Treatment of Relapsed or Refractory Natural Killer/T Cell Lymphoma

NCT ID: NCT03107962

Last Updated: 2017-04-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-19
• Study Completion Date: 2018-12-31

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

PD-1 Blocking Antibody

Pembrolizumab

Group Type: EXPERIMENTAL

Pembrolizumab (PD-1 Blocking Antibody)

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Pembrolizumab

Eligibility Criteria

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

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mingzhi Zhang

OTHER

Sponsor Role: lead

Responsible Party

Mingzhi Zhang

the director of oncology department of the first affiliated hospital

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Mingzhi Zhang, Pro,Dr

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital of Zhengzhou University

Locations

Oncology Department of The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Site Status: RECRUITING

Countries

China

Central Contacts

Mingzhi Zhang, Pro,Dr

Role: CONTACT

mingzhi_zhang@126.com

13838565629

Facility Contacts

Mingzhi Zhang, Pro,Dr

Role: primary

mingzhi_zhang@126.com

13838565629

Other Identifiers

hnslblzlzx2017

Identifier Type: -

Identifier Source: org_study_id