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
Overview
- Phase
- Phase 2
- Intervention
- Pegaspargase
- Conditions
- Nasal Type Extranodal NK/T-Cell Lymphoma
- Sponsor
- Ruijin Hospital
- Enrollment
- 22
- Locations
- 1
- Primary Endpoint
- Complete response rate
- Last Updated
- 6 years ago
Overview
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.
Investigators
Zhao Weili
First Deputy Director，Hematology Department
Ruijin Hospital
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
Arms & Interventions
Anti-PD-1 antibody plus pegaspargase
Participants will receive induction treatment for six cycles of Anti-PD-1 antibody plus pegaspargase (21-day cycle) and Anti-PD-1 antibody monotherapy maintenance treatment for about 2 years (21-cycle)
Intervention: Pegaspargase
Anti-PD-1 antibody plus pegaspargase
Participants will receive induction treatment for six cycles of Anti-PD-1 antibody plus pegaspargase (21-day cycle) and Anti-PD-1 antibody monotherapy maintenance treatment for about 2 years (21-cycle)
Intervention: Anti-PD-1 monoclonal antibody
Outcomes
Primary Outcomes
Complete response rate
Time Frame: At the end of Cycle 6 (each cycle is 21 days)
Percentage of participants with complete response was determined on the basis of investigator assessments according to 2014 Lugano criteria and 2016 Refinement of the Lugano Classification lymphoma response criteria in the era of immunomodulatory therapy.
Secondary Outcomes
- EBV-DNA load change(End of induction treatment (approximately 1 year))
- Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0(Baseline up to data cut-off (up to approximately 4 years))
- Overall response rate(At the end of Cycle 6 (each cycle is 21 days))
- Overall survival(Baseline up to data cut-off (up to approximately 4 years))
- Duration of response(Baseline up to data cut-off (up to approximately 4 years))
- Progression free survival(Baseline up to data cut-off (up to approximately 4 years))
- Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Core 30 (EORTC QLQ-C30) Domain Scores(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))
- Treatment related mortality(Baseline up to data cut-off (up to approximately 4 years))