Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 2:26 AM
Study NCT ID:
NCT07414758
Status:
RECRUITING
Last Update Posted:
2026-02-24
First Post:
2026-02-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
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
Organization:
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2026-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
T-START-M1
Brief 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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: