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

First listed
Aug 17, 2018
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

Related Studies