NCT06855823

A Phase I/II Study of Golidocitinib Combined with Pomalidomide in R/R PTCL

A Phase I/II, Open-Label Clinical Trial to Evaluate the Efficacy and Safety of Golidocitinib As Monotherapy or in Combination with Pomalidomide for the Treatment of Relapsed/Refractory Peripheral T-Cell Lymphoma (R/R PTCL)

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 33 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is a phase I/II clinical trial to evaluate the efficacy and safety of Golidocitinib combined with Pomalidomide for relapsed/refractory peripheral T-cell lymphoma.

Detailed description

This clinical trial aims to investigate the efficacy and safety of Golidocitinib combined with Pomalidomide in treating relapsed/refractory peripheral T-cell lymphoma (R/R PTCL). The study is a prospective, open-label, phase I/II clinical trial initiated by investigators. It plans to enroll approximately 26-33 patients who have not previously received Golidocitinib or Pomalidomide. The primary endpoint for phase I is to assess the dose-limiting toxicity (DLT) of Pomalidomide in combination with Golidocitinib, estimate the maximum tolerated dose (MTD), and determine the recommended phase II dose (RP2D). For phase II, the primary endpoint is to evaluate the objective response rate (ORR) of the combination therapy. Secondary endpoints include duration of response (DOR), complete response rate (CR), progression-free survival (PFS), overall survival (OS), time to response (TTR), and safety indicators. The study will provide valuable data on the potential benefits and risks of this novel combination therapy for R/R PTCL patients.

Conditions

• Relapsed/Refractory Peripheral T-Cell Lymphoma (R/R PTCL)

Interventions

Type	Name	Description
DRUG	Golicitinib combined with Pomadomide	golidoctinib 150 mgqd, pomalidomide 2mg/3mg/4mgqd

Timeline

• Start date: 2025-01-14
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2025-03-04
• Last updated: 2025-03-04

Locations

1 site across 1 country: China