Natural Killer/T-Cell Lymphoma, Nasal and Nasal-Type
Conditions
Keywords
NK/T cell lymphoma, immunotherapy, clinical trial, RR, PFS, OS
Brief summary
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.
Detailed description
Patients with relapsed or refractory NK/T cell lymphoma usually have a bad prognosis. These patients cannot be treated successfully with the conventional chemotherapy. The investigators have been proceeding this trial to evaluate the efficacy and safety of the immune checkpoint inhibitor PD-1 blockade, pembrolizumab in the patients with relapsed or refractory NK/T cell lymphoma.
Interventions
pembrolizumab 2mg/kg, ivgtt (intravenously guttae), d1. Every three weeks for one cycle and two cycles are required at least. Efficacy and safety were evaluated every two cycles.
Sponsors
Mingzhi Zhang
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
14 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Response rate | every 6 weeks, up to completion of treatment (approximately 18 weeks, unless the disease progresses or patients cannot tolerate the drug) | 21 days (3 weeks) for one cycle, Efficacy was evaluated every two cycles. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival | up to end of follow-up-phase (approximately 24 months) | Progression-free survival |
| Overall survival | up to the date of death (approximately 3 years) | Overall survival |
| Median survival time | 2 years | Median survival time |
Countries
China
Contacts
Primary ContactMingzhi Zhang, Pro,Dr
Outcome results
None listed