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A prospective, multicenter, single-arm clinical study evaluating the efficacy and safety of Golidocitinib combined with P-Gemox in patients with newly diagnosed stage III/IV or non-upper respiratory/digestive extranodal NK/T cell lymphoma

A prospective, multicenter, single-arm clinical study evaluating the efficacy and safety of Golidocitinib combined with P-Gemox in patients with newly diagnosed stage III/IV or non-upper respiratory/digestive extranodal NK/T cell lymphoma

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400091612
Enrollment
Unknown
Registered
2024-10-31
Start date
2024-11-01
Completion date
Unknown
Last updated
2024-11-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

NK/T cell lymphoma

Interventions

study group:Golidocitinib 150mg QD pegaspargase 2500U/? (3750IU) D2 gemcitabine 1g/? D1,8 oxaliplatin

Sponsors

The first affiliated hospital Zhejiang University school of medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1) According to the fifth edition of WHO Classification of lymphohematopoietic system tumors, the patient was pathologically diagnosed as extranodal NK/T cell lymphoma; 2) Age 18-80; 3) Newly diagnosed extranodal NK/T cell lymphoma without receiving radiotherapy or chemotherapy; 4)Ann Arbor stage III-IV, or non-upper respiratory/digestive tract ENKTL; 5)PET-CT or CT/MRI shows at least one two-dimensional measurable lesion (maximum diameter > 1.5cm); 6) Women of childbearing age must be confirmed not to be pregnant through pregnancy tests, and are willing to take effective contraceptive measures during the test period and =12 months after the last dose of medication; Pregnant and lactating women cannot participate; All male subjects used contraception during the study period and =3 months after the last dose; 7) Can provide informed consent, can understand and comply with the study.

Exclusion criteria

Exclusion criteria: 1) Have a serious mental illness; 2)HIV infection; 3) severe renal dysfunction (glomerular filtration rate 20) 5) history of other active tumors 6) pregnant or lactating women 7) failure to understand or follow the study protocol.

Design outcomes

Primary

MeasureTime frame
Progression-free survival;safety;

Secondary

MeasureTime frame
overall response rate;complete remission rate;partial remission rate;overall survival;

Countries

China

Contacts

Public ContactHongyan Tong

The first affiliated hospital Zhejiang University school of medicine

tonghongyan@zju.edu.cn+86 571 8723 5560

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026