UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008702 |
|---|---|
| Receipt number | R000010178 |
| Scientific Title | A randomized phase2 study of bendamustine monotherapy for relapsing or refractory low-grade B-cell non-Hodgkin's lymphoma or mantle cell lymphoma comparing administration schedule. |
| Date of disclosure of the study information | 2012/08/23 |
| Last modified on | 2015/02/16 11:51:15 |
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Basic information
Public title
A randomized phase2 study of bendamustine monotherapy for relapsing or refractory low-grade B-cell non-Hodgkin's lymphoma or mantle cell lymphoma comparing administration schedule.
Acronym
RABBIT-14
Scientific Title
A randomized phase2 study of bendamustine monotherapy for relapsing or refractory low-grade B-cell non-Hodgkin's lymphoma or mantle cell lymphoma comparing administration schedule.
Scientific Title:Acronym
RABBIT-14
Region
| Japan |
Condition
Condition
Low-grade B-cell non-Hodgkin's lymphoma or mantle cell 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 administration schedule of bendamustine monotherapy in patients with low-grade CD20 positive B-cell non-Hodgkin's lymphoma or mantle cell lymphoma. Group 1 takes bendamustine on day 1 and day 2, repeat it for 6 cycles, 1cycle contains 21 days (standard regimen group). The other takes bendamustine on day 1 and day15, repeat it for 6 cycles, 1cycle consist of 28 days (Benda-14 group)
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Completion rate of 6 cycles
Key secondary outcomes
Overall response rate;ORR
Complete response rate;CR
Event-free survival;EFS
Progression-free survival;PFS
Safety(frequency and severity of adverse events and adverse drug reactions)
Immune-function monitoring(CD4 lymphocyte count, CD4 / 8 ratios )
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Standard regimen group
bendamustine Day1, 2 120mg/m2/ day 1 cycle consists of 21 days
Interventions/Control_2
Benda-14 regimen group
bendamustine Day1, 15 120mg/m2/ day 1 cycle consists of 28 days
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 low-grade B-cell non-Hodgkin's lymphoma or a mantle cell 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.Being able to have 4 weeks washout period of anticancer drug.(two weeks washout for Rituxan and Zevalin)
4.CD20 positive.
5.lWith measurable lesion (>1.5cm on the CT scan)
6.Age 20 to 80 at the time of registration.
7.ECOG Performance Status 0-2.
8.Patients who meet all the following standards within 14 days before registration.
a.Neutrophil count : More than 1,000/mm3
b.Hemoglobin :>= 8.0 g/dL
c.blood platelet count :>=100,000/mm3
d.AST, ALT in the blood: less than 2.5 times normal level
e.T-BIL in the blood <=2.0 mg/dl
f.Serum creatinine : <=2.0 mg/dl
g.Electrocardiogram :normal or not required to be treated.
h.SpO2:>=95%
9.Expected at least 3 months survival.
10.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.HBs antigen positive.
5.HIV antibody-positive.
6.With a lot of tumor cells in peripheral blood (more than 25,000/µL).
7.having received hematopoietic stem cell transplantation.
8.With interstitial pneumonia, radiation pneumonia, or pulmonary fibrosis on the chest CT scan (within 3-months before registration).
9.With CNS infiltration.
10.Have experience with bendamustine treatment or diagnosed unsuitable for bendamustine treatment.
11.With severe drug hypersensitivity.
12.Judged as inappropriate for this study by the investigator.
Target sample size
54
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kuniaki Itoh |
Organization
National Cancer Center Hospital East
Division name
Division of Hematology/Oncology
Zip code
Address
6-5-1,Kashiwanoha,Kashiwa-shi,Chiba-ken
TEL
04-7133-1111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hisashi Wakita |
Organization
Japanese Red Cross Society Narita Hospital
Division name
Department of Hematology and Oncology
Zip code
Address
90-1, Iida-cho, Narita-shi, Chiba-ken
TEL
0476-22-2311
Homepage URL
Sponsor or person
Institute
Shimousa blood study group
Institute
Department
Personal name
Funding Source
Organization
NPO Advanced Clinical Research Organization
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
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
君津中央病院
群馬県立がんセンター
国保大綱病院
国保松戸市立病院
国立がん研究センター東病院
千葉県立がんセンター
千葉大学医学部附属病院
東京慈恵会医科大学附属柏病院
成田赤十字病院
日本医科大学千葉北総合病院
日本赤十字社医療センター
横浜労災病院
千葉労災病院
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 08 | Month | 23 | 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
No longer recruiting
Date of protocol fixation
| 2012 | Year | 08 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 09 | Month | 03 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 08 | Month | 16 | Day |
Last modified on
| 2015 | Year | 02 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010178
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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