UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004092 |
|---|---|
| Receipt number | R000004927 |
| Scientific Title | The randomized controlled trial of the THP-COP therapy versus CHOP therapy for T-cell lymphoma with or without P-glycoprotein expression |
| Date of disclosure of the study information | 2010/08/24 |
| Last modified on | 2010/08/24 12:04:43 |
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Basic information
Public title
The randomized controlled trial of the THP-COP therapy versus CHOP therapy for T-cell lymphoma with or without P-glycoprotein expression
Acronym
The randomized controlled trial of the THP-COP therapy versus CHOP therapy for T-cell lymphoma with or without P-glycoprotein expression (OLSG10-01 clinical trial)
Scientific Title
The randomized controlled trial of the THP-COP therapy versus CHOP therapy for T-cell lymphoma with or without P-glycoprotein expression
Scientific Title:Acronym
The randomized controlled trial of the THP-COP therapy versus CHOP therapy for T-cell lymphoma with or without P-glycoprotein expression (OLSG10-01 clinical trial)
Region
| Japan |
Condition
Condition
T cell Lymphoma
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate efficacy and safety of the THP-COP therapy in comparison to the CHOP therapy for T-cell Lymphoma.
Moreover, effectiveness and safety by P-glycoprotein expression situation are examined as a subset analysis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase II,III
Assessment
Primary outcomes
Remission rate (Complete remission, partial remission)
Key secondary outcomes
The 1-, 3-, 5-year overall survival
50% survival rate
The 1-, 3-, 5-year disease free survival
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
THP-COP therapy 6-8 cycles
Interventions/Control_2
CHOP therapy 6-8 cycles
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Peripheral T cell lymphoma patients (PTCL-NOS, AITL, ALCL) with written informed consent
2)diagnosed as T cell lymphoma (PTCL-NOS, AITL, ALCL) by the pathological central review
3)without severe complication
4)having measurable disease
5)PS 0-2
6)Patients satisfied with the following clinical laboratory test criteria
-WBC count more than 3,000/mm3
(absolute neutrophil count more than 1,500/mm3)
-Platelet count more than 75,000/mm3
-Hb level more than 10g/dl
-AST and ALT less than X2.5 the normal upper limit
-total bilirubin less than 1.5mg/dl
-creatinin less than institutional standard
-normal ECG
-UCG: LVEF more than 60%
Key exclusion criteria
1)Previously treated patients
2)Other active multiple cancers
3)Severe complications (liver, kidney, cardiac disease, infection, etc)
4)Severe cardiac disfunction
5)History of angina pectoris, myocardial infarction
6)pregnant women and women suspected to be pregnant
7)HBV carrier (hepatitis B surface antigen positivity, HBc antibody positive or HBs antibody positivity), HCV positivity
8)HTLV-1 positivity
9)HIV positivity
10)History of severe drug hypersensitivity
11)judged to be inappropriate for other reasons by physician
Target sample size
94
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuzuru Kanakura |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Hematology and Oncology
Zip code
Address
2-2 Yamadaoka, Suita, Osaka 565-0871, Japan
TEL
06-6879-3871
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hirohiko Shibayama |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Hematology and Oncology
Zip code
Address
2-2 Yamadaoka, Suita, Osaka 565-0871, Japan
TEL
06-6879-3871
Homepage URL
hiro@bldon.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka Lymphoma Study Group
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
None
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
大阪大学医学部附属病院（大阪府）
大阪市立大学附属大学（大阪府）
関西医科大学附属病院（大阪府）
兵庫医科大学附属病院（兵庫県）
大阪府立成人病センター（大阪府）
大阪市立総合医療センター（大阪府）
市立堺病院（大阪府）
住友病院（大阪府）
松下記念病院（大阪府）
八尾市立病院（大阪府）
市立池田病院（大阪府）
箕面市立病院（大阪府）
大手前病院（大阪府）
淀川キリスト教病院（大阪府）
兵庫県立西宮病院（兵庫県）
関西労災病院（兵庫県）
ほか大阪リンパ腫研究会参加施設
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 08 | Month | 24 | Day |
Related information
URL releasing protocol
http://www.olsg.jp/xoops/
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
Open public recruiting
Date of protocol fixation
| 2009 | Year | 11 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 02 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 08 | Month | 24 | Day |
Last modified on
| 2010 | Year | 08 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004927
