UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008145 |
|---|---|
| Receipt number | R000008601 |
| Scientific Title | Phase 2 study evaluating the efficacy and safety of the combination of Bendamustine, Rituximab and Dexamethazone (RBenda-D) for treatment of CD20-positive relapsed or refractory indolent B-cell non-Hodgkin lymphoma and mantle cell lymphoma. |
| Date of disclosure of the study information | 2012/06/12 |
| Last modified on | 2019/10/20 12:16:46 |
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Basic information
Public title
Phase 2 study evaluating the efficacy and safety of the combination of Bendamustine, Rituximab and Dexamethazone (RBenda-D) for treatment of CD20-positive relapsed or refractory indolent B-cell non-Hodgkin lymphoma and mantle cell lymphoma.
Acronym
Phase 2 study of Bendamustine, Rituximab and Dexamethazone(RBenda-D) for treatment of CD20-positive relapsed or refractory indolent B-cell non-Hodgkin lymphoma and mantle cell lymphoma.
Scientific Title
Phase 2 study evaluating the efficacy and safety of the combination of Bendamustine, Rituximab and Dexamethazone (RBenda-D) for treatment of CD20-positive relapsed or refractory indolent B-cell non-Hodgkin lymphoma and mantle cell lymphoma.
Scientific Title:Acronym
Phase 2 study of Bendamustine, Rituximab and Dexamethazone(RBenda-D) for treatment of CD20-positive relapsed or refractory indolent B-cell non-Hodgkin lymphoma and mantle cell lymphoma.
Region
| Japan |
Condition
Condition
Relapsed or refractory 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 evaluate the efficacy and safety of bendamustine, rituximab and dexamethazone(RBenda-D) CD20-positive relapsed or refractory indolent B-cell non-Hodgkin lymphoma and mantle cell 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 response rate
Event-free survival
Progression-free survival
Safty
Cycles completion rate for 3 or 6 cycles
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 + Rituximab + Dexamethazone
Rituximab Day 1 375mg/m2/day
Bendamustine Day 2, Day 3 90mg/m2/day
Dxamethazone Day 1,Day 2 20mg/m2/day div(or po)
Dxamethazone Day 3,Day 4 ,Day5 10mg/m2/day po(or div)
every 28days
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. Patients with pathologically confirmed indolent B-cell non-Hodgkin lymphoma or mantle cell lymphoma.
2. Patients had received prior treatment of rituximab in combination with chemotherapy (without corticosteroid alone) or antibody treatments that rituximab alone or ibritumomab tiuxetan, and were considered no response or relapse after CR or PR.
3. CD20 positive
4. Patients have measurable lesion that measured >=1.5cm in a single dimension by CT.
5. Patients aged 20-80 years.
6. PS(ECOG) 0-2
7. Patients meet all following standard
Absolute neutrophil count >= 1,500/mm3
Platelet count >= 80,000/mm3
AST and ALT < 2.5 times facility criteria.
Total bilirubin = <2.0mg/dl
Creatinine = <2.0mg/dl
Cardiac electro gram : nomal or no abnormality required treatment
SpO2 : >= 90%
8. Patients have a life expectancy > 3 months.
9. Written informed consent.
Key exclusion criteria
1. Patients are pregnant or lactating women.
Patients (<1 year after menopause without surgical infertility) can not or will not use birth control during the treatment.
2. Patients have active other malignant diseases including simultaneous cancer and disease free state within 5 years after treatment for other cancer except curable intramural cancer by local treatment.
3. Patients have mental disease or disorder with difficulty in participating in the clinical trial.
4. HBs antigen positive
5. HCV antibody positive
6. HIV antibody positive
7. Patients have much tumor cell in peripheral blood (>=25,000/microL).
8. Patients received allogeneic hematopoietic [hemopoietic] stem cell transplant.
9. Patients have interstitial lung disease or fibroid lung.
10. Patients have CNS invasion.
11. Patients already received bendamustine treatment.
12. Patients are inappropriate for rituximab treatment.
13. Patients have severe allergic symptoms.
14. Inadequate for clinical trial entry by the attending physicians.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Masafumi |
| Middle name | |
| Last name | Taniwaki |
Organization
Kyoto Prefectural University of Medicine
Division name
Division of Hematilogy and Oncology
Zip code
602-8566
Address
Kawaramachi Hirokoji Kamigyo-ku,Kyoto 602-8566,JAPAN
TEL
075-251-5740
taniwaki@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | Yosuke |
| Middle name | |
| Last name | Matsumoto |
Organization
Kyoto Prefectural University of Medicine
Division name
Division of Hematilogy and Oncology
Zip code
602-8566
Address
Kawaramachi Hirokoji Kamigyo-ku,Kyoto,JAPAN
TEL
075-251-5740
Homepage URL
yosuke-m@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto Prefectural University of Medicine/K-LSG
Institute
Department
Personal name
Funding Source
Organization
Kyoto Prefectural University of Medicine
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
Kyoto Prefectural University of Medicine
Address
Kawaramachi Hirokoji Kamigyo-ku,Kyoto 602-8566,JAPAN
Tel
075-251-5111
yosuke-m@koto.kpu-m.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
京都府立医科大学（京都府）、社団法人愛生会山科病院（京都府）、大津市民病院（滋賀県）、京都第一赤十字病院（京都府）、京都第二赤十字病院（京都府）、社会保険京都病院（京都府）、松下記念病院（大阪府）、近江八幡市立総合医療センター（滋賀県）、市立福知山市民病院（京都府）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 06 | Month | 12 | Day |
Related information
URL releasing protocol
https://link.springer.com/article/10.1007%2Fs12185-019-02650-w
Publication of results
Published
Result
URL related to results and publications
https://link.springer.com/article/10.1007%2Fs12185-019-02650-w
Number of participants that the trial has enrolled
33
Results
The ORR was 88% with 58% attaining CR/CRu. A median follow-up time for all patients was 37 months. The 3-year PFS and OS rates were 75.5 +/- 8.1% (standard error) and 85.5 +/- 6.8%, respectively.
The leading adverse event was myelosuppression. Incidence of grade 3-4 leukocytope
nia, neutropenia, and lymphocytopenia was 55%, 67%, and 91%, respectively. The most frequent nonhematological adverse events were CMV antigenemia and rash (33% and 30%, respectively).
Results date posted
| 2019 | Year | 06 | Month | 18 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2019 | Year | 05 | Month | 24 | Day |
Baseline Characteristics
Thirty-three patients were enrolled between July 2011 and December 2014. Median age was 63 years old (range 50-78 years). Histological subtypes were as follows: follicular lymphoma, 26 patients; MALT lymphoma, 3 patients; lymphoplasmacytic lymphoma, 1 patient; mantle cell lymphoma, 3 patients.
Participant flow
While 37 patients applied to this study between July 2011 and December 2014, we enrolled 33 patients. Four patients were ineligible for inclusion, because 2 had been treated with bendamustine previously, one was diagnosed as FL grade 3b, and the other was > 80 years.
Adverse events
The leading adverse event was myelosuppression. Incidence of grade 3-4 leukocytope
nia, neutropenia, and lymphocytopenia was 55%, 67%, and 91%, respectively. The most frequent nonhematological adverse events were CMV antigenemia and rash (33% and 30%, respectively).
Outcome measures
While the primary endpoint was the ORR in all eligible patients, secondary endpoints were
the CRR, PFS, safety, and the completion rates of the first three cycles and all six cycles of chemotherapy.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2011 | Year | 06 | Month | 15 | Day |
Date of IRB
| 2011 | Year | 07 | Month | 21 | Day |
Anticipated trial start date
| 2011 | Year | 07 | Month | 21 | Day |
Last follow-up date
| 2016 | Year | 06 | Month | 28 | Day |
Date of closure to data entry
| 2016 | Year | 07 | Month | 31 | Day |
Date trial data considered complete
| 2016 | Year | 09 | Month | 16 | Day |
Date analysis concluded
| 2018 | Year | 11 | Month | 27 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 06 | Month | 12 | Day |
Last modified on
| 2019 | Year | 10 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008601
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