Status:
UNKNOWN
Pegaspargase-COEP Chemotherapy Combined With Radiotherapy for Extra-nodal NK/T Cell Lymphoma
Lead Sponsor:
Peking University
Collaborating Sponsors:
Peking University Cancer Hospital & Institute
Peking University International Hospital
Conditions:
NK/T Cell Lymphoma Nos
Eligibility:
All Genders
14-80 years
Phase:
PHASE2
Brief Summary
The optimal first-line treatment for extra-nodal NK/T-cell lymphoma (ENKTL) has not been well-defined. This phase II study aimed to evaluate the efficacy and safety of pegaspargase, cyclophosphamide, ...
Eligibility Criteria
Inclusion
- patients with confirmed pathological diagnosis of ENKTL as defined by WHO criteria
- age 14-80 years
- no prior chemotherapy or radiotherapy
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- at least one measurable lesion
- adequate bone marrow function (i.e. hemoglobin ≥80 g/l, absolute neutrophil count ≥ 1.0 × 10\^9/L, platelets ≥ 100 ×10\^9/L), adequate renal function (i.e. serum creatinine ≤177 μmol/L), adequate hepatic function (e.g. total bilirubin ≤ two times the upper limit of normal, and ALT /AST ≤2.5 times the upper limit of normal)
- expected survival of more than three months
Exclusion
- invasion of lymphoma to central nervous system
- pre-existing coagulation disorder
- other concomitant neoplasms
- severe infection
- positive HIV antibody
- HBV DNA titer higher than 10\^4 copies /ml in HBsAg-positive patients post antiviral therapy
- pregnant or lactating women
- women of childbearing age unwilling to take contraceptive measures during the study period
Key Trial Info
Start Date :
October 20 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2025
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT04484506
Start Date
October 20 2011
End Date
December 30 2025
Last Update
July 23 2020
Active Locations (1)
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1
Peking University Cancer Hospital & Institute
Beijing, Beijing Municipality, China, 100142