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

Study acronym: T-START-M1
StatusRecruiting
PhasePhase 3
Started
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Record History

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  1. Eligibility criteria shortened, about 18 words
    • Study title shortened, about 8 words
    v2
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07414758
Lead Sponsor Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Collaborators: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University, Shanghai Cancer Hospital, China, Ruijin Hospital
Conditions
(from sponsor)		 Peripheral T Cell Lymphoma
Related terms Lymphoma, T-Cell, Peripheral
Enrollment 68 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov