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 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
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
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
