NCT03569696

Improving the Outcome of High-risk Aggressive B-cell Lymphoma Patients With Nivolumab Maintenance Therapy

Improving the Outcome of High-risk Aggressive B-cell Lymphoma Patients With Nivolumab Maintenance Therapy. The NivoM Trial

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Meirav Kedmi MD · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Lymphoma, B-Cell

Interventions

Type	Name	Description
BIOLOGICAL	nivolumab	The treatment phase will begin 10 ± 2 weeks from completion of R- anthracycline based therapy. Cycle 1 day 1 will occur within 72 hours from enrolment. Study treatment will be continued until nivolumab discontinuation due to disease progression, unacceptable toxicity or completion of 2 years or 30 doses of therapy. Study drug nivolumab will be administered intravenously every 2 weeks as described in the investigator brochure (IB) in a dose of 240mg over 30 minutes 46 for 8 cycles and then 480mg every 4 weeks for two years (cycle 9-30)to a maximum of 30 doses whichever comes first.

Timeline

• Start date: 2018-10-08
• Primary completion: 2023-07-01
• Completion: 2023-09-01
• First posted: 2018-06-26
• Last updated: 2019-04-23

Locations

1 site across 1 country: Israel