CEOP/IVE/GDP Compared With CEOP as the First-line Therapy for Newly Diagnosed Adult Patients With PTCL

• Status: Active, not recruiting
• Trial end date: 2020-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Peripheral T-cell Lymphoma (PTCL) is a heterogenic malignancy with poor outcome. Five-year PFS and OS for these patients received classic CHOP regimen (cyclophosphamide, vincristin, doxorubicin and prednisone) is less than 30%.High dose intensive chemotherapy doesn't demonstrate better response. At present, there is no standardized treatment protocol for this kind of lymphoma. So, clinical trials are encouraged by NCCN for those patients.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shandong Provincial Hospital
• Treatments: Cyclophosphamide; Epirubicin; Prednisone; Vincristine

Criteria

Inclusion Criteria:

• Newly diagnosed, histologically confirmed the following pathology subtype according to WHO 2008 classification: peripheral T Cell Lymphoma, not otherwise specified, angioimmunoblastic T cell lymphoma, ALK-negative anaplastic large cell lymphoma, enteropathy associated T cell lymphoma, subcutaneous panniculitis like T cell lymphoma, and hepatosplenic T-cell lymphoma.

• ≥ 16 years of age.

• Performance status of 2 or less.

• Has no history of malignancy.

• Has radiologically measurable disease.

• Life expectancy ≥6 months.

• Voluntarily sign an informed consent.

Exclusion Criteria:

• Pathology subtype with NK/T cell lymphoma, ALK positive-ALCL.

• Primary central nervous system (CNS) lymphoma.

• Previous systemic chemotherapy or local therapy.

• Has undergone hematopoietic stem-cell transplantation (HSCT).

• Has active infectious disease requiring general antibiotics, anti-fungal or anti-virus therapy.

• Has uncontrollable cardiocerebrovascular, coagulative, autoimmune, or serious infectious disease.

• Echocardiography shows left ventricular ejection fraction (LVEF) ≤ 50%.

• Inadequate renal, hepatic or bone marrow function

• Active liver or biliary disease.

• Has other uncontrollable medical condition that may interfere with their participation in the study.

• Woman in pregnancy or lactation.

• Patient is known to be positive for Human immunodeficiency virus (HIV) infection.