Treatment of Relapsed or Refractory Natural Killer/T Cell Lymphoma

Natural Killer/T-Cell Lymphoma, Nasal and Nasal-Type Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03107962
• Other study ID #: hnslblzlzx2017
• Status: Recruiting
• Phase: Phase 2
• First received: March 20, 2017
• Last updated: April 4, 2017
• Start date: February 19, 2017
• Est. completion date: December 2018

Study information

• Verified date: April 2017
• Source: Zhengzhou University
• Contact: Mingzhi Zhang, Pro,Dr
• Phone: 13838565629
• Email: mingzhi_zhang[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, T-Cell
• Natural Killer/T-Cell Lymphoma, Nasal and Nasal-Type

Intervention

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.

Locations

Country	Name	City	State
China	Oncology Department of The First Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Mingzhi Zhang

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Progression-free survival	Progression-free survival	up to end of follow-up-phase (approximately 24 months)
Secondary	Overall survival	Overall survival	up to the date of death (approximately 3 years)
Secondary	Median survival time	Median survival time	2 years