M.D. Anderson Cancer Center
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.
Primary Objectives • To assess the 2-year progression-free survival rate of golidocitinib as primary efficacy endpoint in participants with newly diagnosed PTCL. Secondary Objectives * To assess the anti-tumor efficacy of golidocitinib using PET/CT-based objective response rate (ORR), complete response rate (CRR), duration of response (DoR), progression-free survival (PFS), and time to response (TTR) assessed according to the 2014 Lugano classification as secondary efficacy endpoint in patients with newly diagnosed PTCL. * To assess the safety and tolerability of golidocitinib in participan…
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.…
150 mg once per day by PO
750 mg/m2 by IV
50 mg/m2 by IV
1.4 mg/m2 (max: 2 mg) by IV
100 mg by PO
Arctuva estimate
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