DZ2022J0004

A Phase 3, Open-Label, Randomized, Multinational Study to Investigate the Anti-tumor Efficacy of Golidocitinib Versus Investigator's Choice in Adult Patients With Relapsed/Refractory Peripheral T-cell Lymphoma

LymphomaNCT07234162Last updated: 3/2/2026
Recruiting

Study Design

Study Drug

Golidicitinib

Mechanism of Action

JAK 1

Sponsor

Dizal (Jiangsu) Pharmaceutical Co., Ltd.

Design

Phase 3, open-label, randomized, multinational study

Control Arm

Pralatrexate, Belinostat, Gemcitabine, Chidamide

Criteria

Inclusion Criteria

Adults (>=18) with histologically confirmed r/r PTCL subtype, ECOG 0–2, prior systemic therapy failure/intolerance (with subtype-specific prior-therapy requirements), transplant-ineligible

Participants must meet all of the following: 1. Signed ICF and ability to comply with protocol requirements/restrictions. 2. Age >=18 years at ICF signing. 3. ECOG performance status 0-2 without deterioration in the prior 2 weeks. 4. Life expectancy >=12 weeks. 5. Histologically confirmed PTCL by site per WHO criteria; eligible subtypes include: - PTCL-NOS, - AITL, - ALCL ALK+, - ALCL ALK-, - FTCL/PTCL-TFH, - EATL, - MEITL, - NK/TCL, - HSTCL, - SPTCL. 6. Progressed on, refractory to, or intolerant to >=1 prior standard systemic therapy per investigator; with protocol-specific requirements (e.g., CD30-targeted therapy in CD30+ ALCL when standard/available unless contraindicated; asparaginase-containing prior therapy for NK/TCL unless allergic). Participants should be transplant-ineligible (autologous or allogeneic) at entry. 7. Adequate hematopoietic and organ function: - ANC >=1.5 x 10^9/L (>=1.0 x 10^9/L with baseline marrow involvement) without G-CSF within 7 days, - Platelets >=100 x 10^9/L (>=50 x 10^9/L with baseline marrow involvement) without G-CSF/transfusion within 7 days, - Hemoglobin >=8 g/dL without transfusion/erythropoietin within 7 days, - Total bilirubin <=1.5 x ULN (<=3 x ULN with Gilbert syndrome or baseline liver involvement), - ALT/AST <=2.5 x ULN, - GGT <=2.5 x ULN, - Creatinine <=1.5 x ULN or CrCl >=50 mL/min (Cockcroft-Gault or 24-hour urine method). 8. LVEF >=50% by MUGA or ECHO. 9. Ability and willingness to comply with study and follow-up. 10. Male reproductive requirements: protocol-defined contraception and no sperm donation for specified post-treatment windows depending on assigned treatment in Arm 2. 11. Female reproductive requirements: protocol-defined contraception, non-breastfeeding status, negative pre-dose pregnancy test for women of childbearing potential, and menopause/sterility criteria or effective contraception adherence.

Exclusion Criteria

Recent prohibited anti-cancer or investigational treatments, prior JAK/STAT inhibitor exposure, unresolved significant toxicities, CNS/meningeal lymphoma, severe pulmonary impairment/ILD, active serious infection (incl TB/HIV/HBV/HCV per protocol), major cardiac/QTc or thrombotic risk, significant uncontrolled comorbidity, pregnancy/lactation.

Participants are excluded if any of the following apply: 1. Prohibited treatment history within protocol windows, including recent investigational products, cytotoxic chemotherapy washout failures, excessive recent corticosteroids, major surgery/trauma, recent antibody/radiotherapy/immunoconjugates, recent anti-cancer immunotherapy, recent live vaccines, disallowed anticoagulants/antiplatelets/vitamin K antagonists, and strong CYP3A modulators/herbs/supplements not stopped per protocol. 2. Prior use of JAK or STAT3 inhibitors during prior PTCL treatment; or prior use of all four Arm 2 drugs. 3. Any unresolved >Grade 2 drug-related AEs before first study dose. 4. CNS and/or meningeal lymphoma involvement. 5. Significant pulmonary dysfunction (FEV1 and DLCO <60% predicted), prior non-infectious pneumonitis/drug-induced ILD/radiation pneumonitis needing steroids, or evidence of active clinically significant ILD. 6. Diseases/conditions requiring immunosuppressants, similar biologics, or NSAIDs as defined by protocol. 7. Active infection within 30 days, including protocol-defined TB/HIV/HBV/HCV and other serious infections requiring systemic treatment; protocol virology thresholds apply. 8. Significant cardiac abnormalities (e.g., NYHA >II CHF, significant valvular/cardiomyopathic disease, important ECG conduction/rhythm abnormalities, recent MI/unstable angina, heart transplant history, QTcF >480 ms, high-risk QT prolongation settings, prior/current thrombotic disease). 9. Other malignancy within 5 years except protocol-allowed low-risk/cured exceptions. 10. Refractory nausea/vomiting, significant GI disease or prior GI surgery likely to impair absorption. 11. Lactating women. 12. Hypersensitivity to study drug substance or chemical analogs. 13. Severe or poorly controlled systemic disease (e.g., uncontrolled hypertension) per investigator judgment. 14. Other factors likely to compromise compliance (mental/family/social/geographic issues). 15. Sponsor/site staff involved in trial planning or execution.

Enrollment

Progress3 / 4

Contact Information

Principal Investigator

陳彩雲

Study Nurse

李佳玲

Contact Tel

4620