UMIN-CTR Clinical Trial

Public title

Phase II study to evaluate efficacy and safety of retherapy with bendamustine and rituximab regimens in patients with relapsed/refractory indolent B-cell lymphomas and mantle cell lymphomas

Acronym

B-SRIM Study

Scientific Title

Phase II study to evaluate efficacy and safety of retherapy with bendamustine and rituximab regimens in patients with relapsed/refractory indolent B-cell lymphomas and mantle cell lymphomas

Scientific Title:Acronym

B-SRIM Study

Region

Japan

Condition

relapsed/refractory indolent B-cell lymphomas and mantle cell lymphomas

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To evaluate efficacy and safety of retherapy with bendamustine and rituximab regimens in patients with relapsed/refractory indolent B-cell lymphomas and mantle cell lymphomas

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

overall response rate (ORR)

Key secondary outcomes

1. complete response rate (CRR)
2. progression free survival (PFS)
3. safety
4. evaluation of efficacy and safety for each regimens

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

rituximab 375 mg/m2 (Day1)+bendamustine 90 mg/m2 (Day1, Day2)
Typically, courses are administered at an interval of 28 days (a maximum of 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

85

years-old

>

Gender

Male and Female

Key inclusion criteria

1. Patients who have been diagnosed as histologically confirmed low-grade B cell non-Hodgkin's lymphoma or mantle cell lymphoma. Typically, a re-biopsy is required for histological diagnosis at the time of a recurrence.
2. Patients who have received bendamustine containing chemotherapy
3. Patients who have maintained response (greater than PR) to the last bendamustine containing regimen for over 6 months
4. Patients who have at least one measurable disease (> 1.5cm diameter) with CT scanning
5. Patients over 20 years old and less than 85 years old (at the registration)
6. Patients whose performance status are 0-2 by ECOG criteria
7. Patients who meet all of the following condition
Neutrophil >= 1,000 /mm3
Hb >= 8.0g /dL
Plt >= 75,000 /mm3
AST, ALT < x 2.5 ULN
T-Bil =< 2.0 mg/dl
Cr =< 2.0 mg/dl
8. Patients who are evaluated to survive more than three months
9. Patients who give written informed consent following sufficient explanation.

Key exclusion criteria

1. Patients who are pregnant or in the location period, and who are not able to, or not willing to prevent conception during the therapeutic period of this clinical study
2. Patients who have coinciding active cancer
3. Patients who have psychiatric disorder
4. Patients who have circulating lymphoma cells >= 25,000 /uL in peripheral blood
5. Patients who have interstitial pneumonia or pulmonary fibrosis
6. Patients who have central nerve system lymphoma
7. Patients who have severe allergic reaction to medication
8. Patients who are considered as inappropriate to register by physician

Target sample size

38

Name of lead principal investigator

1st name
Middle name
Last name	Fumihiko Kimura

Organization

National Defense Medical College

Division name

Division of Hematology

Zip code

Address

3-2, Namiki, Tokorozawa, Saitama

TEL

04-2995-1617

Email

fkimura@ndmc.ac.jp

Name of contact person

1st name
Middle name
Last name	Shinichi Kobayashi

Organization

National Defense Medical College

Division name

Division of Hematology

Zip code

Address

3-2, Namiki, Tokorozawa, Saitama

TEL

04-2995-1617

Homepage URL

Email

kobashin@ndmc.ac.jp

Institute

B-SRIM Study Group

Institute

Department

Personal name

Organization

N/A

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

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

Date of disclosure of the study information

2013

Year

07

Month

11

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

Enrolling by invitation

Date of protocol fixation

2013

Year

06

Month

20

Day

Date of IRB

Anticipated trial start date

2013

Year

07

Month

11

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2013

Year

07

Month

09

Day

Last modified on

2014

Year

05

Month

03

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013048