Treatment of Relapsed or Refractory Natural Killer/T Cell Lymphoma

Phase 2

• Conditions: Natural Killer/T-Cell Lymphoma, Nasal and Nasal-Type
• Interventions: Drug: Pembrolizumab (PD-1 Blocking Antibody)

• Registration Number: NCT03107962
• Lead Sponsor: Mingzhi Zhang

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.

Study Timeline

• Study Start: 2017-02-19
• Study First Submitted: 2017-03-20
• Status Verified: 2017-04
• Study First Submitted QC: 2017-04-04
• Last Update Submitted: 2017-04-04
• Study First Posted: 2017-04-11
• Last Update Posted: 2017-04-11
• Primary Completion: 2018-12
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PD-1 Blocking Antibody	Pembrolizumab (PD-1 Blocking Antibody)	Pembrolizumab

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Median survival time	2 years	Median survival time
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

Trial Locations

Locations (1)

Oncology Department of The First Affiliated Hospital of Zhengzhou University; 🇨🇳 Zhengzhou, Henan, China