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

NCT03569696 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2019-04-23

No results posted yet for this study

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.

Conditions

  • Lymphoma, B-Cell

Interventions

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.

Sponsors & Collaborators

  • Meirav Kedmi MD

    lead OTHER_GOV

Principal Investigators

  • Meirav Kedmi, MD · Sheba Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-08
Primary Completion
2023-07-31
Completion
2023-09-30

Countries

  • Israel

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03569696 on ClinicalTrials.gov