UMIN-CTR Clinical Trial

Public title

Phase II clinical trial of combination chemotherapy with bendamustine and rituximab for relapsed or refractory CD20 positive indolent B-cell non-Hodgkin lymphoma and mantle cell lymphoma patients

Acronym

Bendamustine and rituximab salvage trial for relapsed or refractory CD20 positive indolent B-cell non-Hodgkin lymphoma and mantle cell lymphoma patients

Scientific Title

Phase II clinical trial of combination chemotherapy with bendamustine and rituximab for relapsed or refractory CD20 positive indolent B-cell non-Hodgkin lymphoma and mantle cell lymphoma patients

Scientific Title:Acronym

Bendamustine and rituximab salvage trial for relapsed or refractory CD20 positive indolent B-cell non-Hodgkin lymphoma and mantle cell lymphoma patients

Region

Japan

Condition

CD20 positive indolent B-cell non-Hodgkin lymphoma and mantle cell lymphoma

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To test the safety and efficacy of combination chemotherapy with bendamustine and rituximab in relapsed or refractory CD20 positive indolent B-cell non-Hodgkin lymphoma and mantle cell lymphoma patients.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Developmental phase

Phase II

Primary outcomes

Progression free survival

Key secondary outcomes

1, response rate
2, complete response rate
3, overall survival
4, event-free survival
5, proportion of patients completing 3 and 6 cycles of treatment
6, incidence of grade 3 and 4 adverse events
7, assessment of immunological parameters during and after treatment

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Historical

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Rituximab 375mg/m2 on day 1, and bendamustine 90mg/m2 on day 1 and 2, or day 2 and 3. Repeated every 28 days for 6 cycles.

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

Age-lower limit

20

years-old

<=

Age-upper limit

80

years-old

>

Gender

Male and Female

Key inclusion criteria

1, pathological diagnosis of indolent B-cell non-Hodgkin lymphoma or mantle cell lymphoma
2, relapsed or progressed after achieving response to prior chemotherapy, or resistant to prior chemotherapy.
3, CD20 positive disease
4, with assessable lesions
5, ECOG Performance Status of 0 to 2

Key exclusion criteria

1, pregnant or breast-feeding women
2, patients with active second cancer
3, HBs antigen positive or HBV-DNA positive patients
4, HIV antibody positive patients
5, patients who have been treated with stem cell transplantation
6, interstitial pneumonitis or pulmonary fibrosis
7, patients with central nervous system involvement
8, patients who have already received bendamustine treatment

Target sample size

45

Name of lead principal investigator

1st name
Middle name
Last name	Akifumi Takaori-Kondo

Organization

Kyoto University Hospital

Division name

Department of Hematology/Oncology

Zip code

Address

54 Shogoin-Kawaharacho, Sakyo, Kyoto, 606-8507, JAPAN

TEL

075-751-4964

Email

hemato@kuhp.kyoto-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Toshiyuki Kitano

Organization

Kyoto University Hospital

Division name

Department of Hematology/Oncology

Zip code

Address

54 Shogoin-Kawaharacho, Sakyo, Kyoto, 606-8507, JAPAN

TEL

075-751-4964

Homepage URL

Email

hemato@kuhp.kyoto-u.ac.jp

Institute

Kyoto University Hematology Study Group

Institute

Department

Personal name

Organization

Foundation for Biomedical Research and Innovation

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

京都大学医学部附属病院(京都府)、静岡市立静岡病院(静岡県）、静岡県立総合病院(静岡県）、市立島田市民病院(静岡県）、市立長浜病院(滋賀県)、滋賀県立成人病センター(滋賀県)、大津赤十字病院(滋賀県)、京都市立病院(京都府)、洛和会音羽病院(京都府)、医仁会武田総合病院(京都府)、日本バプテスト病院(京都府)、京都桂病院(京都府)、天理よろづ相談所病院(奈良県)、高の原中央病院(奈良県)、日赤和歌山医療センター(和歌山県)、高槻赤十字病院(大阪府)、大阪赤十字病院(大阪府)、関西電力病院(大阪府)、北野病院(大阪府)、住友病院(大阪府)、県立塚口病院(兵庫県)、県立尼崎病院(兵庫県)、神戸市立医療センター中央市民病院(兵庫県)、神鋼病院(兵庫県)、姫路医療センター(兵庫県)、倉敷中央病院(岡山県)、高松赤十字病院(香川県)、小倉記念病院(福岡県)

Date of disclosure of the study information

2012

Year

06

Month

04

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

No longer recruiting

Date of protocol fixation

2012

Year

05

Month

22

Day

Date of IRB

Anticipated trial start date

2012

Year

06

Month

25

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2012

Year

05

Month

24

Day

Last modified on

2016

Year

11

Month

26

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009438