drugset / Trial / NCT03021057

Pembrolizumab for T/NK-cell lymphomasNK-cell Lymphomas

NCT03021057 ↗

NaSingle-groupOpen-labelTreatment

Summary

Conventional chemotherapeutic regimens designed for aggressive B-cell lymphomas are generally less effective when applied to mature T-cell or NK-cell lymphomas. The treatment outcome for relapsed or refractory disease is especially poor. This is a single centre, prospective, non-randomized, open-label, phase II study to evaluate the efficacy of pembrolizumab in patients with relapsed or refractory mature T-cell or NK-cell lymphomas. Patients will receive pembrolizumab 200mg i.v. once every 3 weeks until disease progression or unacceptable toxicity. A baseline radiological assessment by positron emission tomography / computed tomography (PET/CT) scan is obtained before commencement of treatment. Tumor response and progression are evaluated by physical examination, standard laboratory tests, and PET/CT scan according to standard criteria. Standard response criteria for non-Hodgkin lymphomas are used for assessment . PET/CT scan will be done at week 12, week 24, week 36 and every 18 weeks thereafter.

Timeline

Start
2016-12-01
Primary completion
2020-06
Completion
2020-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Pembrolizumab Monoclonal antibody 200 mg Intravenous