Nasal Type Extranodal NK/T-Cell Lymphoma Clinical Trial
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
Verified date | March 2020 |
Source | Ruijin Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Recruiting |
Enrollment | 22 |
Est. completion date | December 2022 |
Est. primary completion date | December 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
China | Ruijin hospital | Shanghai | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Ruijin Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Circulating free Deoxyribonucleic Acid (cfDNA) monitoring | CfDNA in peripheral blood assessed by local lab | Baseline up to data cut-off (up to approximately 4 years) | |
Primary | Complete response rate | 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. | At the end of Cycle 6 (each cycle is 21 days) | |
Secondary | Overall response rate | Percentage of participants with overall 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. | At the end of Cycle 6 (each cycle is 21 days) | |
Secondary | Progression free survival | Progression-free survival was defined as the time from the date of diagnosis until the date of the first documented day of disease progression or relapse, using 2014 Lugano criteria2016 Refinement of the Lugano Classification lymphoma response criteria in the era of immunomodulatory therapy, or death from any cause, whichever occurred first. | Baseline up to data cut-off (up to approximately 4 years) | |
Secondary | Overall survival | Overall survival in the overall study population was defined as the time from the date of diagnosis to the date of death from any cause. Reported is the percentage of participants with event. | Baseline up to data cut-off (up to approximately 4 years) | |
Secondary | Duration of response | Time from first occurrence of documented CR or PR to disease progression/relapse, or death from any cause for participants with a response of CR or PR. Tumor assessments were performed with PET-CT. | Baseline up to data cut-off (up to approximately 4 years) | |
Secondary | EBV-DNA load change | EBV-DNA load at each cycle for comparison | End of induction treatment (approximately 1 year) | |
Secondary | Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0 | An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. | Baseline up to data cut-off (up to approximately 4 years) | |
Secondary | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Core 30 (EORTC QLQ-C30) Domain Scores | The EORTC QLQ-C30 is a health-related quality of life questionnaire. A higher score indicates better quality of life, with changes of 5 to 10 points considered to be a minimally important difference to participants. | 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) | |
Secondary | Treatment related mortality | Percentage of death related with treatment on the basis of investigator assessments | Baseline up to data cut-off (up to approximately 4 years) |
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