Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:01 AM
Ignite Modification Date:
2025-12-25 @ 1:01 AM
NCT ID:
NCT05833893
Eligibility Criteria:
Inclusion Criteria:
* Age≥14 years, male or female;
* Pathologically confirmed newly diagnosed NK/T cell lymphoma according to WHO classification criteria 2016;
* At least one measurable lesion, defined as bidimensionally measurable, intranodal lesion \> 1.5 cm in short axis and extranodal lesion \> 1.0 cm in short axis;
* ECOG score 0\~2;
* Clinical stage III\~IV;
* Normal major organ function, meeting the following definitions: Hematology: WBC ≥ 3.5 x 10 9/L, PLT ≥ 75 x 10 9/L, Hb ≥ 80 g/L; Liver and kidney function: AST and ALT ≤ 3.0 ULN; TBIL ≤ 2.0 mg/dL; CCr ≥ 60 mL/min; liver and kidney function impairment caused by tumor compression is not limited by this; Fibrinogen: normal at first cycle
* Expected survival \> 6 months
* Agree to use effective contraception;
* Understand and voluntarily sign written informed consent
Exclusion Criteria:
* Prior allogeneic HCT (allo-HCT)
* Active autoimmune disease
* Primary central nervous system lymphoma;
* Patients with infection which requiring treatment. Could be re-enrollment after infection control;
* Known history of human immunodeficiency virus (HIV) infection
* Known hypersensitivity to the study drug or any of its excipients;
* Presence of other active malignancy requiring treatment that could interfere with this study;
* Patients with other conditions not suitable for enrollment as judged by the investigator.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
14 Years
Study:
NCT05833893
Study Brief:
Protocol Section:
NCT05833893