UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005386 |
|---|---|
| Receipt number | R000006388 |
| Scientific Title | Phase II trial of bendamustine plus rituximab treatment for relapsed or refractory low grade B-cell non Hodgkin lymphoma |
| Date of disclosure of the study information | 2011/04/07 |
| Last modified on | 2013/04/06 09:14:14 |
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Basic information
Public title
Phase II trial of bendamustine plus rituximab treatment for relapsed or refractory low grade B-cell non Hodgkin lymphoma
Acronym
Phase II trial of BR treatment for relapsed or refractory low grade B-NHL
Scientific Title
Phase II trial of bendamustine plus rituximab treatment for relapsed or refractory low grade B-cell non Hodgkin lymphoma
Scientific Title:Acronym
Phase II trial of BR treatment for relapsed or refractory low grade B-NHL
Region
| Japan |
Condition
Condition
relapsed or refractory follicular lymphoma
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate efficacy and safety of bendamustine plus rituximab treatment for relapsed or refractory follicular lymphoma
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
overall response rate
Key secondary outcomes
complete remission rate, event free survival, progression free survival, toxicity
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
bendamustine plus rituximab treatment
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: diagnosed as follicular lymphoma histologically
2: relapse or progression after rituximab containing treatment or anti-body treatment
3: CD20 positive
4: measurable lesion (long axis on CT scan > 1.5cm)
5: age 20-79 years
6: ECOG performance status 0-2
7: adequate organ function as follows;
1)absolute neutrophil count > 1.5 x 10*9/L
2)hemoglobin > 8.0mg/dl
3)platelet count > 100 x 10*9/L
4)AST and ALT levels < 2.5 times the upper limit of the normal range
5)total bilirubin level < 2.0 mg/dL
6)serum creatinine level < 2.0 mg/dL
7)normal ECG
8)SpO2 > 95%
8: life expectancy more than 3 months
9: written informed consent
Key exclusion criteria
1: pregnancy or breast feeding
2: any other malignancy
3: mental illness
4: positive test for HBV surface antigen
5: positive test for HCV anti body
6: positive test for HIV anti body
7: lymphoma cell count > 25 x 10*9/L in peripheral blood
8: post allogenic stem cell transplantation
9: interstitial pneumonia or pulmonary fibrosis
10: central nervous system involvement with lymphoma
11: history of bendamustine treatment
12: inappropriate for rituximab treatment
13: severe hypersensitivity for any drugs
14: inappropriate for entry by physician's decision
Target sample size
44
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kiyoshi Ando |
Organization
Tokai University
Division name
Division of hematology/oncology, department of internal medicine,
Zip code
Address
Shimokasuya 143, Isehara, Kanagawa, Japan
TEL
0463-93-1121
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ken Ohmachi |
Organization
Tokai University
Division name
Division of hematology/oncology, department of internal medicine
Zip code
Address
Shimokasuya 143, Isehara, Kanagawa, Japan
TEL
0463-93-1121
Homepage URL
8jmmd004@is.icc.u-tokai.ac.jp
Sponsor or person
Institute
Kanagawa Clinical Oncology study Group
Institute
Department
Personal name
Funding Source
Organization
not applicable
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
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
東海大学医学部付属病院（神奈川県）
聖マリアンナ医科大学（神奈川県）
神奈川県立がんセンター（神奈川県）
北里大学（神奈川県）
藤沢市民病院（神奈川県）
横浜市立大学附属市民総合医療センター（神奈川県）
横浜市立大学（神奈川県）
湘南鎌倉病院（神奈川県）
横浜市立市民病院（神奈川県）
横浜労災病院（神奈川県）
関東労災病院（神奈川県）
昭和大学藤が丘病院（神奈川県）
海老名総合病院（神奈川県）
横浜市立みなと赤十字病院（神奈川県）
秦野赤十字病院（神奈川県）
小澤病院（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 04 | 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
| 2010 | Year | 11 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 04 | Month | 06 | Day |
Last modified on
| 2013 | Year | 04 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006388
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