UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010923 |
|---|---|
| Receipt number | R000012783 |
| Scientific Title | A clinical phase II study assessing the safety and efficacy of readministration of bendamustine monotherapy or bendamustine/rituximab for relapsed low grade B cell non-Hodgkin lymphoma or mantle cell lymphoma patients previously treated with bendamustine containing chemothearpy |
| Date of disclosure of the study information | 2013/06/17 |
| Last modified on | 2020/12/15 12:38:23 |
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Basic information
Public title
A clinical phase II study assessing the safety and efficacy of readministration of bendamustine monotherapy or bendamustine/rituximab for relapsed low grade B cell non-Hodgkin lymphoma or mantle cell lymphoma patients previously treated with bendamustine containing chemothearpy
Acronym
Assessment of the safety and efficacy of bendamustine retreatment
Scientific Title
A clinical phase II study assessing the safety and efficacy of readministration of bendamustine monotherapy or bendamustine/rituximab for relapsed low grade B cell non-Hodgkin lymphoma or mantle cell lymphoma patients previously treated with bendamustine containing chemothearpy
Scientific Title:Acronym
Assessment of the safety and efficacy of bendamustine retreatment
Region
| Japan |
Condition
Condition
low-grade B cell non-Hodgkin lymphoma, Mantle cell lymphoma
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Overall response rate after 2 cycles of therapy
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Overall response rate after 2 cycles of thearpy
Key secondary outcomes
1. Best overall response rate
2. complete response rate
3. progression free survival
4. safety
5. safety and efficacy after each cycle of treatment
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 monotherapy or bendamustine/rituximab therapy will be administered
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients who have been diagnosed as histologically confirmed low-grade B cell non-Hodgkin's lymphoma or mantle cell lymphoma
2. Patients who have received bendamustine containing chemothrapy
3. Patients who have maintained reponse(greater than PR) to previous bendamustine containing regimen for over 3 months
4. Patients with measurable disease
5. Patients over 20 years-old
6. ECOG PS of 0 - 2
7. Patients who fulfill the following criteria
ANC > 1,000 /mm3
Hgb > 8.0g /dL
Plt > 75,000 /mm3
AST, ALT < x2.5 ULN
T-Bil <2.0 mg/dl
Cr <2.0 mg/dl
8. Patients with a life expectancy of > 3 months
9. Patients who can give written informed consent to the study
Key exclusion criteria
1. patients who are pregnant/female patients who are unwilling to take prevention measures for contraception during treatment
2. patients with active cancer
3. patients wih mental illnesses that the treating physician judges difficult to participate in the study
4. patients with circulating tumor cells > 25,000 /uL
5. patients with severe allergic reaction to medication
6. patients with active infectious diseases
7. patients who are positive for HBs antigen or HBV-DNA
8. patients who are judged inadequate to participate in the study according to the treating physician
Target sample size
38
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takayuki Shimizu |
Organization
Keio University School of Medicine
Division name
Division of Hematology
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
+81-3-3353-1211
taka-sh@keio.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Koichi Murakami |
Organization
Keio University School of Medicine
Division name
Division of Hematology
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL
+81-3-3353-1211
Homepage URL
k.murakami1020@a8.keio.jp
Sponsor or person
Institute
KEIO BRB Study Group
Institute
Department
Personal name
Funding Source
Organization
N/A
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
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 06 | Month | 17 | 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
| 2013 | Year | 06 | Month | 03 | Day |
Date of IRB
| 2013 | Year | 03 | Month | 23 | Day |
Anticipated trial start date
| 2013 | Year | 06 | Month | 17 | Day |
Last follow-up date
| 2020 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
| 2020 | Year | 08 | Month | 06 | Day |
Date trial data considered complete
| 2020 | Year | 08 | Month | 06 | Day |
Date analysis concluded
| 2020 | Year | 08 | Month | 06 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 06 | Month | 10 | Day |
Last modified on
| 2020 | Year | 12 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012783
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