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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000002287
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Hematological Malignancy Clinical Study Group
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002737

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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