UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000008145
Receipt No. 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 (Ver. 12)

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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
Email 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
Email yosuke-m@koto.kpu-m.ac.jp

Sponsor
Institute Kyoto Prefectural University of Medicine/K-LSG
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000008601