UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000007110
Receipt number R000008375
Scientific Title Analysis of Rituximab intensification therapy for low grade B-cell lymphoma refractory to Bendamustine
Date of disclosure of the study information 2012/01/27
Last modified on 2022/09/28 16:01:43

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Basic information

Public title

Analysis of Rituximab intensification therapy for low grade B-cell lymphoma refractory to Bendamustine

Acronym

Bendamustine intensification therapy for low grade B-cell lymphoma refractory to Bendamustine

Scientific Title

Analysis of Rituximab intensification therapy for low grade B-cell lymphoma refractory to Bendamustine

Scientific Title:Acronym

Bendamustine intensification therapy for low grade B-cell lymphoma refractory to Bendamustine

Region

Japan


Condition

Condition

low grade B-cell lymphoma

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To examine whether the response ratio of low grade B-cell lymphoma refractory to Bendamustine will be improved by Rituximab intensification therapy.

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

response ratio

Key secondary outcomes

progression free survival and safety


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Rituximab intensification in case of partial response or stable disease

Interventions/Control_2

observation in case of complete remission

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


Not applicable

Gender

Male and Female

Key inclusion criteria

Relapse and refractory low grade B-cell lymphoma patients who will be treated with Bendamustine. Their hepatic and renal functions should be normal.

Key exclusion criteria

1. for whom Bendamustine is contraindication
2. with liver cirrhosis
3. with severe mental disability
4. pregnant or possible to be pregnant

Target sample size

50


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Junji Tanaka

Organization

Tokyo women's medical university

Division name

department of hematology

Zip code


Address

8-1 Kawada-cho, Shinjuku-ku, Tokyo, Japan

TEL

03-3353-8111

Email

jutanaka@dh.twmu.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Yoichi Imai

Organization

Tokyo women's medical university

Division name

department of hematology

Zip code


Address

8-1 Kawada-cho, Shinjuku-ku, Tokyo, Japan

TEL

03-3353-8111

Homepage URL


Email

imaiyo@dh.twmu.ac.jp


Sponsor or person

Institute

Tokyo women's medical university

Institute

Department

Personal name



Funding Source

Organization

Tokyo women's medical university

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


Address


Tel


Email



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 01 Month 27 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

2011 Year 01 Month 24 Day

Date of IRB

2012 Year 01 Month 01 Day

Anticipated trial start date

2012 Year 01 Month 01 Day

Last follow-up date

2020 Year 01 Month 01 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 01 Month 20 Day

Last modified on

2022 Year 09 Month 28 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008375


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name