The randomized controlled trial of the THP-COP therapy versus CHOP therapy for T-cell lymphoma with or without P-glycoprotein expression

The randomized controlled trial of the THP-COP therapy versus CHOP therapy for T-cell lymphoma with or without P-glycoprotein expression - 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)

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000004092

Enrollment

Registered

2010-08-24

Start date

2010-02-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

T cell Lymphoma

Interventions

THP-COP therapy 6-8 cycles CHOP therapy 6-8 cycles

Eligibility

Sex/Gender

All

Inclusion criteria

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%

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Remission rate (Complete remission, partial remission)	—

Secondary

Measure	Time frame
The 1-, 3-, 5-year overall survival 50% survival rate The 1-, 3-, 5-year disease free survival	—

Countries

Japan

Contacts

Public ContactHirohiko Shibayama

Osaka University Graduate School of Medicine Department of Hematology and Oncology

hiro@bldon.med.osaka-u.ac.jp06-6879-3871

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026