A Study of Surovatamig (AZD0486) Plus Rituximab in Previously Untreated Follicular Lymphoma Patients

Part of paid clinical trials in Huntsville, Alabama.

Sponsor
AstraZeneca
Study ID
NCT06549595
Phase
PHASE3
Status
Recruiting
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Conditions

  • Untreated Follicular Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 130 Years
Healthy Volunteers
Not accepted

Interventions

  • Surovatamig — DRUG
    a fully human bispecific monoclonal IgG4 antibody
  • R-CHOP — DRUG
    Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone
  • R-CVP — DRUG
    Rituximab, Cyclophosphamide, Vincristine and Prednisone
  • BR — DRUG
    Bendamustine, Rituximab

Study Details

This is a global, randomised, Phase III, multicentre, open-label study evaluating the efficacy, safety and the degree of added benefit of the Surovatamig (AZD0486) plus rituximab combination compared to Investigator's choice of 3 standard immunochemotherapy regimen, conducted in participants with untreated FL.

Key Dates

Start date
Aug 7, 2024
Status verified
May 2026
Primary completion
Nov 26, 2031
Completion
Nov 26, 2031

Study Design

Enrollment
1,018 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Rituximab, Surovatamig - A
    Surovatamig regimen A plus rituximab
  • Experimental: Rituximab, Surovatamig - B
    Surovatamig regimen B plus rituximab
  • Active Comparator: Chemoimmunotherapy
    Investigator's choice between 3 standard immunochemotherapy regimen (R-CHOP, R-CVP, or B-R followed by rituximab maintenance)

Primary Outcome Measure

SRI Primary: Incidence, nature and severity of AEs and SAEs. Incidence and nature of study drug discontinuations, dose reductions, and dose delays due to AEs [ Time Frame: Up to 10 years ]

Central Contacts

Locations (51)

FacilityCityStateZIPSite coordinators
Research SiteHuntsvilleAlabama35805-
Research SiteAnchorageAlaska99508-
Research SitePhoenixArizona85054-
Research SiteClovisCalifornia93611-
Research SiteLos AlamitosCalifornia90720-
Research SiteSan DiegoCalifornia92121-
Research SiteSanta MonicaCalifornia90404-
Research SiteAuroraColorado80045-
Research SiteNew HavenConnecticut06510-
Research SiteNewarkDelaware19713-
Research SiteJacksonvilleFlorida32224-
Research SiteAtlantaGeorgia30322-
Research SiteMaconGeorgia31201-
Research SiteEvanstonIllinois60201-
Research SitePeoriaIllinois61615-
Research SiteFort WayneIndiana46804-
Research SiteDes MoinesIowa50309-
Research SiteIowa CityIowa52242-
Research SiteLexingtonKentucky40536-
Research SiteLouisvilleKentucky40207-
Research SiteBaton RougeLouisiana70808-
Research SiteBaltimoreMaryland21201-
Research SiteBethesdaMaryland20817-
Research SiteColumbiaMaryland21044-
Research SiteBostonMassachusetts02114-
Research SiteBostonMassachusetts02215-
Research SiteAnn ArborMichigan48109-
Research SiteDetroitMichigan48201-
Research SiteYpsilantiMichigan48197-
Research SiteSaint PaulMinnesota55102-
Research SiteSpringfieldMissouri65807-
Research SiteHackensackNew Jersey07601-
Research SiteNew BrunswickNew Jersey08901-
Research SiteNew Hyde ParkNew York11042-
Research SiteNew YorkNew York10016-
Research SiteNew YorkNew York10032-
Research SiteNew YorkNew York10065-
Research SiteCharlotteNorth Carolina28204-
Research SiteWinston-SalemNorth Carolina27103-
Research SiteBlue AshOhio45242-
Research SiteColumbusOhio43210-
Research SiteEugeneOregon97401-
Research SitePittsburghPennsylvania15232-
Research SiteNashvilleTennessee37203-
Research SiteShenandoahTexas77380-
Research SiteTylerTexas75702-
Research SiteSalt Lake CityUtah84112-
Research SiteFairfaxVirginia22031-
Research SiteRichmondVirginia23219-
Research SiteTacomaWashington98405-
Research SiteMadisonWisconsin53792-

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