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
M.D. Anderson Cancer Center
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.
Description
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…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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.…
Interventions
- DrugGolidocitinib
150 mg once per day by PO
- DrugCyclophosphamide
750 mg/m2 by IV
- DrugDoxorubicin
50 mg/m2 by IV
- DrugVincristine
1.4 mg/m2 (max: 2 mg) by IV
- DrugPrednisone
100 mg by PO
Location
- MD Anderson Cancer CenterHouston, Texas