Treatment of Relapsed or Refractory Natural Killer/T Cell Lymphoma

NCT03107962 | Unknown Phase 2 FDA Drug

• 1 other identifier: hnslblzlzx2017
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

NK/T cell lymphoma; immunotherapy; clinical trial; RR; PFS; OS

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Progression-free survival

  up to end of follow-up-phase (approximately 24 months)

• Overall survival

  up to the date of death (approximately 3 years)

• Median survival time

  2 years

Study Arms (1)

PD-1 Blocking Antibody

EXPERIMENTAL

Pembrolizumab

Drug: Pembrolizumab (PD-1 Blocking Antibody)

Interventions

Pembrolizumab (PD-1 Blocking Antibody) 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.

Also known as: Pembrolizumab

PD-1 Blocking Antibody

Eligibility Criteria

• Age: 14 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mingzhi Zhang: lead

Study Sites (1)

Oncology Department of The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450052, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, Extranodal NK-T-Cell

Interventions

pembrolizumab

Condition Hierarchy (Ancestors)

Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Mingzhi Zhang, Pro,Dr

  The First Affiliated Hospital of Zhengzhou University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mingzhi Zhang, Pro,Dr

CONTACT

13838565629; mingzhi_zhang@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: the director of oncology department of the first affiliated hospital

Study Record Dates

• First Submitted: March 20, 2017
• First Posted: April 11, 2017
• Study Start: February 19, 2017
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: April 11, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)