UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013795 |
|---|---|
| Receipt number | R000016103 |
| Scientific Title | Phase II study of Bendamustine-Rituximab therapy for CD20-positive untreated and advanced follicular lymphoma with poor response to R-CHOP therapy |
| Date of disclosure of the study information | 2014/04/24 |
| Last modified on | 2021/10/28 09:27:46 |
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Basic information
Public title
Phase II study of Bendamustine-Rituximab therapy for CD20-positive untreated and advanced follicular lymphoma with poor response to R-CHOP therapy
Acronym
Bendamustine Convert Study
Scientific Title
Phase II study of Bendamustine-Rituximab therapy for CD20-positive untreated and advanced follicular lymphoma with poor response to R-CHOP therapy
Scientific Title:Acronym
Bendamustine Convert Study
Region
| Japan |
Condition
Condition
untreated and advanced follicular lymphoma
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate for safety and efficacy of bendamustine and rituximab, B-R combination therapy up to 6 cycles for the patients of CD20-positive untreated and advanced follicular lymphoma with poor response to R-CHOP therapy
Basic objectives2
Others
Basic objectives -Others
Exploratory endpoints were to investigate clinical prognostic factors in this trial.
As a validation cohort, we reviewed and collected the medical records of 100 pts with treatment-naive FL or relapsed FL after R-CHOP who were treated with R-B from 2010 to 2020
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Progression free survival rate of 3 years of BR therapy enforcement group
Key secondary outcomes
1) Response rate
2) Complete response rate
3)Progression free survival (the median)
4) Safety (Adverse events)
5) Convalescence prediction factor of follicular lymphoma
6) Overall survival
7) histological transformation
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
The R-CHOP treatment 1 2 cycles
2 cycles of R-CHOP treatments are enforced as three-week one cycle.
RituximubDay1375mg/m2/DayDiv
Cyclophosphamids750mg/m2/dayDiv
Doxorvicin50mg/m2/dayIv
Vincristin1.4mg/m2/dayIv(Max.2.0mg/body)po/i
Predonisolon100mg/body/dayv
Filgrastim75ug/bodySc
CT is enforced among day+15-21 of the 2nd cycles.
An effect judging is judged based on the visual assessment of CT.poor response group (BR treatment group)B-Rcombination therapy up to 6 cycles.
RituximabDay1 375mg/m2/dayDiv BendamustineDay2Day390mg/m2Div
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
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)Advance term (Ann Arbor stage III/IV) follicular lymphoma or stage II with a bulky disease of 7 cm or more
(or 1.B cell non-Hodgkin's lymphoma, 2.Intermediate-high risk of FLIPI2 index 3.Treatment is required )
2) Histologically confirmed CD20 positive B cell non-Hodgkin's lymphoma (follicular lymphoma: Grade 1-3a)
3) Mesureable disease (Major-axis:> 1.5 cm by CT)
4)age20-85
5)Performance Status (ECOG)0-2
6)Adequate organ function
7)No severe complications
8)Expected at least 3 months survival
9)Written informed consent obtained
Key exclusion criteria
1)Any other active malignancies
2)Uncontrollable serious complications
(diabetes, heart failure, cardiomyopathy, abnormal heart rhythm, angina, myocardial infarction, interstitial pneumonia, pulmonary fibrosis, radiation pneumonia, infection, a respiratory failure, an organic lung disease, hepatic insufficiency, liver cirrhosis, acute chronic hepatitis, renal insufficiency, etc.) patients with active tuberculosis
3)Circulating lymphoma cells >= 25,000 /uL in peripheral blood
4)Primary central nervous system lymphoma or central nervous system invasion
5)Anaphylactic shock for any drugs
6)The HCV antibody-positive
7)Inappropriate for rituximab treatment
8)Serious mental disorder, such as schizophrenia
9)Diagnosed as a malignant lymphoma, leukemia, and myelodysplastic syndromes in the past
10)The treatment history of the chemotherapy, the radiotherapy, cytokine therapy, and antibody therapy to FL
11)Pregnant/female patients who are unwilling to take prevention measures for contraception during treatment
12)HIV antibody-positive
13)Inappropriate for entry by physician's decision
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Yoichi |
| Middle name | |
| Last name | Tatsumi |
Organization
Kinki University Faculty of Medicine
Division name
Department of Hematology and Rheumatology,
Zip code
589-8511
Address
OSAKA SAYAMA CITY OONOHIGASHI377-2
TEL
0723660221
rai@med.kindai.ac.jp
Public contact
Name of contact person
| 1st name | youichi |
| Middle name | |
| Last name | tatsumi |
Organization
Kinki University Faculty of Medicine
Division name
Department of Hematology and Rheumatology,
Zip code
5898511
Address
OSAKA SAYAMA CITY OONOHIGASHI377-2
TEL
072-366-0221
Homepage URL
inter-3@med.kindai.ac.jp
Sponsor or person
Institute
Department of Hematology and Rheumatology,Kinki University Faculty of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Hematology and Rheumatology,Kinki University Faculty of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
HyogoCRB
Address
Nishinomiya city mukogawa cho 1-1
Tel
0798456111
rinken@hyo-med.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
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 04 | Month | 24 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
60
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2021 | Year | 08 | Month | 17 | Day |
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2013 | Year | 03 | Month | 08 | Day |
Date of IRB
| 2013 | Year | 03 | Month | 08 | Day |
Anticipated trial start date
| 2013 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2022 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2022 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 04 | Month | 23 | Day |
Last modified on
| 2021 | Year | 10 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016103
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