UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011604 |
|---|---|
| Receipt number | R000013098 |
| Scientific Title | Anti-tumor effect and safety of GDP therapy (gemcitabine, dexamethasone, and cisplatin) in patients with relapsed or refractory non-Hodgkin lymphoma |
| Date of disclosure of the study information | 2013/09/01 |
| Last modified on | 2021/08/25 16:53:01 |
* 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
Anti-tumor effect and safety of GDP therapy (gemcitabine, dexamethasone, and cisplatin) in patients with relapsed or refractory non-Hodgkin lymphoma
Acronym
Anti-tumor effect and safety of GDP therapy (gemcitabine, dexamethasone, and cisplatin) in patients with relapsed or refractory non-Hodgkin lymphoma
Scientific Title
Anti-tumor effect and safety of GDP therapy (gemcitabine, dexamethasone, and cisplatin) in patients with relapsed or refractory non-Hodgkin lymphoma
Scientific Title:Acronym
Anti-tumor effect and safety of GDP therapy (gemcitabine, dexamethasone, and cisplatin) in patients with relapsed or refractory non-Hodgkin lymphoma
Region
| Japan |
Condition
Condition
relapsed or refractory non-Hodgkin lymphoma
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Therapeutic efficacy and safety of GDP therapy (Gemcitabine, Dexamethasone, and Cisplatin) have not ever been estimated in this country. Improvement in overall survival and progression free survival by GDP therapy can generate another therapeutic choice in relapsed or refractory no Hodgkin lymphoma.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Promary endpoint
Overall responsive rate
Primary endpoint is determined to be an overall responsive rate of GDP therapy evaluated according to IWRC.
Key secondary outcomes
Secondary endpoints
1) CRrate
2) Progression free survival
3) Therapeutic efficacy and safety of GDP therapy are estimated compared with those of historical control.
4) Adverse effect
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Gemcitabine 1000mg/m2, Day1, 8
Dexamethasone 40mg/body, Day1-4
Cisplatin 75mg/m2, Day1
Rituximab 375mg/m2, Day1, 8
Up to 8 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
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) non-Hodgkin lymphoma(aged 20 or older)
2) measurable lesion(s)
3) antecedent treatment(s)
4) 6 months or more in estimated survival
5) 0-2 in Performance Status
6) well preserved organic function
7) written consent
Key exclusion criteria
1) Received a gemcitabine previously
2) Allergic experience to rituximab or mouse proteins in the case of administration of rituximab
3) Pulmonary fibrosis or interstitial pneumonia detected within 28 days
4) Serious heart disease
5) Serious digestive symptoms
6) Body cavity fluid requiring treatment
7) Severe bone marrow suppression
8) Active infection
9) Serologically positive for HBsAg, HCVAb, or HIVAb
10) Severe bleeding tendency
11) Symptomatic brain metastasis
12) Critical complication
13) Serious mental disease
14) Active malignancy concomitantly existed
15) Auto immune hemolytic anemia
16) Lactating women, pregnant women and women suspected of being pregnant
17) Disagreement on intercourse without contraception
18) Ineligibility owing to the decision of doctor involved in this trial
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | Tatsuo |
| Middle name | |
| Last name | Ichinohe |
Organization
Research Institute for Radiation Biology and Medicine
Division name
Dept of Hematology and Oncology
Zip code
734-8553
Address
1-2-3 Kasumi Minami-ku Hiroshima, Japan
TEL
082-257-5555
nohe@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Keichiro |
| Middle name | |
| Last name | Mihara |
Organization
Hiroshima University
Division name
Dept of Hematology and Oncology
Zip code
734-8553
Address
1-2-3 Kasumi Minami-ku Hiroshima, Japan
TEL
082-257-5555
Homepage URL
kmmihara@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University
Institute
Department
Personal name
Funding Source
Organization
Hiroshima University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hiroshima University
Address
1-2-3 Kasumi Minami-ku Hiroshima Japan
Tel
028-257-5555
byo-keiei-tiken@office.hiroshima-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
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 09 | Month | 01 | 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
Completed
Date of protocol fixation
| 2013 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2012 | Year | 06 | Month | 01 | Day |
Anticipated trial start date
| 2013 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 08 | Month | 30 | Day |
Last modified on
| 2021 | Year | 08 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013098
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
