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RECRUITING
NCT07414758
PHASE3

Golidocitinib Versus Placebo as Maintenance Therapy in PTCL Patients With Response (CR/PR) After First-Line Chemotherapy

Sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

View on ClinicalTrials.gov

Summary

This is a multicenter, randomized, double-blind, phase III clinical study comprising two arms: a golidocitinib group and a placebo group. The study aimed to evaluate the antitumor efficacy and safety of golidocitinib in patients who had achieved a response after first-line systemic therapy and were ineligible for hematopoietic stem cell transplantation. The investigational intervention consisted of either golidocitinib or matching placebo capsules, administered orally at a planned dose of 150 mg once every other day. Treatment continued until disease progression, initiation of new anti-lymphoma therapy, withdrawal of informed consent, death, or investigator decision to discontinue the study, whichever occurred first. The study treatment period was divided into 28-day cycles starting from the first dose. Efficacy and safety assessments were performed at specified time points within each cycle. The maximum duration of treatment was 2 years. A total of 136 patients were enrolled, with 68 patients assigned to the golidocitinib treatment group and 68 to the placebo control group. Data on demographics and medical history were collected, and assessments including vital signs, physical examination, and PET-CT were conducted.

Official title: Golidocitinib Versus Placebo as Maintenance Therapy in Peripheral T-Cell Lymphoma Patients With Response (CR/PR) After First-Line Chemotherapy: A Multicenter, Randomized, Double-Blind, Phase III Clinical Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

68

Start Date

2026-02-15

Completion Date

2029-09-30

Last Updated

2026-02-24

Healthy Volunteers

No

Interventions

DRUG

golidocitinib

Eligible patients were randomized to receive golidocitinib medicine orally at a planned dose of 150 mg once every other day.

DRUG

Placebo

Eligible patients were randomized to receive placebo orally at a planned dose of 150 mg once every other day.

Locations (1)

Shanghai General hospital,Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China