UMIN-CTR Clinical Trial

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

T cell Lymphoma

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO

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

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

Study type

Interventional

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

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

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

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

Email

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

Email

hiro@bldon.med.osaka-u.ac.jp

Institute

Osaka Lymphoma Study Group

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

None

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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

Date of disclosure of the study information

2010

Year

08

Month

24

Day

URL releasing protocol

http://www.olsg.jp/xoops/

Publication of results

Unpublished

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

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 related 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