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
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).
• Subjects must have achieved a Complete Response (CR) or Partial Response (PR) as assessed by the Lugano 2014 criteria following first-line systemic standard therapy (limited to CHOP, BV-CHP, or CHOP-like regimens), and are either transplant-ineligible (age \>65 years) or transplant-eligible (age ≤65 years) but have provided written refusal for transplantation. The time from the end of initial therapy to the planned first dose in this study must be ≤3 months.
• Adequate bone marrow and organ function, as defined below:
‣ Absolute neutrophil count (ANC) ≥1.5 × 10⁹/L (≥1.0 × 10⁹/L in case of bone marrow involvement by lymphoma). Subjects must not have used colony-stimulating factors within 7 days prior to study entry.
⁃ Platelet count ≥100 × 10⁹/L (≥75 × 10⁹/L in case of bone marrow involvement by lymphoma). Subjects must not have received transfusion or thrombopoietic agents within 7 days prior to study entry.
⁃ Hemoglobin ≥10 g/dL.
⁃ Total bilirubin ≤2 × Upper Limit of Normal (ULN).
⁃ Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 × ULN.
⁃ Serum creatinine ≤1.5 × ULN, OR calculated or measured creatinine clearance (Cockcroft-Gault formula) ≥50 mL/min, OR a 24-hour urine collection demonstrating a creatinine clearance ≥50 mL/min.
• Left ventricular ejection fraction (LVEF) ≥50% as measured by echocardiogram (ECHO).
• Voluntarily participate in the clinical study; fully understand and are informed about this study and sign the ICF; willing and able to follow and complete all trial procedures.