Status:
UNKNOWN
Anti-PD-1 Antibody Combined With Pegaspargase in the Treatment of Advanced Stage NK/T-cell Lymphoma
Lead Sponsor:
Ruijin Hospital
Conditions:
Nasal Type Extranodal NK/T-Cell Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 ENKT...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 10 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2022
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT04096690
Start Date
September 10 2019
End Date
December 1 2022
Last Update
March 11 2020
Active Locations (1)
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1
Ruijin hospital
Shanghai, Shanghai Municipality, China, 200025