Back to results

Treatment of Relapsed or Refractory Natural Killer/T Cell Lymphoma

Primary Purpose

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

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Pembrolizumab (PD-1 Blocking Antibody)

About this trial

This is an interventional treatment trial for Natural Killer/T-Cell Lymphoma, Nasal and Nasal-Type focused on measuring NK/T cell lymphoma, immunotherapy, clinical trial, RR, PFS, OS

Eligibility Criteria

14 Years - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Oncology Department of The First Affiliated Hospital of Zhengzhou UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

PD-1 Blocking Antibody

Arm Description

Pembrolizumab

Outcomes

Primary Outcome Measures

Response rate

21 days (3 weeks) for one cycle, Efficacy was evaluated every two cycles.

Secondary Outcome Measures

Progression-free survival

Overall survival

Median survival time

Full Information

NCT ID

NCT03107962

First Posted

March 20, 2017

Last Updated

April 4, 2017

Sponsor

Mingzhi Zhang

1. Study Identification

Unique Protocol Identification Number

NCT03107962

Brief Title

Treatment of Relapsed or Refractory Natural Killer/T Cell Lymphoma

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2017

Overall Recruitment Status

Unknown status

Study Start Date

February 19, 2017 (Actual)

Primary Completion Date

December 2018 (Anticipated)

Study Completion Date

December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Mingzhi Zhang

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

PD-1 Blocking Antibody

Arm Type

Experimental

Arm Description

Pembrolizumab

Intervention Type

Drug

Intervention Name(s)

Pembrolizumab (PD-1 Blocking Antibody)

Other Intervention Name(s)

Pembrolizumab

Intervention Description

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.

Primary Outcome Measure Information:

Title

Response rate

Description

21 days (3 weeks) for one cycle, Efficacy was evaluated every two cycles.

Time Frame

every 6 weeks, up to completion of treatment (approximately 18 weeks, unless the disease progresses or patients cannot tolerate the drug)

Secondary Outcome Measure Information:

Title

Progression-free survival

Description

Progression-free survival

Time Frame

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

Title

Overall survival

Description

Overall survival

Time Frame

up to the date of death (approximately 3 years)

Title

Median survival time

Description

Median survival time

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

14 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Mingzhi Zhang, Pro,Dr

Phone

13838565629

mingzhi_zhang@126.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mingzhi Zhang, Pro,Dr

Organizational Affiliation

The First Affiliated Hospital of Zhengzhou University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Oncology Department of The First Affiliated Hospital of Zhengzhou University

City

Zhengzhou

State/Province

Henan

ZIP/Postal Code

450052

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Mingzhi Zhang, Pro,Dr

Phone

13838565629

mingzhi_zhang@126.com

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Treatment of Relapsed or Refractory Natural Killer/T Cell Lymphoma

We'll reach out to this number within 24 hrs