Newly diagnosed peripheral T-cell lymphoma (PTCL), including but not limited to: Peripheral T-cell lymphoma, not otherwise specified (PTCL-NOS) Angioimmunoblastic T-cell lymphoma (AITL) Anaplastic large cell lymphoma, ALK-negative (ALK- ALCL) Anaplastic large cell lymphoma, ALK-positive (ALK+ ALCL) Enteropathy-associated T-cell lymphoma (EATL) Monomorphic epitheliotropic intestinal T-cell ly
Conditions
Interventions
Test group:Golidocitinib
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Subjects must voluntarily agree to participate in the clinical study; fully understand and provide informed consent by signing the Informed Consent Form (ICF); demonstrate willingness and ability to comply with all study procedures. 2. Histologically confirmed PTCL (based on routine immunohistochemical markers including CD2, CD3, CD4, CD5, CD7, CD8, CD10, CD20, CD30, CD43, CD56, PD1, CXCL13, ALK, TIA-1, granzyme B, Ki-67, PAX5, or CD19/CD21) classified according to the 2022 WHO classification of lymphoid neoplasms, with no prior systemic anti-lymphoma therapy. Eligible subtypes include: Peripheral T-cell lymphoma, not otherwise specified (PTCL-NOS) [Diagnosis applies when criteria for specific PTCL subtypes are unmet]. Angioimmunoblastic T-cell lymphoma (AITL) [Requires CD3/CD4 expression plus =2 T-follicular helper (TFH) markers]. ALK-negative anaplastic large cell lymphoma (ALK- ALCL) [Diffuse CD30+ with variable loss of T-cell markers]. ALK-positive anaplastic large cell lymphoma (ALK+ ALCL) [Diffuse CD30+ with ALK protein overexpression and variable loss of T-cell markers]. Enteropathy-associated T-cell lymphoma (EATL) [CD8-, CD56-, CD30+]. Monomorphic epitheliotropic intestinal T-cell lymphoma (MEITL) [CD3+, CD5-, CD4-, CD8+, CD30-, CD43+, CD56+, TIA-1+, EBER-]. Hepatosplenic T-cell lymphoma (HSTCL) [TCR?d+, CD2+, CD3+, CD4-, CD5-]. Subcutaneous panniculitis-like T-cell lymphoma (SPTCL) [CD3+, CD4-, CD8+ with cytotoxic protein expression]. 3. Measurable/Evaluable Disease: At least one measurable or evaluable lesion per Lugano 2014 criteria: Measurable: Long axis >1.5 cm and short axis >1.0 cm (nodal lesions on CT/MRI); >1.0 cm (extranodal lesions). Evaluable: FDG-avid lesion (PET/CT uptake > liver background) with radiologic features consistent with lymphoma. 4. Age: >=18 and 12 weeks. 6. Performance Status: Eastern Cooperative Oncology Group (ECOG) score 0-1. 7. Adequate Organ Function: Hematologic: Absolute neutrophil count (ANC) >=1.5×10?/L (=1.0×10?/L if bone marrow involvement). Platelets (PLT) >=75×10?/L (=50×10?/L if bone marrow involvement). Hemoglobin (HGB) >=80 g/L (no transfusion or growth factor support within 14 days). Hepatic: Total bilirubin (TBIL) =1.5×ULN (=50 mL/min (Cockcroft-Gault formula). Coagulation: INR =50% by MUGA or echocardiography (ECHO). 8. Cardiac Function: Left ventricular ejection fraction (LVEF) >=50% by MUGA or echocardiography (ECHO). 9. Contraception: Women of childbearing potential (WOCBP) must have a negative serum pregnancy test within 7 days prior to treatment initiation. Both WOCBP and male subjects with WOCBP partners must use effective contraception from ICF signing until 6 months post-treatment.
Exclusion criteria
Exclusion criteria: 1. Extranodal NK/T-cell lymphoma. Mature T-cell or NK-cell leukemia. 2. Active or history of hemophagocytic lymphohistiocytosis (HLH). 3. Lymphoma involving the central nervous system (CNS) or meninges. 4. History of malignancy within the past 5 years or concurrent malignancy (exempting basal cell carcinoma of the skin). 5. Prior Therapies: Cumulative anthracycline exposure >200 mg/m² doxorubicin (or equivalent dose of epirubicin, daunorubicin, mitoxantrone) using standard anthracycline equivalence tables. First-line chemotherapy regimens other than CHOP or CHOP-containing regimens combined with: Small-molecule agents (e.g., chidamide, linperlisib). Monoclonal antibodies (e.g., brentuximab vedotin, PD-1/PD-L1 inhibitors). Prior radiotherapy for PTCL (excluding localized palliative radiation). Prior use of JAK or STAT3 inhibitors. Concomitant use of CYP3A strong inducers (within 3 weeks) or strong inhibitors (within 1 week) prior to the first dose. Current use of vitamin K antagonists, antiplatelet agents, or anticoagulants (unless discontinued >=1 week prior to enrollment). Investigational drug use within 30 days prior to study entry. Live vaccines administered within 28 days prior to enrollment (exempting live attenuated influenza vaccines). 6. Active Infections: Active/latent tuberculosis (positive tuberculin skin test [PPD >=10 mm induration] or radiologic evidence on chest X-ray/CT). HIV infection/AIDS. Active hepatitis B (HBsAg+ or HBcAb+ with HBV DNA =1,000 IU/mL) or hepatitis C (HCV antibody+). Active infection requiring systemic therapy within 14 days (e.g., pneumonia). 7. Cardiovascular Disease: NYHA class >II heart failure. Unstable angina. Myocardial infarction within 1 year. Clinically significant supraventricular or ventricular arrhythmias requiring intervention. 8. Interstitial Lung Disease: History of interstitial lung disease (except radiation-induced and asymptomatic cases). 9. Adverse events >CTCAE grade 1 (excluding alopecia) persisting at baseline. 10. Known hypersensitivity to golidocitinib, capsule excipients, or structurally similar compounds. 11. Uncontrolled nausea/vomiting, chronic gastrointestinal diseases, dysphagia, or intestinal resection affecting drug absorption. 12. Pregnancy, breastfeeding, or refusal to use contraception. 13. Psychiatric or Legal Issues: Psychiatric disorders impairing judgment. Inability to provide informed consent. 14. Any condition deemed unsuitable for study participation by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete Respond Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| progression-free survival; | — |
Countries
China
Contacts
Public ContactNiu Ting
West China Hospital of Sichuan University
Outcome results
None listed