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Spots Global Cancer Trial Database for Nivolumab Plus Rituximab in First-line Follicular Lymphoma gr 1-3A

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Trial Identification

Brief Title: Nivolumab Plus Rituximab in First-line Follicular Lymphoma gr 1-3A

Official Title: First-line Treatment for Grade 1-3A Follicular Lymphoma Using Opdivo (Nivolumab) Plus Rituximab: The 1st FLOR Study

Study ID: NCT03245021

Interventions

Opdivo

Study Description

Brief Summary: Firstline treatment for grade 13a Follicular Lymphoma using Opdivo (nivolumab) plus Rituximab: The 1st FLOR trial

Detailed Description: 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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Ballarat Health, Ballarat, Victoria, Australia

Eastern Health, Box Hill, Victoria, Australia

Monash Health, Clayton, Victoria, Australia

Austin Health, Heidelberg, Victoria, Australia

St Vincent's Hospital, Melbourne, Victoria, Australia

Contact Details

Name: Eliza Hawkes, MD

Affiliation: Austin Health

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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