Study of Acalabrutinib (ACP-196) in Combination With Venetoclax (ABT-199), With and Without Obinutuzumab (GA101) Versus Chemoimmunotherapy for Previously Untreated CLL

Part of paid clinical trials in Los Angeles, California.

Sponsor
Acerta Pharma BV
Study ID
NCT03836261
Phase
PHASE3
Status
Active Not Recruiting

Conditions

Eligibility Criteria

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

Interventions

  • Acalabrutinib — DRUG
    Acalabrutinib,
  • Venetoclax — DRUG
    Venetoclax
  • Chemoimmunotherapy — DRUG
    fludarabine/cyclophosphamide/rituximab (FCR), bendamustine/rituximab (BR)
  • Obinutuzumab — DRUG
    Obinutuzumab

Study Details

The purpose of this study is to evaluate the efficacy and safety of acalabrutinib in combination with venetoclax and acalabrutinib in combination with venetoclax with and without obinutuzumab compared to chemoimmunotherapy in subjects with previously untreated CLL

Key Dates

Start date
Feb 25, 2019
Status verified
Dec 2024
Primary completion
Jan 31, 2027
Completion
Jan 31, 2027

Study Design

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

Arms

  • Experimental: Acalabrutinib, Venetoclax
    Acalabrutinib in combination with Venetoclax
  • Experimental: Acalabrutinib, Venetoclax, Obinutuzumab
    Acalabrutinib in combination with Venetoclax with Obinutuzumab
  • Active Comparator: Chemoimmunotherapy
    Chemoimmunotherapy FCR: Fludarabine, Cyclophosphamide and Rituximab BR: Bendamustine and Rituximab

Primary Outcome Measure

To evaluate the efficacy of acalabrutinib with venetoclax (Arm A) compared to chemoimmunotherapy fludarabine/cyclophosphamide/rituximab [FCR] or bendamustine/rituximab [BR] (Arm C): PFS [ Time Frame: 6 years ]

Locations (16)

FacilityCityStateZIPSite coordinators
Research SiteLos AngelesCalifornia90095-
Research SiteRedondo BeachCalifornia90277-
Research SiteFort WayneIndiana46804-
Research SiteWichitaKansas67214-
Research SiteLouisvilleKentucky40207-
Research SiteNew OrleansLouisiana70056-
Research SiteBaltimoreMaryland21201-
Research SiteBostonMassachusetts02215-
Research SiteNew YorkNew York10021-
Research SiteCharlotteNorth Carolina28204-
Research SiteCantonOhio44718-
Research SitePittsburghPennsylvania15224-
Research SitePittsburghPennsylvania15232-
Research SiteFort Sam HoustonTexas78234-
Research SiteSpokaneWashington99208-
Research SiteTacomaWashington98405-

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