UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008024 |
|---|---|
| Receipt number | 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 15:15:54 |
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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
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
hemato@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University Hematology Study Group
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009438
