UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002287 |
|---|---|
| Receipt number | R000002737 |
| Scientific Title | A phase2 study of Rituximab+THP-COP(R-THP-COP) in elderly subjects with untreated, advanced, CD20-positive, indolent B-cell Non-Hodgkin's lymphoma |
| Date of disclosure of the study information | 2009/08/03 |
| Last modified on | 2016/08/08 14:46:15 |
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Basic information
Public title
A phase2 study of Rituximab+THP-COP(R-THP-COP) in elderly subjects with untreated, advanced, CD20-positive, indolent B-cell Non-Hodgkin's lymphoma
Acronym
THP2
Scientific Title
A phase2 study of Rituximab+THP-COP(R-THP-COP) in elderly subjects with untreated, advanced, CD20-positive, indolent B-cell Non-Hodgkin's lymphoma
Scientific Title:Acronym
THP2
Region
| Japan |
Condition
Condition
indolent B-cell lymphoma
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety and efficacy of R-THP-COP in elderly subject with CD20-positive,indolent B-cell Non-Hodgkin's lymphoma
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Complete response rate,safty
Key secondary outcomes
overall response rate,progression-free survival,overall survival,safty
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
Rituximab,Cyclophosphamide,Pirarubicin,Vincristine,Prednisolone
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
| 70 | years-old | <= |
Age-upper limit
| 79 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Subjects with diagnosis of CD20-positive,indolent B-cell Non-Hodgkin's lymphoma
2.Age70-79years
3.Eastern Cooperative Oncology Group(ECOG) performance status 0-2
4.
Key exclusion criteria
1.Central nervous system(CNS) NHL
2.Current or chronic hepatitis B or C infection;known seropositiviry for human immunodeficiency virus(HIV).
3.Any evidence of serious active infection
4.Unstable or severe uncontrolled medical condition or any important medical illness or abnormal laboratory finding that would, in the investigator's judgment, increase the risk associated with the subject's participation in the study.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Michinori Ogura |
Organization
Nagoya daini red cross hospital
Division name
hematology
Zip code
Address
2-9 myoukencho,Showa,nagoya,aichi
TEL
052-832-1121
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazunori Ohnishi |
Organization
Hamamatsu University school of Medicine
Division name
Oncology center
Zip code
Address
1-20-1handayama,higashiku,hamamatsu,shizuoka
TEL
053-435-2267
Homepage URL
Sponsor or person
Institute
Hematological Malignancy Clinical Study Group
Institute
Department
Personal name
Funding Source
Organization
Hematological Malignancy Clinical Study Group
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
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
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 08 | Month | 03 | 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
No longer recruiting
Date of protocol fixation
| 2002 | Year | 07 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2005 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 06 | Month | 01 | Day |
Date trial data considered complete
| 2019 | Year | 09 | Month | 01 | Day |
Date analysis concluded
| 2019 | Year | 12 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2009 | Year | 08 | Month | 03 | Day |
Last modified on
| 2016 | Year | 08 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002737
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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