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Phase II study for Anti-PD1 therapy combined with GEMOX for relapse/refractory Nasal Natural Killer/T-Cell Lymphoma failure to Peg-ASP-based regimen: a prospective single-center clinical trial

Phase II study for Anti-PD1 therapy combined with GEMOX for relapse/refractory Nasal Natural Killer/T-Cell Lymphoma failure to Peg-ASP-based regimen: a prospective single-center clinical trial

Status
Recruiting
Phases
Phase 2
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1900022826
Enrollment
Unknown
Registered
2019-04-27
Start date
2019-05-01
Completion date
Unknown
Last updated
2019-04-30

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

1:Anti-PD1+GEMOX

Sponsors

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients must meet the following criteria for study entry: 1. Aged 18 to 75 years, ECOG performance status of 0, 1, or 2, Life expectancy of >12 weeks; 2. All patents are diagnosed as R/R Natural Killer/T-Cell Lymphoma failure to Peg-ASP-based regimen by pathology and history; 3. Adequate hematologic and hepatic-renal function: Hemoglobin >=9 g/dl, Absolute neutrophil count >=1.5*10^9/L, Platelet count >=100*10^9/L, ALT 1.5cm in its largest dimension on CT scan; 5. Adequate cardiopulmonary function, no other serious disease; 6. The Pregnancy test of blood or urine is negative for women of reproductive potential. All patients agree to use adequate methods of contraception during the treatment period and until >= 12 months after the last chemotherapy; 7. Ability and willingness to comply with the study protocol.

Exclusion criteria

Exclusion criteria: 1)NK cell leukemia; 2) accompanied by hemophagocytic syndrome; 3) central nervous system involvement or central nervous system NK/T cell lymphoma; 4) patients who have previously received allogeneic organ transplantation or need long-term application of anti-rejection drugs; 5) participating in other clinical studies, or less than 4 weeks after the last treatment; 6) autologous stem cell transplantation was performed within 90 days before the study started; Or had major surgery within 4 weeks; Or receive radiotherapy within the previous 3 months; 7) received live vaccine within 4 weeks before the study; 8) patients with previous interstitial lung disease; 9) patients who have received other checkpoint inhibitors, such as PD1 monoclonal antibody, pd-l1 monoclonal antibody and CTLA4 monoclonal antibody; 10) patients with drug allergy or metabolic disorder to the drugs in this program; 11) those who refuse to adopt reliable contraceptive methods during pregnancy and lactation or the right age; 12) any uncontrollable medical diseases (including uncontrolled diabetes, severe heart, lung, liver and kidney insufficiency); 13) patients who need systemic glucocorticoid therapy or other immunosuppressive therapy for other diseases within 2 weeks before treatment; 14) accompanied by active infection, such as tuberculosis; 15) contraindications to chemotherapy; 16) previous medical history of other malignant tumors; 17) mental disorder, incapacity or limited capacity.

Design outcomes

Primary

MeasureTime frame
CR;PR;SD;

Secondary

MeasureTime frame
OR;OS;PFS;

Countries

China

Contacts

Public ContactLiling Zhang

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

lily1228@sina.com+86 15871725926

Outcome results

None listed

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