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

Sponsor
Meirav Kedmi MD
Study ID
NCT03569696
Phase
PHASE2
Status
Unknown

Conditions

  • Lymphoma, B-Cell

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • nivolumab — BIOLOGICAL
    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.

Study Details

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.

Key Dates

Start date
Oct 8, 2018
Status verified
Apr 2019
Primary completion
Jul 31, 2023
Completion
Sep 30, 2023

Study Design

Enrollment
50 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Nivolumab
    Nivolumab will be administered intravenously every 2 weeks in a dose of 240mg over 30 minutes for 8 cycles and then 480mg every 4 weeks for two years (cycle 9-30)to a maximum of 30 doses whichever comes first.

Primary Outcome Measure

disease progression [ Time Frame: 3 years post diagnosis of aggressive B cell lymphoma. ]

Central Contacts

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