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
Trial Parameters
Brief Summary
To learn if the study drug golidocitinib given alone or in combination with the standard drug combination therapy called CHOP can help to control PTCL.
Eligibility Criteria
Inclusion Criteria: * Provision of a signed and dated, written informed consent form prior to any study specific procedures, sampling, and analyses. * Submission of the tumor block or unstained slides from an excisional or core biopsy from nodal or extra-nodal lymphoma tissue (archived or newly obtained sample) is required for retrospective central confirmation of tumor histological subtype. * Aged ≥ 18 years old. * Participants must exhibit Eastern Cooperative Oncology Group (ECOG) performance status 0-2 with no deterioration over the previous 2 weeks. * Predicted life expectancy ≥ 12 weeks. * Participants must have histologically confirmed peripheral T-cell lymphoma by MD Anderson pathology review according to the 2016 revision of the World Health Organization classification of lymphoid neoplasms53. Eligible histological subtypes are restricted to the following: * PTCL, not otherwise specified (PTCL, NOS) (the proportion of PTCL-NOS subtype will not exceed 30% of all enrolled) * Angi