Dose-intensified pirarubicin-cyclophosphamide, vincristine and prednisolone regimen (Double-THP-COP) followed by consolidative high-dose chemotherapy for peripheral T-cell lymphomas: a prospective phase II trial.

Dose-intensified pirarubicin-cyclophosphamide, vincristine and prednisolone regimen (Double-THP-COP) followed by consolidative high-dose chemotherapy for peripheral T-cell lymphomas: a prospective phase II trial. - Dose-intensified THP-COP regimen (Double-THP-COP) followed by consolidative high-dose chemotherapy for peripheral T-cell lymphomas: a prospective phase II trial.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000012664

Enrollment

Registered

2014-01-01

Start date

2014-01-01

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

Newly diagnosed adult peripheral T cell lymphoma patients, including those with peripheral T-cell lymphoma, not otherwise specified, angioimmunoblastic T-cell lymphoma, anaplastic large cell lymphoma (ALK negative), enteropathy-associated T-cell lymphoma, hepatosplenic T-cell lymphoma.

Interventions

The Double-THP-COP regimen consists of 3 courses of intravenous (i.v.) administration of cyclophosphamide (750 mg/m2, days 1-2, 3h), pirarubicine (40 mg/m2, days 1-2, 30 min), vincristine (1.4 mg/m2,

course 2, 500 mg/m2, days 1-2

and course 3, 750 mg/m2, days 1-2. Treatment intensity is augmented during every course unless leukocyte recovery (WBC count, more than 3,000/ul on day 23) is delayed or an adverse event (more than gr

day -6, -5, and -4

i.v. 6-8 h), and ranimustine (250 mg/m2, day -3 and -2, i.v. 1 h). Autologous stem cell transplantation (ASCT) is performed on day 0 and G-CSF is administered from day 1 until neutrophil engraftment.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients who are diagnosed with PTCLs (by pathological finding) with stage II or more are subject to the study. Also, patients are required to be treated in our hospital. PTCLs includes the subtypes as shown below: Peripheral T-cell lymphoma, not otherwise specified Angioimmunoblastic T-cell lymphoma Anaplastic large cell lymphoma, ALK negative Enteropathy-associated T-cell lymphoma Hepatosplenic T-cell lymphoma

Exclusion criteria

Exclusion criteria: Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 4 serum total Bilirubin > 1.5mg/dl serum creatinine >2.0mg/dl Ejection-Fraction<50% by electrocardiogram If these complications described above are considered to be attributed to underlying disease, those patients are included when the complications are recovered with the standard treatment. Invasion to the central nervous system from the first diagnosis

Design outcomes

Primary

Measure	Time frame
Three years event free survival(EFS)	—

Secondary

Measure	Time frame
Overall response rate (ORR) Complete remission (CR) rate Three or five years disease free survival (DFS) Five years event free survival (EFS) Three or five years overall survival (OS) Incidence and grade of toxicity Influence on outcome by lymphoma prognostic factor (IPI,PIT) Prognostic comparison between AutoPBSCT cases and HD-MTX cases	—

Countries

Japan

Contacts

Public ContactHiromichi Takahashi

Nihon University School of Medicine Itabashi Hospital Department of Hematology and Rheumatology

hitakahashi-nhn@umin.ac.jp03-3972-8111

Outcome results

None listed

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