A multicenter phase II study for previouly untreated advanced stage peripheral T-cell lymphoma evaluating efficacy and safety of combination chemotherapy with THP-COP regimen

A multicenter phase II study for previouly untreated advanced stage peripheral T-cell lymphoma evaluating efficacy and safety of combination chemotherapy with THP-COP regimen - A phase II study of THP-COP therapy for previouly untreated advanced stage peripheral T-cell lymphoma.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000014902

Enrollment

Registered

2014-08-20

Start date

2007-10-07

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

previouly untreated advanced stage peripheral T-cell lymphoma

Interventions

Chemotherapy (Age20-69: 8 cycles and 70-79: 6 cycles of R-THP-COP therapy)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Histological confirmed Peripheral T-cell lymphoma including unspecified (PTCL-u), Angioimmunoblatic T-cell lymphoma (AITL) and Anaplastic large cell lymphoma (ALCL) excluding ETL, HSTCL, SPTCL and ATLL (WHO) 2. Clinical stage of bulky II, III or IV according to Ann Arbor classification 3. Aged 20-79 years 4. Performance status of 0-2 5. Presence of measurable lesion(s) 6. No prior chemotherapy, radiotherapy, interferon and/or antibody therapy 7. Patients with sufficient organ functions 8. Patient's written informed consent

Exclusion criteria

Exclusion criteria: 1. Presence of central nervous involvement (clinical or pathological) 2. Diabetes mellitus receiving insulin therapy 3. Uncontrollable hypertension 4. History of angina pectoris or myocardial infarction. Comorbidity of cardiomyopathy. Arrhythmia on treatment with antiarrhythmic agents 5. Positive test for HBs antigen 6. Positive test for HCV antibody 7. Positive test for HIV antibody 8. Accompanying interstitial pneumonitis, pulmonary fibrosis or severe emphysema diagnosed by chest X-ray 9. Severe infection 10. Biopsy proven or clinically diagnosed Liver cirrhosis 11. Active double cancer: overlapping cancer or asynchronous cancer within 5 years. Carcinoma in situ, intramucosal cancers, and other equivalent lesions are not included for the active double cancer 12. Use of major tranquilizer, antidepressant or antimanic drugs 13. Severe psychosis

Design outcomes

Primary

Measure	Time frame
complete response rate, %CR	—

Secondary

Measure	Time frame
1) short-term safety 2) response rate (%RR) 3) 1year progression-free survival (1-y PFS) 4) 1year overall survival (1-y OS) 5)long-term safety	—

Countries

Japan

Contacts

Public ContactMichinori Ogura

Hematological Malignancy Study Group Hematological Malignancy Study Group

mi-ogura@naa.att.ne.jp059-378-1321

Outcome results

None listed

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