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Efficacy and safety of DAPT regimen (dexamethasone, azacitidine, pegaspargase, tislelizumab) for NK/T cell lymphoma

Efficacy and safety of DAPT regimen (dexamethasone, azacitidine, pegaspargase, tislelizumab) for NK/T cell lymphoma

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500109853
Enrollment
Unknown
Registered
2025-09-25
Start date
2024-07-30
Completion date
Unknown
Last updated
2025-09-29

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

DAPT group:DAPT regimen

Sponsors

Beijing Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1.Age range from 18 to 70 years old; ECOG score 0-2 points; 2.NK/T cell lymphoma patients confirmed by pathological histology; 3.Advanced stage, non upper respiratory and digestive tract origin, or relaplsed/refractory disease; 4.Hemoglobin >= 90g/L, absolute neutrophil count >= 1.5 × 10^9/L, platelets >= 75 × 10^9/L, ALT <= 2 times the upper limit of normal, serum creatinine <= 1.5 times the upper limit of normal (enrollment can be adimited if the above indicators are abnormal due to primary disease evaluated by clinical doctors); 5.At least one measurable lesion; 6.There are no other serious diseases that conflict with this plan, and the cardiovascular and pulmonary functions are basically normal; 7.Negative urine or blood pregnancy test in those female patients of childbearing age; 8.Expected survival time of more than 3 months; 9.There are no other anti-tumor concomitant treatments (including traditional Chinese medicine, immunotherapy, and biological therapy for anti-tumor), but bisphosphate anti bone metastasis therapy and other symptomatic treatments can be applied; 10.Understand the situation of this study and sign an informed consent form.

Exclusion criteria

Exclusion criteria: 1.Pathology failed to diagnose NK/T cell lymphoma; 2.Early stage patients with upper respiratory and digestive tract origin; 3.Individuals with drug allergies or metabolic disorders to the drugs in this plan; 4.Any uncontrollable medical disease (including uncontrolled diabetes, severe heart, lung, liver and kidney dysfunction); 5.Accompanied by severe infections (excluding patients who are HBsAg or anti HBc positive but also taking entecavir, tenofovir, and other drugs; patients who are HCV RNA positive but taking direct anti HCV drugs); 6.Individuals with primary or secondary central nervous system tumor invasion; 7.There are contraindications to chemotherapy or radiotherapy; 8.Previously suffering from other malignant tumors (excluding malignant tumors with no activity for at least 2 years prior to enrollment; non melanoma skin cancer or malignant freckle like nevi with sufficient treatment and no evidence of disease recurrence; primary cancer with sufficient treatment and no evidence of disease recurrence); 9.Existence of peripheral nervous system disorders or mental disorders; 10.Individuals without legal capacity or those whose medical or ethical reasons affect the continuation of research; 11.Simultaneously participating in other clinical researchers; 12.Individuals who use anti-tumor drugs outside of the research protocol; 13.Researchers believe that participants are not suitable for this experiment.

Design outcomes

Primary

MeasureTime frame
Overall response rate;

Secondary

MeasureTime frame
Complete remission rate;Progression-Free-Surviva;Overall survival;

Countries

China

Contacts

Public ContactWeiping Liu

Beijing Cancer Hospital

dreaming2217@126.com+86 10 88196109

Outcome results

None listed

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