Study of Acalabrutinib (ACP-196) Versus Ibrutinib in Previously Treated Participants With High Risk Chronic Lymphocytic Leukemia (CLL)

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Acerta Pharma BV
Study ID
NCT02477696
Phase
PHASE3
Status
Active Not Recruiting

Conditions

Eligibility Criteria

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

Interventions

  • Acalabrutinib — DRUG
    Participants will receive oral acalabrutinib as stated in arm description.
  • Ibrutinib — DRUG
    Participants will receive oral ibrutinib as stated in arm description.

Study Details

This study is designed to evaluate progression-free survival (PFS) endpoint for acalabrutinib versus (vs) ibrutinib in previously treated chronic lymphocytic leukemia.

Key Dates

Start date
Jul 28, 2015
Status verified
May 2026
Primary completion
Sep 15, 2020
Completion
Jan 3, 2028

Study Design

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

Arms

  • Experimental: Acalabrutinib
    Participants will receive oral acalabrutinib 100 mg twice daily (BID) until disease progression (PD), or unacceptable toxicity, or other reasons for discontinuation, whichever occurs first.
  • Active Comparator: Ibrutinib
    Participants will receive oral ibrutinib 420 mg once daily (QD) until PD, or unacceptable toxicity, or other reasons for discontinuation, whichever occurrs first.

Primary Outcome Measure

Progression-free Survival (PFS) Based on Independent Review Committee (IRC) Assessment [ Time Frame: Baseline (Days -28 to -1) through 55.2 months (maximum observed duration) ]

Locations (31)

FacilityCityStateZIPSite coordinators
Research SitePhoenixArizona85054-
Research SiteAnaheimCalifornia92801-
Research SiteBerkeleyCalifornia94704-
Research SiteDuarteCalifornia91010-
Research SiteLa JollaCalifornia92093-
Research SiteLos AngelesCalifornia90095-
Research SitePalo AltoCalifornia94304-
Research SiteSanta RosaCalifornia95403-
Research SiteJacksonvilleFlorida32224-
Research SiteTampaFlorida33612-
Research SiteAthensGeorgia30607-
Research SiteHarveyIllinois60426-
Research SitePeoriaIllinois61615-
Research SiteWichitaKansas67214-
Research SiteMinneapolisMinnesota55426-
Research SiteRochesterMinnesota55905-
Research SiteBillingsMontana59102-
Research SiteHackensackNew Jersey?07601-
Research SiteLake SuccessNew York11042-
Research SiteNew Hyde ParkNew York11042-
Research SiteNew YorkNew York10021-
Research SiteNew YorkNew York10029-
Research SiteNew YorkNew York10065-
Research SiteDurhamNorth Carolina27710-
Research SiteColumbusOhio43210-
Research SitePhiladelphiaPennsylvania19104-
Research SiteHoustonTexas77030-
Research SiteRound RockTexas78665-
Research SiteCharlottesvilleVirginia22908-
Research SiteTacomaWashington98405-
Research SiteNorthwest WAWisconsin20007-

Find similar trials in Phoenix, AZ

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
Research Site· Phoenix, AZResearch Site· Anaheim, CAResearch Site· Berkeley, CAResearch Site· Duarte, CAResearch Site· La Jolla, CAResearch Site· Los Angeles, CA

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