NCT06630091

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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 participants with newly diagnosed PTCL according to the adverse events graded by CTCAE version 5.0. Exploratory Objectives * To identify participant selection biomarkers derived from tumor and plasma at baseline and correlate these biomarkers with tumor response to golidocitinib. * Evaluate potential mechanisms of resistance to golidocitinib in plasma and tumor biopsies of PTCL participants at baseline and upon progression.

Conditions

• Peripheral T Cell Lymphoma

Interventions

Type	Name	Description
DRUG	Golidocitinib	150 mg once per day by PO
DRUG	Cyclophosphamide	750 mg/m2 by IV
DRUG	Doxorubicin	50 mg/m2 by IV
DRUG	Vincristine	1.4 mg/m2 (max: 2 mg) by IV
DRUG	Prednisone	100 mg by PO

Timeline

• Start date: 2025-02-21
• Primary completion: 2027-07-05
• Completion: 2029-07-05
• First posted: 2024-10-08
• Last updated: 2026-02-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study