Rituximab + Immunotherapy in Follicular Lymphoma

Part of paid clinical trials in Duarte, California.

Sponsor
Dana-Farber Cancer Institute
Study ID
NCT03636503
Phase
PHASE1
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

  • Rituximab — DRUG
    Rituximab works by targeting the CD20 antigen on normal and malignant B-cells. Then the body's natural immune defenses are recruited to attack and kill the marked B-cells. Stem cells (young cells in the bone marrow that will develop into the various types of cells) do not have the CD20 antigen. This allows healthy B-cells to regenerate after treatment
  • Utomilumab — DRUG
    Utomilumab is a drug which may stimulate the immune system against tumor cells. Because it activate the immune system, it is sometimes called immunotherapy drug
  • Avelumab — DRUG
    Avelumab is a drug which may stimulate the immune system against tumor cells. Because it activate the immune system, it is sometimes called immunotherapy drug
  • PF04518600 — DRUG
    In the presence of tumor-associated antigens (TAAs), this may promote a T-cell-mediated immune response against TAA-expressing tumor cells. OX40

Study Details

This research study is studying several new investigational drug combinations as a possible treatment for follicular lymphoma. The drugs involved are: * Rituximab * Utomilumab * Avelumab * PF-04518600

Key Dates

Start date
Oct 30, 2018
Status verified
Jan 2025
Primary completion
Jul 23, 2021
Completion
Jul 30, 2023

Study Design

Enrollment
24 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Rituximab+Utomilumab+Avelumab-3mg
    * 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, 3mg/kg
  • Experimental: Rituximab+Utomilumab+Avelumab-10mg
    * 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, 10mg/kg
  • Experimental: PF04518600-0.3mg
    -PF-04518600 is administered intravenously over 1 hour on day 1 and day 15, 0.3mg/kg
  • Experimental: Rituximab+PF04518600-0.3mg
    * Rituximab is administered intravenously per institutional standards for four weekly treatments for cycle 1 only * PF-04518600 is administered intravenously over 1 hour on day 1 and day 15, 0.3mg/kg
  • Experimental: Rituximab+Utomilumab+PF04518600-0.3mg
    * 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, 0.3mg/kg
  • Experimental: Rituximab+PF04518600-0.3mg+Avelumab-3mg
    * 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, 3mg/kg
  • Experimental: Rituximab+PF04518600-0.3mg+Avelumab-10mg
    * 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, 10mg/kg

Primary Outcome Measure

Recommended Phase 2 Dosing [ Time Frame: 6 months total, assessed after each 28-day cycle ]

Locations (6)

FacilityCityStateZIPSite coordinators
City of HopeDuarteCalifornia91010-
Yale New-Haven HospitalNew HavenConnecticut06510-
Emory UniversityAtlantaGeorgia30322-
University of ChicagoChicagoIllinois60637-
Dana Farber Cancer InstituteBostonMassachusetts02215-
Washington University in St. LouisSt LouisMissouri63130-

Find similar trials in Duarte, CA

By research site
City of Hope· Duarte, CAYale New-Haven Hospital· New Haven, CTEmory University· Atlanta, GAUniversity of Chicago· Chicago, ILDana Farber Cancer Institute· Boston, MAWashington University in St. Louis· St Louis, MO

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