A Combination of Acalabrutinib With R-CHOP in Subjects With Previously Untreated Non-GCB DLBCL (ACE-LY-312)

Part of paid clinical trials in Tucson, Arizona.

Sponsor
Acerta Pharma BV
Study ID
NCT04529772
Phase
PHASE3
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • acalabrutinib — DRUG
    Investigational Product
  • placebo — DRUG
    Placebo comparator
  • Prednisone — DRUG
    Investigational Product
  • Rituximab — DRUG
    Investigational Product
  • Cyclophosphamide — DRUG
    Investigational Product
  • Vincristine — DRUG
    Investigational Product
  • Doxorubicin — DRUG
    Investigational Product

Study Details

Phase 3 randomized, double-blind, placebo-controlled, study assessing the efficacy and safety of acalabrutinib plus rituximab,cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) vs placebo plus R-CHOP in subjects ≤75 years of age with previously untreated non-germinal center diffuse large B-cell lymphoma.

Key Dates

Start date
Oct 8, 2020
Status verified
Mar 2026
Primary completion
Feb 22, 2027
Completion
Feb 22, 2027

Study Design

Enrollment
611 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: acalabrutinib + R-CHOP
    Acalabrutinib plus Rituximab, Cyclosphosphamide, Doxorubicin, Vincristine and Prednisone (R-CHOP)
  • Placebo Comparator: placebo + R-CHOP
    Placebo plus Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone (R-CHOP)

Primary Outcome Measure

Progression-free survival (PFS) per the Lugano Classification for NHL in Arm A compared to Arm B [ Time Frame: at every single visit up to 60 months ]

Locations (32)

FacilityCityStateZIPSite coordinators
Research SiteTucsonArizona85711-
Research SiteLittle RockArkansas72205-
Research SiteIrvineCalifornia92618-
Research SiteAuroraColorado80012-
Research SiteNorwichConnecticut06360-
Research SiteFort MyersFlorida33901-
Research SiteOrlandoFlorida32804-
Research SiteSt. PetersburgFlorida33705-1449-
Research SiteTallahasseeFlorida32308-5304-
Research SiteWest Palm BeachFlorida33401-
Research SiteFort WayneIndiana46845-
Research SiteDes MoinesIowa50309-
Research SiteWichitaKansas67214-
Research SiteLouisvilleKentucky40207-
Research SiteBaltimoreMaryland21201-
Research SiteGrand RapidsMichigan49503-
Research SiteMinneapolisMinnesota55407-
Research SiteSt LouisMissouri63129-
Research SiteAlbanyNew York12208-
Research SiteNew YorkNew York10028-
Research SiteNew YorkNew York10065-
Research SiteStony BrookNew York11795-
Research SiteCharlotteNorth Carolina28204-
Research SiteWinston-SalemNorth Carolina27103-
Research SiteEugeneOregon97401-
Research SitePortlandOregon97239-
Research SitePhiladelphiaPennsylvania19111-
Research SitePittsburghPennsylvania15212-
Research SiteNashvilleTennessee37203-
Research SiteFort Sam HoustonTexas78234-
Research SiteLubbockTexas79410-
Research SiteSalemVirginia24153-

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