacy of combination chemotherapy with bendamustine and rituximab in relapsed or refractory CD20 positive indolent B-cell non-Hodgkin lymphoma and mantle cell lymphoma patients.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	Progression free survival
Key secondary outcomes	1, response rate 2, complete response rate 3, overall survival 4, event-free survival 5, proportion of patients completing 3 and 6 cycles of treatment 6, incidence of grade 3 and 4 adverse events 7, assessment of immunological parameters during and after treatment

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Rituximab 375mg/m2 on day 1, and bendamustine 90mg/m2 on day 1 and 2, or day 2 and 3. Repeated every 28 days for 6 cycles.
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, pathological diagnosis of indolent B-cell non-Hodgkin lymphoma or mantle cell lymphoma 2, relapsed or progressed after achieving response to prior chemotherapy, or resistant to prior chemotherapy. 3, CD20 positive disease 4, with assessable lesions 5, ECOG Performance Status of 0 to 2
Key exclusion criteria	1, pregnant or breast-feeding women 2, patients with active second cancer 3, HBs antigen positive or HBV-DNA positive patients 4, HIV antibody positive patients 5, patients who have been treated with stem cell transplantation 6, interstitial pneumonitis or pulmonary fibrosis 7, patients with central nervous system involvement 8, patients who have already received bendamustine treatment
Target sample size	45

Research contact person
Name of lead principal investigator	Akifumi Takaori-Kondo
Organization	Kyoto University Hospital
Division name	Department of Hematology/Oncology
Address	54 Shogoin-Kawaharacho, Sakyo, Kyoto, 606-8507, JAPAN
TEL	075-751-4964
Email	hemato@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person	Toshiyuki Kitano
Organization	Kyoto University Hospital
Division name	Department of Hematology/Oncology
Address	54 Shogoin-Kawaharacho, Sakyo, Kyoto, 606-8507, JAPAN
TEL	075-751-4964
Homepage URL
Email	hemato@kuhp.kyoto-u.ac.jp

Sponsor
Institute	Kyoto University Hematology Study Group
Institute
Department

Funding Source
Organization	Foundation for Biomedical Research and Innovation
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization	Japan

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	京都大学医学部附属病院(京都府)、静岡市立静岡病院(静岡県）、静岡県立総合病院(静岡県）、市立島田市民病院(静岡県）、市立長浜病院(滋賀県)、滋賀県立成人病センター(滋賀県)、大津赤十字病院(滋賀県)、京都市立病院(京都府)、洛和会音羽病院(京都府)、医仁会武田総合病院(京都府)、日本バプテスト病院(京都府)、京都桂病院(京都府)、天理よろづ相談所病院(奈良県)、高の原中央病院(奈良県)、日赤和歌山医療センター(和歌山県)、高槻赤十字病院(大阪府)、大阪赤十字病院(大阪府)、関西電力病院(大阪府)、北野病院(大阪府)、住友病院(大阪府)、県立塚口病院(兵庫県)、県立尼崎病院(兵庫県)、神戸市立医療センター中央市民病院(兵庫県)、神鋼病院(兵庫県)、姫路医療センター(兵庫県)、倉敷中央病院(岡山県)、高松赤十字病院(香川県)、小倉記念病院(福岡県)

Other administrative information
Date of disclosure of the study information	2012 Year 06 Month 04 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2012 Year 05 Month 22 Day
Anticipated trial start date	2012 Year 06 Month 25 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2012 Year 05 Month 24 Day
Last modified on	2016 Year 11 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000009438