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Phase II clinical study of PIC regimen, a combination of pegaspase, PD-1 monoclonal antibody, and Chidamide, for treating newly diagnosed advanced or relapsed / refractory natural killer / T-cell lymphoma: a prospective, single-arm study in a single center

Phase II clinical study of PIC regimen, a combination of pegaspase, PD-1 monoclonal antibody, and Chidamide, for treating newly diagnosed advanced or relapsed / refractory natural killer / T-cell lymphoma: a prospective, single-arm study in a single center

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100047130
Enrollment
Unknown
Registered
2021-06-08
Start date
2021-06-02
Completion date
Unknown
Last updated
2022-01-24

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

Conditions

Extranodal NK / T-cell lymphoma, nasal type

Interventions

treatment group:treated with PIC regimen

Sponsors

Department of Hematology, Beijing Tongren Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1.Diagnosed as ENKTL by histopathology; 2.The newly treated patients are in stage III-IV (Ann-Arbor staging system), or patients who have been relapsed and refractory after receiving any treatment for ENKTL; 3.There are evaluable lesions (CT, PET-CT or MRI evaluation, or skin lesions that can be evaluated by the naked eye); 4.Estimated survival time >= 3 months; 5.Aged 18 to 75 years; 6.The performance status (PS) is between 0-2 points of the ECOG score; 7.After the patient is enrolled in the trial, he cannot accept other drugs that may have a therapeutic effect on ENKTL; 8.White blood cell count >=3x10^9/L, neutrophil count >= 1.5x10^9/L, platelet count >= 75x10^9/L; 9.Serum creatinine = 50mL/min; 10.ALT, AST = 1.0g/L; 12.Sign informed consent.

Exclusion criteria

Exclusion criteria: 1.Existence of symptomatic CNS involvement, past or present with other malignant tumors; 2.The general condition of the patient is very poor, and the PS score is greater than 2 points; 3.Women who are pregnant or breastfeeding; 4.The patient (male or female) is likely to have children but is unwilling or fails to take effective contraceptive measures; 5.Known allergies to test drugs or any excipient components of these products; 6.Active infection (determined by the investigator); 7.According to the judgment of the investigator, there are accompanying diseases that seriously endanger the safety of the patient or affect the completion of the study; 8.Have a clear history of neurological or psychiatric disorders, including epilepsy or dementia.

Design outcomes

Primary

MeasureTime frame
Complete response rate;

Secondary

MeasureTime frame
Overall response rate;Progression-free survival at 1 year;Overall survival at 1 year;Adverse events;

Countries

China

Contacts

Public ContactWang Liang

Department of Hematology, Beijing Tongren Hospital, Capital Medical University

wangliangtrhos@126.com+86 15001108693

Outcome results

None listed

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