Phase II trial of biweekly THP-COP therapy for patients with peripheral T-cell lymphomas.

Phase II trial of biweekly THP-COP therapy for patients with peripheral T-cell lymphomas. - Biweekly THP-COP therapy for peripheral T-cell lymphomas

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000018919

Enrollment

Registered

2015-09-05

Start date

2015-06-01

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

Peripheral T-cell lymphomas (PTCL,nos, AITL, ALK-negative ALCL)

Interventions

Biweekly THP-COP

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Histologically confirmed PTCL,nos, AITL, or ALCL, ALK-negative according to the 2008 WHO classification (2) Age: 15 to 70 years old (3) PS (ECOG): 0-2 (4) No clinical symptoms of CNS involvement (lumbar puncture/head imaging study are not mandatory) (5) Measureable lesion present (6) No prior chemotherapy or radiotherapy for PTCLs. Prior steroid monotherapy for any disease is eligible. Patients with steroid administration for disease except for lymphoma must stop steroid at registration. Short-term steroid administration for lymphoma-associated symptoms such as B symptoms is eligible. (7) The name of disease and prognosis are informed. (8) 1. AST equal or lower than 2.5 UNL 2. ALT equal or lower than 2.5 UNL 3. T-bil equal or lower than 2.0 mg/dL 4. Cr equal or lower than 1.5 mg/dL 5. WBC equal or higher than 3,500 /mm3 6. Hb equal or higher than 10 g/dl 7. Plt equal or higher than 100,000 /mm3 Cases not meeting for above criteria because of lymphoma involvement are eligible. (9) Ejection fraction of left ventricle equal or higher than 50% by echocardiogram. (10) Without arrhythmia or abnormal electrocardiogram needing therapeutic intervention (11) PaO2 equal or higher than 60 mmHg (12) Written informed consent of patient (and parents in minor)

Exclusion criteria

Exclusion criteria: (1) Severe infection, active tuberculosis, uncontrollable diabetes mellitus under insulin treatment, or liver cirrhosis (2) Other active malignancy (except for in situ carcinoma in uterine cervix or basal cell carcinoma) (3) CNS involvement (4) Pregnant or breastfeeding women (5) Severe psychosis (6) HBs antigen positive (7) HBc antibody positive or HBs antibody positive, with HBV-DNA positive (8) HIV antibody positive or HTLV-1 antibody positive (9) Patients with difficult situation for study such as high-risk of gastrointestinal perforation/bleeding or surgical indication

Design outcomes

Primary

Measure	Time frame
3-year progression-free survival rate	—

Secondary

Measure	Time frame
Complete remission rate, Overall survival rate, Toxicity	—

Countries

Japan

Contacts

Public ContactNaoto Tomita

St. Marianna University School of Medicine Division of Hematology and Oncology, Department of Internal Medicine

cavalier@ch-yamate.dlenet.com044-977-8111

Outcome results

None listed

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