Trial intelligence / Profile preview

Golidocitinib Maintenance in Peripheral T-Cell Lymphoma

NCT07300514Phase 3

Key facts

Status: Recruiting
Start: Mar 2026
Primary completion: Dec 2028
Countries: 1
Sponsor: Fudan University
Modality: Small Molecules

Drugs: golidocitinib
Conditions: peripheral T-cell lymphoma (PTCL)

Overview

Phase 3, randomised, double-blind trial in peripheral T-cell lymphoma (PTCL) comparing Arm A - Experimental: Golidocitinib with Arm B - Placebo Comparator: Placebo (2 arms). Primary endpoint: Progression-free Survival. Started Mar 2026; status: recruiting.

Design

2 arms

Study design: RandomizedDouble-blind

Arm A - Experimental: Golidocitinib
Golidocitinib 150 mg orally every other day
Arm B - Placebo Comparator: Placebo
Matching placebo capsules orally every other day

Who it enrols

Adults with specific subtypes of PTCL in CR or PR after first-line chemotherapy, ineligible for or declining HSCT, with adequate organ function and no prior JAK/STAT3 inhibitors.

Endpoints

Primary

Progression-free Survivalup to approximately 3 years

Secondary

Overall Survivalup to approximately 5 years
Complete Response Rateup to 24 months
Duration of Responseup to approximately 3 years
Time to Next Anti-lymphoma Therapyup to approximately 3 years
MRD Negativity Rate by ctDNA12 months
Incidence of Treatment-emergent Adverse Eventsup to 28 days after the last dose

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