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Monoclonal Antibodies

Rituximab + Immunotherapy for Follicular Lymphoma

Phase 1
Waitlist Available
Led By Caron A. Jacobson, MD
Research Sponsored by Dana-Farber Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

Study Summary

This trial is testing if these drugs can help treat people with follicular lymphoma.

Who is the study for?
This trial is for adults over 18 with follicular lymphoma that's relapsed after treatment or hasn't been treated yet, except those with severe allergies to monoclonal antibodies, autoimmune diseases, active infections, other cancers within the last three years (some exceptions apply), and certain heart conditions. Participants need functioning major organs and can't be pregnant or breastfeeding.Check my eligibility
What is being tested?
The study tests combinations of Rituximab with new drugs Utomilumab and Avelumab as potential treatments for follicular lymphoma. It aims to find out how well these drug combos work together in patients who have had previous treatments or are newly diagnosed.See study design
What are the potential side effects?
Possible side effects include allergic reactions to the drugs, immune system complications potentially affecting various organs, fatigue, infusion-related reactions like fever or chills, and increased risk of infections due to a weakened immune response.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Recommended phase 2 dosing
Secondary outcome measures
Complete response rate
Objective response rate
Overall Survival Rate
+8 more

Trial Design

3Treatment groups
Experimental Treatment
Group I: Rituximab+Utomilumab+PF04518600Experimental Treatment3 Interventions
Rituximab is administered intravenously per institutional standards for four weekly treatments for cycle 1 only Utomilumab is administered intravenously over 1 hour once every 4 weeks PF-04518600 is administered intravenously over 1 hour on day 1 and day 15
Group II: Rituximab+Avelumab+PF04518600Experimental Treatment3 Interventions
Rituximab is administered intravenously per institutional standards for four weekly treatments for cycle 1 only Avelumab is administered intravenously over 1 hour once every 2 weeks PF-04518600 is administered intravenously over 1 hour on day 1 and day 15
Group III: Rituximab +Utomilumab+AvelumabExperimental Treatment3 Interventions
Rituximab is administered intravenously per institutional standards for four weekly treatments for cycle 1 only Utomilumab is administered intravenously over 1 hour once every 4 weeks Avelumab is administered intravenously over 1 hour once every 2 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Avelumab
2018
Completed Phase 2
~2450
Rituximab
1999
Completed Phase 4
~1880
Utomilumab
2018
Completed Phase 2
~30

Find a Location

Who is running the clinical trial?

Dana-Farber Cancer InstituteLead Sponsor
1,080 Previous Clinical Trials
340,906 Total Patients Enrolled
PfizerIndustry Sponsor
4,582 Previous Clinical Trials
14,634,270 Total Patients Enrolled
Caron A. Jacobson, MDPrincipal InvestigatorDana-Farber Cancer Institute

Media Library

Avelumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03636503 — Phase 1
Follicular Lymphoma Research Study Groups: Rituximab +Utomilumab+Avelumab, Rituximab+Utomilumab+PF04518600, Rituximab+Avelumab+PF04518600
Follicular Lymphoma Clinical Trial 2023: Avelumab Highlights & Side Effects. Trial Name: NCT03636503 — Phase 1
Avelumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03636503 — Phase 1
~4 spots leftby Jun 2025
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