Clinical trial NCT04096690: Anti-PD-1 Antibody Combined With Pegaspargase in the Treatment of Advanced Stage NK/T-cell Lymphoma
Official title: The Efficacy and Safety of Anti-PD-1 Antibody in Combination With Pegaspargase in the Treatment of Newly Diagnosed, Stage III to IV Extranodal Natural Killer/T-Cell Lymphoma, Nasal Type
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Nasal Type Extranodal NK/T-Cell Lymphoma
Keywords: Anti-PD-1 antibody
Nasal Type Extranodal NK/T-Cell Lymphoma
Complete response rate
Safety
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2019-09-20
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This open-label, single arm study will evaluate the efficacy and safety of anti-PD-1 antibody in combination with pegaspargase in treatment of newly diagnosed advanced stage NK/T-cell lymphoma.

Detailed description: Extranodal natural killer (NK)/T-cell lymphoma (ENKTL), nasal type, is a distinct and heterogeneous histopathologic subtype of non-Hodgkin lymphoma (NHL), accounting for 5%\~10%. The frequency of ENKTL among NHL patients is significantly higher in Asia than in Western countries, with poor prognosis. L-asparaginase-based chemotherapy has improved the survival for these patients with advanced stage. However, there is no standard of care for those patients with advanced stage. Anti-PD-1 antibody has been proven its efficacy in relapsed or refractory NK/T cell lymphoma. This open-label, single arm study will evaluate the efficacy and safety of PD-1 antibody in combination with pegaspargase in treatment of newly diagnosed advanced stage NK/T-cell lymphoma.

Eligibility criteria: Inclusion Criteria:

* Pathologically confirmed NK/T cell lymphoma based on 2016 WHO classification
* Treatment naive
* Age \> 18 years
* Advanced stage
* Must has measurable lesion in CT or PET-CT prior to treatment
* ECOG 0,1,2
* Informed consented

Exclusion Criteria:

* Aggressive NK/T-cell leukemia
* Has accepted PD-1,PD-L1 or PD-L2 antibody before
* Has accepted autologous Stem cell transplantation before
* History of malignancy except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix 3 years prior to study treatment
* Uncontrollable cardio-cerebral vascular, coagulative, autoimmune, serious infectious disease
* Primary CNS lymphoma
* Lab at enrollment (Unless caused by lymphoma): Neutrophile\<1.5\*10\^9/L ;Platelet\<50\*10\^9/L; ALT or AST \>3\*ULN; Creatinine\>2\*ULN
* Other uncontrollable medical condition that may that may interfere the participation of the study
* Not able to comply to the protocol for mental or other unknown reasons Pregnant or lactation
* HIV infection
* HBV-DNA or HCV-RNA positive
* Diagnosed immunodeficiency or received systemic corticoid therapy 2 weeks prior to first dose.
* Received attenuated live vaccine 4 weeks prior to first dose.

Primary outcomes:
measure: Complete response rate
timeFrame: At the end of Cycle 6 (each cycle is 21 days)
Secondary outcomes:
measure: Overall response rate
timeFrame: At the end of Cycle 6 (each cycle is 21 days)
measure: Progression free survival
timeFrame: Baseline up to data cut-off (up to approximately 4 years)
measure: Overall survival
timeFrame: Baseline up to data cut-off (up to approximately 4 years)
measure: Duration of response
timeFrame: Baseline up to data cut-off (up to approximately 4 years)
measure: EBV-DNA load change
timeFrame: End of induction treatment (approximately 1 year)
measure: Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0
timeFrame: Baseline up to data cut-off (up to approximately 4 years)
measure: Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Core 30 (EORTC QLQ-C30) Domain Scores
timeFrame: Baseline (pre-dose [Hour 0] on Cycle1 Day1), Cycle3 Day 1, end of treatment (up to Month 6), every 3 months 1st year, every 6 months 2nd year, and 12 months thereafter up to data cut-off, up to approximately 4 years (cycle length = 21 days)
measure: Treatment related mortality
timeFrame: Baseline up to data cut-off (up to approximately 4 years)
Other outcomes:
measure: Circulating free Deoxyribonucleic Acid (cfDNA) monitoring
timeFrame: Baseline up to data cut-off (up to approximately 4 years)
Locations:
city: Shanghai
country: China
facility: Ruijin hospital
state: Shanghai
Study officials:
References: