Pegaspargase-COEP Chemotherapy Combined With Radiotherapy for Extra-nodal NK/T Cell Lymphoma

Launched by PEKING UNIVERSITY · Jul 20, 2020

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for extra-nodal NK/T-cell lymphoma (ENKTL), a type of cancer that affects certain immune cells. The researchers want to see how well a combination of medications, including pegaspargase and a few others, works when used together with radiotherapy (a treatment that uses high-energy rays to kill cancer cells) for patients who are newly diagnosed with this lymphoma.

To participate in the trial, patients need to be between 14 and 80 years old and must have a confirmed diagnosis of ENKTL. They should not have received any prior chemotherapy or radiotherapy and must meet specific health criteria to ensure their bodies can handle the treatment. Participants can expect to receive the combined treatment and will be monitored closely for any side effects or responses to the therapy. It's important to note that certain individuals, such as those with specific health conditions or those who are pregnant, won't be eligible for this study. Overall, this trial aims to find a more effective first-line treatment for ENKTL and improve outcomes for patients diagnosed with this condition.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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