UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015998 |
|---|---|
| Receipt number | R000018257 |
| Scientific Title | Phase II study of gemcitabine, carboplatin and dexamethasone with or without rituximab for patients with relapsed or refractory non-Hodgkin's lymphoma |
| Date of disclosure of the study information | 2014/12/19 |
| Last modified on | 2014/12/19 08:39:53 |
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Basic information
Public title
Phase II study of gemcitabine, carboplatin and dexamethasone with or without rituximab for patients with relapsed or refractory non-Hodgkin's lymphoma
Acronym
GHG-GCD
Scientific Title
Phase II study of gemcitabine, carboplatin and dexamethasone with or without rituximab for patients with relapsed or refractory non-Hodgkin's lymphoma
Scientific Title:Acronym
GHG-GCD
Region
| Japan |
Condition
Condition
relapsed or refractory non-Hodgkin's lymphoma
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate efficacy and safety of gemcitabine, carboplatin and dexamethasone with or without rituximab for patients with relapsed or refractory non-Hodgkin's 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
overall survival
progression free survival
safety
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
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
GCD +/- R therapy
Gemcitabine 1000mg/sqm Day 1,8
Carboplatin AUC5 Day 1
Dexamethasone 40mg Day 1-4
*if CD 20 is positive
Rituximab 375mg/sqm Day 8
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients have pathologically confirmed refractory or relapsed non-Hodgkin lymphoma.
2) Patients had received prior treatment of rituximab in combination with CHOP or THP-COP.
3) Patients aged >= 18 years.
4) ECOG performance status of 0-2
5) Patients have measurable lesion.
6) Patients without interstitial pneumonia or pulmonary fibrosis evidenced by chest X-ray and/or chest CT.
7) Patients have a life expectancy > 12 weeks.
8) Written informed consent.
9) 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.
Key exclusion criteria
1) Patients have CNS invasion.
2) HIV antibody positive.
3) Patients have interstitial pneumonia or pulmonary fibrosis evidenced by chest X-ray and/or chest CT.
4) Patients undergoing chest radiotherapy.
5) Patients have major heart/lung disorders, or uncontrolled diabetes mellitus.
6) Patients are pregnant or lactating women. Patients cannot or will not use birth control during the treatment.
7) Patients have active other malignant diseases.
8) Patients have severe allergic symptoms.
9) Patients have chemotherapy resistant lymphoma.
10) Inadequate for clinical trial entry by the attending physicians.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hisashi Tsurumi |
Organization
Gifu University Hospital
Division name
First Department of Internal Medicine
Zip code
Address
1-1 Yanagido Gifu
TEL
058-230-6000
htsuru@gifu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Junichi Kitagawa |
Organization
Gifu University Hospital
Division name
First Department of Internal Medicine
Zip code
Address
1-1 Yanagido Gifu
TEL
058-230-6000
Homepage URL
http://seesaawiki.jp/ghsg/
jkitagawa1128@gmail.com
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
Address
Tel
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
岐阜大学医学部附属病院（岐阜県）
岐阜県総合医療センター（岐阜県）
岐阜市民病院（岐阜県）
岐阜赤十字病院（岐阜県）
岐北厚生病院（岐阜県）
一宮市立木曽川市民病院（愛知県）
高山赤十字病院（岐阜県）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 12 | Month | 19 | 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
Open public recruiting
Date of protocol fixation
| 2014 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 11 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 12 | Month | 19 | Day |
Last modified on
| 2014 | Year | 12 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018257
