Golidocitinib Combined With GemOx in RR PTCL

An Open-Label, Single-Arm Study to Evaluate the Safety and Efficacy of Golidocitinib Combined With GemOx in the Treatment of Relapsed or Refractory Peripheral T-Cell Lymphoma

NCT07279584•Ruijin Hospital

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Summary

The objective of this study is to evaluate the efficacy and safety of golidocitinib in combination with the GemOx regimen in r/r PTCL

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. fully understood and voluntarily signed the ICF for this study
•2. aged ≥ 18 years;
•3. patients with R/R PTCL who have received at least one prior systemic therapy.
•4. Patients must have at least one measurable lesion by computed tomography (CT)/magnetic resonance imaging (MRI) (longest diameter of lymph node lesions \> 1.5 cm or longest diameter of extranodal lesions \> 1 cm); evaluable lesions: PET-CT examination showed increased local uptake in lymph nodes or extranodal sites (higher than liver) and imaging characteristics consistent with lymphoma performance
•5. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2;
•6. Adequate bone marrow function, renal function, liver function: ANC ≥ 1.0 × 109/L, hemoglobin ≥ 8.0 g/dL, platelets ≥ 75 × 109/L Note: if the investigator believes that the patient 's above test values are below the lower limit of the protocol due to lymphoma invading the bone marrow, the patient can be enrolled after assessment.Creatinine clearance \> 40 mL/min, calculated by Cockcroft-Gault method: • serum total bilirubin ≤ 1.5 x upper limit of normal (ULN), except for unconjugated bilirubinemia in Gilbert 's syndrome; • ALP (in the absence of bone disease), ALT, and AST ≤ 3.0 × ULN (in the presence of liver metastases, ≤ 5 × ULN); • international normalized ratio (INR) ≤ 1.5 × ULN, or activated partial thromboplastin time (APTT) ≤ 1.5 × ULN;
•7. Current negative for human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV), or cytomegalovirus (CMV), and inactive if positive:
•* HBV infected patients with positive hepatitis B surface antigen (HbsAg) or hepatitis B core antibody (HbcAb)\] but negative results of HBV DNA polymerase chain reaction (PCR) test can be enrolled; these patients require continuous antiviral therapy after enrollment and HBV DNA PCR test is performed every cycle;
•* Patients with positive HCV serology but negative HCV RNA test may be enrolled;
•* CMV IgM antibody positive,However, patients who tested negative for CMV DNA could be enrolled;
+1 more criteria

Exclusion Criteria

•1. previously used drugs in the treatment regimen may affect the efficacy evaluation of this study (assessed by the investigator)
•2. previous bone marrow malignancies, including MDS, AML, MPN, etc.
•3. and have clinically significant abnormal test results as judged by the investigator;
•4. inability to be orally administered, previous surgical history or severe gastrointestinal diseases such as dysphagia, active gastric ulcer, etc., which the investigator believes may affect the absorption of the study drug;
•5. major surgery within 4 weeks before the first study drug administration (referring to grade 3 and 4 surgery as specified in the Measures for the Administration of Clinical Application of Medical Technology implemented on May 1, 2009);
•6. current clinically significant active cardiovascular disease, such as uncontrolled arrhythmia, congestive heart failure, any grade 3 or 4 heart disease defined by the New York Heart Association functional classification, or a history of myocardial infarction within 6 months after screening.Left ventricular ejection fraction \< 50% measured by echocardiography
•7. Venous thrombosis or pulmonary embolism within 3 months before study drug administration;
•8. History of stroke or intracranial hemorrhage within 6 months before the first study drug administration;
•9. Active infection requiring systemic treatment;
•10. History of inflammatory bowel disease (eg, Crohn 's disease or ulcerative colitis);
+5 more criteria

Key Dates

Start Date

December 20, 2025

Primary Completion Date

December 31, 2026

Completion Date

December 31, 2027

Last Updated

December 12, 2025

Enrollment

ESTIMATED participants

Conditions

Peripheral T-cell Lymphomas (PTCL)

Interventions

golidocitinib

DRUG

GEMOX

DRUG

Contacts

Weili Zhao

CONTACT

02164370045 zwl_trial@163.com

Shu Cheng

CONTACT

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 12, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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