Clinical trial · Interventional
Anti-PD-1 Antibody Combined With Pegaspargase in the Treatment of Advanced Stage NK/T-cell Lymphoma
The Efficacy and Safety of Anti-PD-1 Antibody in Combination With Pegaspargase in the Treatment of Newly Diagnosed, Stage III to IV Extranodal Natural Killer/T-Cell Lymphoma, Nasal Type
NCT04096690CI-TRIAL-00043952unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This open-label, single arm study will evaluate the efficacy and safety of anti-PD-1 antibody in combination with pegaspargase in treatment of newly diagnosed advanced stage NK/T-cell lymphoma.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Nasal Type Extranodal NK/T-Cell Lymphoma | Nasal Type Extranodal NK/T-Cell Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Anti-PD-1 monoclonal antibody | Drug | Anti-PD1 Monoclonal Antibody | ALIAS |
| Pegaspargase | Drug | Pegaspargase | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Anti-PD-1 antibody plus pegaspargase
- description
- Participants will receive induction treatment for six cycles of Anti-PD-1 antibody plus pegaspargase (21-day cycle) and Anti-PD-1 antibody monotherapy maintenance treatment for about 2 years (21-cycle)
- interventionNames
- Drug: Pegaspargase
- Drug: Anti-PD-1 monoclonal antibody
Primary outcomes (1)
- measure
- Complete response rate
- timeFrame
- At the end of Cycle 6 (each cycle is 21 days)
- description
- Percentage of participants with complete response was determined on the basis of investigator assessments according to 2014 Lugano criteria and 2016 Refinement of the Lugano Classification lymphoma response criteria in the era of immunomodulatory therapy.
Secondary outcomes (8)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Pathologically confirmed NK/T cell lymphoma based on 2016 WHO classification * Treatment naive * Age \> 18 years * Advanced stage * Must has measurable lesion in CT or PET-CT prior to treatment * ECOG 0,1,2 * Informed consented Exclusion Criteria: * Aggressive NK/T-cell leukemia * Has accepted PD-1,PD-L1 or PD-L2 antibody before * Has accepted autologous Stem cell transplantation before * History of malignancy except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix 3 years prior to study treatment * Uncontrollable cardio-cerebral vascular, coagulative, autoimmune, serious infectious disease * Primary CNS lymphoma * Lab at enrollment (Unless caused by lymphoma): Neutrophile\<1.5\*10\^9/L ;Platelet\<50\*10\^9/L; ALT or AST \>3\*ULN; Creatinine\>2\*ULN * Other uncontrollable medical condition that may that may interfere the participation of the study * Not able to comply to the protocol for mental or other unknown reasons Pregnant or lactation * HIV infection * HBV-DNA or HCV-RNA positive * Diagnosed immunodeficiency or received systemic corticoid therapy 2 weeks prior to first dose. * Received attenuated live vaccine 4 weeks prior to first dose.
References
Publications (0)
Data not yet available
No reference posted for this study.