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RecruitingLast updated:13 May 2022

1st FLOR: This phase I trial is trying to determine whether it is safe to give the drug Nivolumab before and in combination with the drug Rituximab, in patients who have previously untreated Follicular LymphomaFirst-line Treatment for Grade 1-3A Follicular Lymphoma Using Opdivo (Nivolumab) Plus Rituximab

Clinical summary

Summary

This study will involve participants with a condition called Follicular NonHodgkin Lymphoma (Follicular Lymphoma). The main purpose of this study is to see if it is safe to give drug Nivolumab before and in combination with drug Rituximab and to see how effective Nivolumab is in patients who have had no previous drug treatment for their lymphoma. In particular, we will be monitoring for any specific side effects which may be increased by adding Nivolumab to Rituximab treatment, including monitoring of the immune system. Participants will be reviewed at baseline and prior to each cycle of treatment for toxicity, scans will be performed at baseline, after 4 cycles of nivolumab, after 8 cycles of nivolumab +/rituximab and at 6 months post induction treatment phase and following completion of treatment, participants will be followed up for a total of 5 years (every 3 months for 2 years, every 6 months for 3 years). In participants with relapsed disease, these will be followed for survival every 3 months.

Age

People18+

Phase

I

Trial Acronym

1st FLOR

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Trial Identifiers

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Commercial Sponsor

Bristol-Myers Squibb (BMS)

Scientific Title

First-line Treatment for Grade 1-3A Follicular Lymphoma Using Opdivo (Nivolumab) Plus Rituximab

Eligibility

Inclusion

  • You have had certain treatments, surgical procedures or drugs.
  • You have previously been treated (or are currently being treated) on a clinical trial.

Exclusion

  • You have been diagnosed with cancer, but have not received any treatment.
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Clinical trials have complex eligibility criteria.

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