Treatment of Relapsed or Refractory Natural Killer/T Cell Lymphoma

PD-1 Blockade With Pembrolizumab in Relapsed or Refractory Natural Killer/T Cell Lymphoma

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.

Study Overview

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

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 Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Henan
    • Zhengzhou, Henan, China, 450052
      • Recruiting
      • Oncology Department of The First Affiliated Hospital of Zhengzhou University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 70 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PD-1 Blocking Antibody; Pembrolizumab	Drug: Pembrolizumab (PD-1 Blocking Antibody); 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.; Other Names: Pembrolizumab

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Response rate	21 days (3 weeks) for one cycle, Efficacy was evaluated every two cycles.	every 6 weeks, up to completion of treatment (approximately 18 weeks, unless the disease progresses or patients cannot tolerate the drug)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free survival	Progression-free survival	up to end of follow-up-phase (approximately 24 months)
Overall survival	Overall survival	up to the date of death (approximately 3 years)
Median survival time	Median survival time	2 years

Collaborators and Investigators

• Sponsor: Mingzhi Zhang
• Investigators: Principal Investigator: Mingzhi Zhang, Pro,Dr, the First Affiliated Hospital of Zhengzhou University

Study record dates

Study Major Dates

• Study Start (Actual): February 19, 2017
• Primary Completion (Anticipated): December 1, 2018
• Study Completion (Anticipated): December 1, 2018

Study Registration Dates

• First Submitted: March 20, 2017
• First Submitted That Met QC Criteria: April 4, 2017
• First Posted (Actual): April 11, 2017

Study Record Updates

• Last Update Posted (Actual): April 11, 2017
• Last Update Submitted That Met QC Criteria: April 4, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: immunotherapy; clinical trial; PFS; RR; OS; NK/T cell lymphoma
• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Lymphoma, T-Cell; Lymphoma, T-Cell, Peripheral; Physiological Effects of Drugs; Antineoplastic Agents; Immunologic Factors; Antineoplastic Agents, Immunological; Antibodies; Antibodies, Blocking; Pembrolizumab
• Other Study ID Numbers: hnslblzlzx2017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes