UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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
Title of the study (Brief title)	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	Michinori Ogura
Organization	Nagoya daini red cross hospital
Division name	hematology
Address	2-9 myoukencho,Showa,nagoya,aichi
TEL	052-832-1121
Email

Public contact
Name of contact person	Kazunori Ohnishi
Organization	Hamamatsu University school of Medicine
Division name	Oncology center
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)

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

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2002 Year 07 Month 11 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000002737