Clinical trial NCT03107962: 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
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Natural Killer/T-Cell Lymphoma, Nasal and Nasal-Type
Keywords: NK/T cell lymphoma
immunotherapy
clinical trial
RR
PFS
OS
Lead sponsor: Zhengzhou University
Sponsor class: OTHER
First posted: 2017-04-11
Enrollment: 20
Sex: ALL
Minimum age (years): 14
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Response rate
timeFrame: every 6 weeks, up to completion of treatment (approximately 18 weeks, unless the disease progresses or patients cannot tolerate the drug)
Secondary outcomes:
measure: Progression-free survival
timeFrame: up to end of follow-up-phase (approximately 24 months)
measure: Overall survival
timeFrame: up to the date of death (approximately 3 years)
measure: Median survival time
timeFrame: 2 years
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: Oncology Department of The First Affiliated Hospital of Zhengzhou University
state: Henan
Study officials:
affiliation: The First Affiliated Hospital of Zhengzhou University
name: Mingzhi Zhang, Pro,Dr
role: PRINCIPAL_INVESTIGATOR
References: