UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000008024
Receipt No. R000009438
Scientific Title 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
Date of disclosure of the study information 2012/06/04
Last modified on 2016/11/26

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title 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
Acronym Bendamustine and rituximab salvage trial for relapsed or refractory CD20 positive indolent B-cell non-Hodgkin lymphoma and mantle cell lymphoma patients
Scientific Title 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
Scientific Title:Acronym 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
1st name
Middle name
Last name Akifumi Takaori-Kondo
Organization Kyoto University Hospital
Division name Department of Hematology/Oncology
Zip code
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
1st name
Middle name
Last name Toshiyuki Kitano
Organization Kyoto University Hospital
Division name Department of Hematology/Oncology
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

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 No longer recruiting
Date of protocol fixation
2012 Year 05 Month 22 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000009438

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.