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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005386
Receipt No. 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

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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
Email

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
Email 8jmmd004@is.icc.u-tokai.ac.jp

Sponsor
Institute Kanagawa Clinical Oncology study Group
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006388

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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