UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000025698
Receipt No. R000029553
Scientific Title A retrospective study of DA-EPOCH with or without rituximab therapy for aggressive lymphoma
Date of disclosure of the study information 2017/01/17
Last modified on 2017/01/16

* 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 A retrospective study of DA-EPOCH with or without rituximab therapy for aggressive lymphoma
Acronym COPEARL5
Scientific Title A retrospective study of DA-EPOCH with or without rituximab therapy for aggressive lymphoma
Scientific Title:Acronym COPEARL5
Region
Japan

Condition
Condition Malignant Lymphoma
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Verification of efficacy and safety of DA-EPOCH with or without rituximab therapy for aggressive lymphoma
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 4-year overall survival
Key secondary outcomes Safety (Incidence of hematological toxicities, non-hematological toxicities including febrile neutropenia and etc.)

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
16 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Patients treated with DA-EPOCH with or without rituximab therapy as first or second line therapy
2) Aggressive B-cell lymphoma (primary or relapsed/refractory) including hisitologic transformation of indolent B-cell lymphoma
3) Peripheral T-cell lymphoma (diagnosed by WHO classification 2008)
4) Permission from each institute such as IRB
5) Patients over the age of 16 years
6) DA-EPOCH(R) therapy was done between January 1, 2007 and December 31, 2015
Key exclusion criteria Primary CNS lymphoma
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Junji Suzumiya
Organization Shimane University
Division name Shimane University Hospital
Zip code
Address 89-1 Enya, Izumo, Shimane 693-8501 Japan
TEL 0853-20-2308
Email suzumiya@med.shimane-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Junji Suzumiya
Organization Shimane University
Division name Shimane University Hospital
Zip code
Address 89-1 Enya, Izumo, Shimane 693-8501 Japan
TEL 0853-20-2308
Homepage URL
Email suzumiya@med.shimane-u.ac.jp

Sponsor
Institute Shimane University
Institute
Department

Funding Source
Organization Shimane University
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
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
2017 Year 01 Month 17 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
Date of protocol fixation
2016 Year 09 Month 15 Day
Date of IRB
Anticipated trial start date
2016 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 Course number of therapy, efficacies of therapy, adverse events

Management information
Registered date
2017 Year 01 Month 16 Day
Last modified on
2017 Year 01 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029553

Research Plan
Registered date File name
2017/07/18 臨床研究計画書COPEARL5_ver.1.2.pdf

Research case data specifications
Registered date File name
2017/07/18 臨床研究 COPEARL5 調査表 最終2.xlsx

Research case data
Registered date File name


Contact us.