A Study of BR Alone Versus in Combination With Acalabrutinib in Subjects With Previously Untreated MCL

Part of paid clinical trials in Tucson, Arizona.

Sponsor
Acerta Pharma BV
Study ID
NCT02972840
Phase
PHASE3
Status
Active Not Recruiting

Conditions

  • Lymphoma, Mantle Cell

Eligibility Criteria

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

Interventions

  • Acalabrutinib — DRUG
    Administered orally (PO)
  • Bendamustine — DRUG
    Administered intravenously (IV)
  • Rituximab — DRUG
    Administered intravenously (IV)
  • Placebo — DRUG
    Placebo comparator

Study Details

This study is evaluating the efficacy of acalabrutinib in combination with bendamustine and rituximab (BR) compared with placebo plus BR in subjects with previously untreated mantle cell lymphoma.

Key Dates

Start date
Apr 5, 2017
Status verified
May 2026
Primary completion
Feb 15, 2027
Completion
Feb 15, 2027

Study Design

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

Arms

  • Experimental: Acalabrutinib in combination with bendamustine and rituximab
    Acalabrutinib administered twice per day (BID) orally (PO) plus bendamustine on Days 1 and 2 and rituximab on Day 1; cycles are repeated every 28 days.
  • Placebo Comparator: Placebo in combination with bendamustine and rituximab
    Matching placebo administered BID PO plus bendamustine on Days 1 and 2 and rituximab on Day 1; cycles are repeated every 28 days.

Primary Outcome Measure

Progression-free survival per the Lugano Classification for NHL in Arm 1 compared to Arm 2 [ Time Frame: Up to 6 years ]

Locations (32)

FacilityCityStateZIPSite coordinators
Research SiteTucsonArizona85719-
Research SiteDowneyCalifornia90241-
Research SiteSanta MonicaCalifornia90404-
Research SiteNew HavenConnecticut06510-
Research SiteWashington D.C.District of Columbia20007-
Research SiteTallahasseeFlorida32308-5304-
Research SiteWest Palm BeachFlorida33401-
Research SiteMariettaGeorgia30060-
Research SiteWestwoodKansas66205-
Research SiteLouisvilleKentucky40207-
Research SiteAnn ArborMichigan48109-
Research SiteRochesterMinnesota55905-0001-
Research SiteKansas CityMissouri64132-
Research SiteSt LouisMissouri63110-
Research SiteHackensackNew Jersey07601-
Research SiteMorristownNew Jersey07960-
Research SiteHawthorneNew York10532-
Research SiteLake SuccessNew York11042-
Research SitePortlandOregon97239-
Research SiteCharlestonSouth Carolina29425-
Research SiteGreenvilleSouth Carolina29615-
Research SiteChattanoogaTennessee37404-
Research SiteNashvilleTennessee37203-
Research SiteHoustonTexas77030-
Research SiteSan AntonioTexas78217-
Research SiteTylerTexas75702-
Research SiteCharlottesvilleVirginia22908-
Research SiteFort BelvoirVirginia22060-
Research SiteSeattleWashington98108-
Research SiteSeattleWashington98109-
Research SiteSeattleWashington98122-
Research SiteMorgantownWest Virginia26506-

Find similar trials in Tucson, AZ

By research site
Research Site· Tucson, AZResearch Site· Downey, CAResearch Site· Santa Monica, CAResearch Site· New Haven, CTResearch Site· Washington D.C., DCResearch Site· Tallahassee, FL

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