UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009243 |
|---|---|
| Receipt number | R000010844 |
| Scientific Title | A randomized phase2 study of bendamustine plus Rituximab for relapsing or refractory follicular lymphoma comparing 90 mg/sqm BR vs. 120 mg/sqm BR. |
| Date of disclosure of the study information | 2012/12/01 |
| Last modified on | 2020/03/25 11:41:52 |
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Basic information
Public title
A randomized phase2 study of bendamustine plus Rituximab for relapsing or refractory follicular lymphoma comparing 90 mg/sqm BR vs. 120 mg/sqm BR.
Acronym
JYCSG NHL01 study
Scientific Title
A randomized phase2 study of bendamustine plus Rituximab for relapsing or refractory follicular lymphoma comparing 90 mg/sqm BR vs. 120 mg/sqm BR.
Scientific Title:Acronym
JYCSG NHL01 study
Region
| Japan |
Condition
Condition
Follicular lymphoma
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This study is to select the best dosing of bendamustine (90 mg/sqm vs. 120 mg/sqm) plus Rituximab in patients with CD20 positive relapsing or refractory follicular lymphoma. Group 1 takes bendamustine 90 mg/sqm on day 1 and day 2, Rituximab 375 mg/sqm on day 1, repeat it for 6 cycles, 1cycle contains 28 days (standard regimen group). The other takes bendamustine 90 mg/sqm on day 1 and day 2, Rituximab 375 mg/sqm on day 1, repeat it for 6 cycles, 1cycle contains 28 days (high dose group).
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
CR
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Standerd dose bendamusutine 90mg/sqm day1-2
rituximab 375mg/sqm day1
1 cycle of 28days
Interventions/Control_2
Standerd dose bendamusutine 120mg/sqm day1-2
rituximab 375mg/sqm day1
1 cycle of 28days
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 Pathological diagnosis of follicular lymphoma on the basis of biopsy.
2 Patients who did not enter in partial remission (PR) by chemotherapy(except single adrenocortical hormones), or relapsed after attaining complete remission (CR) or PR.Regardless of the number and the type of ex-chemotherapy.
3 CD20 positive.
4 With measurable lesion (>1.5cm on the CT scan)
5 Age 20 to 80 at the time of registration.
6 ECOG Performance Status 0-2.
7 Patients who meet all the following standards.
Neutrophil count : More than 1,000/mm3
Hemoglobin :>= 8.0 g/dL
blood platelet count :>=75,000/mm3
AST, ALT, T-BIL in the blood: less than 2.5 times normal level
Electrocardiogram :normal or not required to be treated.
8 Expected at least 3 months survival.
9 Agree to participate in this study with written consent.
Key exclusion criteria
1 Pregnant women or nursing mothers. In postmenopausal women within a year. Women and men who cannot prevent pregnancy or do not have intension to prevent during the treatment period
2 With active double cancer (synchronous double cancer or metachronous double cancer which have 5-years of disease-free, except for basal cell carcinoma, squamous cell carcinoma, carcinoma in situ which goes into remission by topical treatment, or lesion part equivalent to intramucosal carcinoma.)
3 With mental disease or neurologic manifestation considered to be difficult to participate in this study.
4 HBV-DNA positive. HIV antibody-positive. HCV antibody-positive.
5 Patients have much tumor cell in peripheral blood (>=25,000/microL).
6 Having received hematopoietic stem cell transplantation.
7 With interstitial pneumonia, radiation pneumonia, or pulmonary fibrosis on the chest CT scan (within 3-months before registration).
8 With CNS infiltration.
9 Have experience with bendamustine treatment or diagnosed unsuitable for bendamustine treatment.
10 With severe drug hypersensitivity.
11 Judged as inappropriate for this study by the investigator.
Target sample size
36
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tomoiku Takaku |
Organization
Juntendo university
Division name
Department of hematology
Zip code
Address
3-1-1 Hongo, Bunkyo-ku, Tokyo
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Juntendo, Yamanashi Clinical Study Group
Division name
Department of hematology
Zip code
Address
TEL
Homepage URL
ttakaku@juntendo.ac.jp
Sponsor or person
Institute
Juntendo, Yamanashi Clinical Study Group
Institute
Department
Personal name
Funding Source
Organization
Hematopoietic stem cell disease study group
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
| 2012 | Year | 12 | Month | 01 | 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 | 09 | Month | 24 | Day |
Date of IRB
| 2013 | Year | 01 | Month | 01 | Day |
Anticipated trial start date
| 2013 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 31 | 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 | 11 | Month | 01 | Day |
Last modified on
| 2020 | Year | 03 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010844
