Phase 3 Study Comparing Belinostat-CHOP or Pralatrexate-COP Versus CHOP Alone in Newly Diagnosed Peripheral T-Cell Lymphoma Patients

What this Trial Is About

Researchers are evaluating treatments for patients newly diagnosed with Peripheral T-Cell Lymphoma PTCL in a phase 3 study. The trial aims to find the best dose of two drugs, Belinostat and Pralatrexate, combined with chemotherapy regimens CHOP or COP, focusing on safety and effectiveness. The study compares two experimental combinations against the standard CHOP regimen to see which improves progression-free survival in PTCL patients. The study has two parts. Part 1 tests two dose levels of Belinostat with CHOP and Pralatrexate with COP in five groups to determine the safest and most suitable doses. Part 2 randomizes patients into three groups Belinostat plus CHOP, Pralatrexate plus COP, and CHOP alone, with treatments given in up to six cycles spaced 21 days apart. Belinostat and Pralatrexate are administered intravenously with specific schedules alongside chemotherapy drugs. The study includes detailed dosing and administration plans for each group. Participants undergo up to 28 days of screening, followed by treatment cycles lasting about 18 weeks. Tumor assessments occur regularly during treatment and for up to three years after, with follow-up visits every six months until five years. Researchers collect data on progression-free survival, overall survival, and safety. Long-term monitoring includes phone follow-ups to track outcomes. Participants are closely monitored through clinical evaluations, laboratory tests, and imaging throughout the study.

To Evaluate Efficacy of Belinostat or Pralatrexate in Combination Against CHOP Alone in PTCL