Lymphoma, B-Cell Clinical Trial
Official title:
Improving the Outcome of High-risk Aggressive B-cell Lymphoma Patients With Nivolumab Maintenance Therapy. The NivoM Trial
This trial is designed as a unicenter, single arm phase II trial. The aim of the trial is to test whether prognosis of high-risk Aggressive B cell Lymphoma (ABCL) patients who are in complete remission (CR) post immunochemotherapy can be improved by 2year nivolumab maintenance therapy. Participants will be recruited from Chaim Sheba Medical Center as well as from other medical centers in Israel through the Israeli lymphoma group. Therapy will be treated in Chaim Sheba Medical Center.
The rationale for prolonged nivolumab therapy in high-risk ABCL patients in CR following 1st line standard therapy is based on the hypothesis that the stimulation of immune system by Programmed cell death protein 1 (PD1) blockade will also facilitate the eradication of minimal residual disease (MRD), that is not apparent by positron emission tomography (PET) imaging, and eventually will prevent relapse and improve survival. The Study will include adult patients, age ≥18, with high risk (IPI≥3) ABCL, in CR according to PETCT, as defined by the Lugano Criteria, following first-line rituximab (R) and anthracycline-containing regimen. ;
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