UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000009797
Receipt number R000011103
Scientific Title Phase II study of bendamustine, rituximab and cytarabine for patients with relapsed or refractory follicular lymphoma or mantle cell lymphoma
Date of disclosure of the study information 2013/01/17
Last modified on 2022/03/01 22:14:56

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Basic information

Public title

Phase II study of bendamustine, rituximab and cytarabine for patients with relapsed or refractory follicular lymphoma or mantle cell lymphoma

Acronym

GHSG-BRAC

Scientific Title

Phase II study of bendamustine, rituximab and cytarabine for patients with relapsed or refractory follicular lymphoma or mantle cell lymphoma

Scientific Title:Acronym

GHSG-BRAC

Region

Japan


Condition

Condition

relapsed or refractory follicular lymphoma or mantle cell lymphoma

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

YES


Objectives

Narrative objectives1

To evaluate efficacy and safety of bendamustine, rituximab and cytarabine for treatment of relapsed or refractory follicular lymphoma or mantle cell lymphoma.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II


Assessment

Primary outcomes

complete response rate

Key secondary outcomes

overall response rate
event free survival
progression free survival
safty
peripheral blood stem cell harvest (transplant case)


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

BRAC therapy
Rituximab 375mg/sqm Day 1
Bendamustine 90mg/sqm Day 2,3
Cytarabine 600mg/sqm Day 2,3,4
Filgrastim 300ug/m2/day sc after Day 5

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



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit

80 years-old >

Gender

Male and Female

Key inclusion criteria

1) Patients with pathologically confirmed follicular lymphoma or mantle cell lymphoma.
2) Patients had received prior treatment of rituximab in combination with chemotherapy or rituximab alone, and were considered no response or relapse after CR or PR.
3) CD20 positive.
4) Patients have measurable lesion that measured >=1.5cm in a single dimension by CT.
5) Patients aged 20-80 years.
6) PS(ECOG) 0-2
7) Patients meet all following standard
Absolute neutrophil count >= 1,000/mm3
Hemoglobin >= 8.0 g/dL
Platelet count >= 75,000/mm3
AST and ALT < 2.5 times facility criteria.
Total bilirubin < 2.5 times facility criteria.
Creatinine < 1.5 times facility criteria.
Cardiac electro gram: no abnormality required treatment
8) Patients have a life expectancy > 3 months.
9) Written informed consent.

Key exclusion criteria

1) Patients are pregnant or lactating women. Patients (<1 year after menopause without surgical infertility) can not or will not use birth control during the treatment.
2) Patients have active other malignant diseases including simultaneous cancer and disease free state within 5 years after treatment for other cancer except curable intramural cancer by local treatment.
3) Patients have mental disease or disorder with difficulty in participating in the clinical trial.
4) HIV antibody positive, HBs antigen positive, HCV antibody positive
5) Patients have much tumor cell in peripheral blood (>=25,000/mm3).
6) Patients received allogeneic hematopoietic stem cell transplant.
7) Patients have interstitial lung disease or fibroid lung.
8) Patients have CNS invasion.
9) Patients are inappropriate for rituximab treatment.
10) Patients have severe allergic symptoms.
11) Inadequate for clinical trial entry by the attending physicians.

Target sample size

27


Research contact person

Name of lead principal investigator

1st name Nobuhiro
Middle name
Last name Kanemura

Organization

Gifu University Hospital

Division name

First Department of Internal Medicine

Zip code

501-1194

Address

1-1 Yanagido Gifu

TEL

058-230-6008

Email

nkane@orion.ocn.ne.jp


Public contact

Name of contact person

1st name Nobuhiko
Middle name
Last name Nakamura

Organization

Gifu University Hospital

Division name

First Department of Internal Medicine

Zip code

501-1194

Address

1-1 Yanagido Gifu

TEL

058-230-6008

Homepage URL


Email

nnakamura-gif@umin.ac.jp


Sponsor or person

Institute

Gifu University Hospital

Institute

Department

Personal name



Funding Source

Organization

First Department of Internal Medicine, Gifu University Hospital

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

Gifu University Institutional Review Board

Address

1-1 Yanagido Gifu

Tel

058-230-6008

Email

rinri@gifu-u.ac.jp


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

岐阜市民病院(岐阜県)、岐阜赤十字病院(岐阜県)


Other administrative information

Date of disclosure of the study information

2013 Year 01 Month 17 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications

https://ehoonline.biomedcentral.com/articles/10.1186/s40164-022-00264-3

Number of participants that the trial has enrolled

13

Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results

2022 Year 02 Month 25 Day

Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Terminated

Date of protocol fixation

2012 Year 07 Month 09 Day

Date of IRB

2012 Year 07 Month 09 Day

Anticipated trial start date

2012 Year 10 Month 01 Day

Last follow-up date

2021 Year 03 Month 20 Day

Date of closure to data entry

2021 Year 03 Month 20 Day

Date trial data considered complete

2021 Year 03 Month 20 Day

Date analysis concluded

2021 Year 03 Month 20 Day


Other

Other related information



Management information

Registered date

2013 Year 01 Month 17 Day

Last modified on

2022 Year 03 Month 01 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011103


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name