Clinical trial · Interventional
Treatment of Relapsed or Refractory Natural Killer/T Cell Lymphoma
PD-1 Blockade With Pembrolizumab in Relapsed or Refractory Natural Killer/T Cell Lymphoma
NCT03107962CI-TRIAL-00026903unknownPhase 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)
The purpose of this study is to evaluate the efficacy and safety of PD-1 blockade pembrolizumab for patients with relapsed or refractory Natural Killer(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 |
|---|---|---|---|
| Natural Killer/T-Cell Lymphoma, Nasal and Nasal-Type | Nasal Type Extranodal NK/T-Cell Lymphoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pembrolizumab (PD-1 Blocking Antibody) | Drug | Pembrolizumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- PD-1 Blocking Antibody
- description
- Pembrolizumab
- interventionNames
- Drug: Pembrolizumab (PD-1 Blocking Antibody)
Primary outcomes (1)
- measure
- Response rate
- timeFrame
- every 6 weeks, up to completion of treatment (approximately 18 weeks, unless the disease progresses or patients cannot tolerate the drug)
- description
- 21 days (3 weeks) for one cycle, Efficacy was evaluated every two cycles.
Secondary outcomes (3)
- measure
- Progression-free survival
- timeFrame
- up to end of follow-up-phase (approximately 24 months)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 14 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Age range 14-70 years old; ECOG performance status 0-2; Estimated survival time \> 3 months * Histological confirmed evidence of relapsed or refractory NK/T cell lymphoma * Before enrollment, representative formalin-fixed paraffin-embedded tumor samples (or 15 tissue sections at least) and related pathological reports are needed * Previous treatment with at least one chemotherapy regimen * At least one measurable lesion * None of other serious diseases, cardiopulmonary function is normal * Pregnancy test of women at reproductive age must be negative * Patients could be followed up * None of other relative treatments including the traditional Chinese medicine, immunotherapy, biotherapy except anti-bone metastasis therapy and other symptomatic treatments. * volunteers who signed informed consent. * No anti-PD1 antibody contraindication (All of the following tests are required to be finished within 14 days prior to the first research): 2.5×109/L\<WBC\<15×109/L, hemoglobin ≥ 90 g/L, neutrophil≥ 1.5×109/L, lymphocyte≥0.5×109/L, platelet ≥ 100×109/L, serum albumin≥2.5g/dL, ALT and AST ≤ 2×ULN, serum bilirubin≤ 1.5×ULN, serum creatine ≤ 1.5×ULN, Serum Albumin ≥ 30g/L, serum plasminogen is normal, creatinine clearance rate≥30 mL/min, INR≤1.5×ULN, APTT≤1.5×ULN Exclusion Criteria: * Disagreement on blood sample collection * Patients allergic of chimeric or humanized antibody * Pregnant or lactating women * Serious medical illness likely to interfere with participation * Serious infection * Primitive or secondary tumors of central nervous system * The evidence of CNS metastasis * History of peripheral nervous disorder or dysphrenia * History of active autoimmune disease and a concomitant second cancer * patients participating in other clinical trials * patients taking other antitumor drugs * patients estimated to be unsuitable by investigator
References
Publications (0)
Data not yet available
No reference posted for this study.