Treatment of Relapsed or Refractory Natural Killer/T Cell Lymphoma

Mingzhi Zhang

Status and phase: Unknown; Phase 2

Conditions: Natural Killer/T-Cell Lymphoma, Nasal and Nasal-Type

Treatments: Drug: Pembrolizumab (PD-1 Blocking Antibody)

Study type: Interventional

Funder types: Other

Identifiers

NCT03107962

hnslblzlzx2017

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 14 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

PD-1 Blocking Antibody

Experimental group

Description:

Pembrolizumab

Treatment:

Drug: Pembrolizumab (PD-1 Blocking Antibody)