Phase II Study of Golidocitinib Alone or with CHOP in Newly Diagnosed Peripheral T Cell Lymphoma Patients

What this Trial Is About

Researchers are evaluating golidocitinib, given alone or with the standard CHOP chemotherapy, in patients newly diagnosed with peripheral T-cell lymphoma PTCL. This phase II study aims to assess how well golidocitinib controls the disease by measuring progression-free survival over two years, along with other measures of tumor response and safety. The study also explores biomarkers in tumor and plasma samples to understand response and resistance mechanisms. The treatment involves giving golidocitinib orally at 150 mg daily as a single agent or every other day when combined with CHOP chemotherapy, which includes cyclophosphamide, doxorubicin, vincristine, and prednisone. Dose adjustments may be made based on side effects. This single-center, single-arm study monitors participants throughout treatment and evaluates them with imaging and clinical assessments. Participants will undergo regular evaluations including imaging with PETCT scans to assess tumor response, blood tests for safety and biomarker analysis, and monitoring for side effects graded by standard criteria. The main outcome is safety and adverse events tracked over about one year. The study requires participant commitment to follow-up visits and adherence to study procedures, with an overall participation period extending to the study completion around 2029.

A Phase II, Single-center, Single-arm Study Evaluating the Safety and Efficacy of Golidocitinib in the Management of Newly Diagnosed Peripheral T Cell Lymphoma Patients (GOLDEN Study) and Correlative Study