UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025698 |
|---|---|
| Receipt number | 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 | 2024/12/24 16:12:34 |
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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 | Junji |
| Middle name | |
| Last name | Suzumiya |
Organization
Shimane University
Division name
Shimane University Hospital
Zip code
693-8501
Address
89-1 Enya, Izumo, Shimane 693-8501 Japan
TEL
0853-20-2308
suzumiya@med.shimane-u.ac.jp
Public contact
Name of contact person
| 1st name | Mayumi |
| Middle name | |
| Last name | Tomita |
Organization
Shimane University
Division name
Shimane University Hospital innovative cancer center
Zip code
693-8501
Address
89-1 Enya, Izumo, Shimane 693-8501 Japan
TEL
0853-20-2308
Homepage URL
tomita-m@med.shimane-u.ac.jp
Sponsor or person
Institute
Shimane University
Institute
Department
Personal name
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
Medical Research Ethics Committee, Shimane University Faculty of Medicine
Address
89-1 Enya, Izumo, Shimane 693-8501 Japan
Tel
0853-20-2515
kenkyu@med.shimane-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
| 2017 | Year | 01 | Month | 17 | Day |
Related information
URL releasing protocol
https://pubmed.ncbi.nlm.nih.gov/32880824/
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/32880824/
Number of participants that the trial has enrolled
149
Results
Between January 2007 and December 2015,149 patients diagnosed with aggressive lymphoma who received DA-EPOCH therapy or,in the case of B-cell lymphoma,rituximab combination therapy(hereafter breviated as DA-EPOCH R therapy) in Japan were collected from 17 facilities nationwide and analyzed. The predicted 2-year survival rate for newly diagnosed DLBCL patients was 81%,a favorable result. No effect on prognosis due to differences in dosage was observed.
Results date posted
| 2024 | Year | 12 | Month | 24 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
We retrospectively analyzed 149 patients with aggressive lymphoma who received DA-EPOCH -/+ R between 2007 and 2015 in 17 institutes in Japan.
Participant flow
Patients with malignant lymphoma who underwent DA-EPOCH -/+ R
Adverse events
No adverse events will occur as this is a retrospective study
Outcome measures
These results suggest that DA-EPOCH -/+ R is tolerable and safe in clinical practice.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 09 | Month | 15 | Day |
Date of IRB
| 2016 | Year | 09 | Month | 14 | Day |
Anticipated trial start date
| 2016 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Dose-adjusted EPOCH with or without rituximab for aggressive lymphoma patients: real world data.
Matsuda S, Suzuki R, Takahashi T, Suehiro Y, Tomita N, Izutsu K, Fukuhara N, Imaizumi Y, Shimada K, Nakazato T, Yoshida I, Miyazaki K, Yamaguchi M, Suzumiya J.Int J Hematol. 2020 Dec;112(6):807-816. doi: 10.1007/s12185-020-02984-w. Epub 2020 Sep 3.PMID: 32880824
Management information
Registered date
| 2017 | Year | 01 | Month | 16 | Day |
Last modified on
| 2024 | Year | 12 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029553
