A Study of Acalabrutinib Plus Venetoclax Versus Venetoclax Plus Obinutuzumab in Previously Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Part of paid clinical trials in Tucson, Arizona.

Sponsor
AstraZeneca
Study ID
NCT05057494
Phase
PHASE3
Status
Active Not Recruiting

Conditions

  • Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Eligibility Criteria

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

Interventions

  • Acalabrutinib — DRUG
    Dose formulation: Capsule or Tablet
  • Venetoclax — DRUG
    Dose formulation: Tablet
  • Obinutuzumab — DRUG
    Dose formulation: Injection

Study Details

A study of acalabrutinib plus venetoclax (AV) versus venetoclax plus obinutuzumab (VO) in previously untreated chronic lymphocytic leukemia or small lymphocytic lymphoma.

Key Dates

Start date
Sep 12, 2022
Status verified
May 2026
Primary completion
Jul 15, 2027
Completion
Apr 10, 2029

Study Design

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

Arms

  • Experimental: Arm A: Acalabrutinib plus Venetoclax (AV)
    Participants will receive acalabrutinib and venetoclax orally.
  • Experimental: Arm B: Venetoclax plus Obinutuzumab (VO)
    Participants will receive Venetoclax orally and Obinutuzumab via IV infusion.

Primary Outcome Measure

Progression-free Survival (PFS) [ Time Frame: Until progressive disease (PD) [assessed Up to 6.6 Years]. ]

Locations (19)

FacilityCityStateZIPSite coordinators
Research SiteTucsonArizona85710-
Research SiteLa JollaCalifornia92093-0052-
Research SiteLongmontColorado80501-
Research SiteJacksonvilleFlorida32256-
Research SiteBostonMassachusetts02115-
Research SiteRochesterMinnesota55905-
Research SiteSt LouisMissouri63110-
Research SiteBuffaloNew York14263-
Research SiteNew Hyde ParkNew York11040-
Research SiteNew YorkNew York10065-
Research SiteRochesterNew York14642-
Research SiteCharlotteNorth Carolina28204-
Research SiteClevelandOhio44195-
Research SiteEugeneOregon97401-
Research SiteNashvilleTennessee37203-
Research SiteSalt Lake CityUtah84112-
Research SiteCharlottesvilleVirginia22908-
Research SiteSeattleWashington98104-
Research SiteSeattleWashington98109-

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