UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008638 |
|---|---|
| Receipt number | R000009237 |
| Scientific Title | Evaluation on efficacy and safety of a combination therapy of rituximab with bendamustin in the patients with relapsed or resistnat low grade B-cell non-Hodgkin lymphoma |
| Date of disclosure of the study information | 2012/08/07 |
| Last modified on | 2021/08/25 16:52:24 |
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Basic information
Public title
Evaluation on efficacy and safety of a combination therapy of rituximab with bendamustin in the patients with relapsed or resistnat low grade B-cell non-Hodgkin lymphoma
Acronym
Evaluation on efficacy and safety of a combination therapy of rituximab with bendamustin in the patients with relapsed or resistnat low grade B-cell non-Hodgkin lymphoma
Scientific Title
Evaluation on efficacy and safety of a combination therapy of rituximab with bendamustin in the patients with relapsed or resistnat low grade B-cell non-Hodgkin lymphoma
Scientific Title:Acronym
Evaluation on efficacy and safety of a combination therapy of rituximab with bendamustin in the patients with relapsed or resistnat low grade B-cell non-Hodgkin lymphoma
Region
| Japan |
Condition
Condition
patients with relapsed or resistant low grade B-cell non-Hodgkin lymphoma
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
There is little results on effcicacy and safety of the combination therapy of rituximab with bendamustin in the patients with relapsed or resistant low grade B-cell lymphoma in our country. Thus, these data obtained could contribute to the choice of chemotherapeutic modality in these patients.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase IV
Assessment
Primary outcomes
ORR
Key secondary outcomes
CR rate
PFS
adverse effect and data on laboratory findings
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
single
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)diagnosed as following
Small lymphocytic lymphoma
Lymphoplasmacytic lymphoma
Splenic marginal zone B-cell lymphoma
Extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue (MALT lymphoma)
Nodal marginal zone B-cell lymphoma
Mantle cell lymphoma
2) detaectable lesions (>1.5cm diameter) by CT scan
3) relapsed or resistant
4) >6 mo in estimated survival time
5) >20 yrs, <75 yrs
6) performance status 0-2
7) functional preservation of bone marrow, heart, lung, liver, and kidneys)
8) willingness to join this protocol
Key exclusion criteria
1) infected definitely
2) critical complication (liver failure or renal failure)
3) critical complication of heart disease
4) critical complication of bowel disease
5) positive for HBsAb, HCVAb, or HIVAb
6) critical hemostatic disease
7) involved in CNS
8) febrile >38C (except for tumor fever)
9) critical complication of respiratory disease
10) concomittent presence of another malignancy
11) AIHA
12) allergy of bendamustine
13) pregnant or breast-feeding
14) allergy of rituximab
15) uncontrol of contraception
16) not eligible for this study
Target sample size
26
Research contact person
Name of lead principal investigator
| 1st name | Keichiro |
| Middle name | |
| Last name | Mihara |
Organization
Hiroshima University Hospital
Division name
Department of Hematology and Oncology
Zip code
734-8553
Address
1-2-3 Kasumi, Minami-ku, Hiroshima, Japan
TEL
082-257-5555
kmmihara@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Keichiro |
| Middle name | |
| Last name | Mihara |
Organization
Hiroshima University Hospital
Division name
Department of Hematology and Oncology
Zip code
734-8553
Address
1-2-3 Kasumi, Minami-ku, Hiroshima, Japan
TEL
082-257-5861
Homepage URL
kmmihara@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University
Institute
Department
Personal name
Funding Source
Organization
JSPS
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hiroshima University
Address
1-2-3 Kasumi Minami-ku Hiroshima Japan
Tel
028-257-5555
byo-keiei-tiken@office.hiroshima-u.ac.jp
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
広島大学病院（広島県）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 08 | 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
| 2012 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2012 | Year | 06 | Month | 01 | Day |
Anticipated trial start date
| 2012 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 05 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 08 | Month | 07 | Day |
Last modified on
| 2021 | Year | 08 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009237
