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.
The subject must sign the informed consent form (ICF) in accordance with the relevant procedures described in the chapter, and be willing and able to comply with the requirements and restrictions listed in the ICF and this study protocol.
Age >18 years at the time of signing the ICF.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1, with no deterioration within the last 2 weeks.
Histopathologically confirmed diagnosis of PTCL according to the 2016 revised WHO classification of lymphoid neoplasms (Swerdlow SH et al., 2016). Eligible histological subtypes are limited to: PTCL-NOS (excluding primary cutaneous), ALK-negative ALCL, AITL, and follicular helper T-cell lymphoma or PTCL with TFH phenotype (FTCL or PTCL-TFH).
Patients with clinical stage Ann Arbor I disease.
Received any investigational or antitumor drugs in another clinical trial within 30 days prior to the first study dose.
Has not discontinued cytotoxic chemotherapy agents for at least 21 days prior to the first study dose.
Received systemic corticosteroid therapy at a dose >10 mg prednisone equivalent per day within 1 week prior to the first study dose.
Parallel
golidocitinib
DrugEligible patients were randomized to receive golidocitinib medicine orally at a planned dose of 150 mg once every other day.
Placebo
DrugEligible patients were randomized to receive placebo orally at a planned dose of 150 mg once every other day.
Progression-Free Survival (PFS)
PFS means the time from receiving golidocitinib or placebo capsules until the first occurrence of disease progression or death from any cause.
overall survival (OS)
The probability of survival at 1 or 2 years, measured from the date of receiving golidocitinib or matching placebo capsules to death from any cause. Patients who are still alive at the time of analysis will be censored on the last follow-up date.
complete remission rate (CRR)
Complete response rate refers to the proportion of patients who meet the criteria for complete response among all enrolled patients at a specific time point defined by the study.
Time to Next Treatment (TTNT)
TTNT is defined as the time from the initiation of the current therapy to the start of any subsequent antineoplastic treatment or death from any cause.
Duration of Response (DoR)
DOR is defined as the time interval from the date when the patient first meets the criteria for response to the date of the first documented disease progression or death from any cause.
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Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Lead sponsor
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Collaborator
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Collaborator
Shanghai Cancer Hospital, China
Collaborator
Ruijin Hospital
Collaborator
