A Study of Acalabrutinib vs Investigator's Choice of Idelalisib Plus Rituximab or Bendamustine Plus Rituximab in R/R CLL

Part of paid clinical trials in Chandler, Arizona.

Sponsor
Acerta Pharma BV
Study ID
NCT02970318
Phase
PHASE3
Status
Active Not Recruiting

Conditions

Eligibility Criteria

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

Interventions

  • Acalabrutinib (ACP-196) — DRUG
    Acalabrutinib monotherapy
  • Rituximab — DRUG
    Rituximab in combination with idelalisib or bendamustine
  • Idelalisib — DRUG
    Idelalisib in combination with rituximab
  • Bendamustine — DRUG
    Bendamustine in combination with rituximab

Study Details

This study is designed to evaluate the efficacy of acalabrutinib compared with rituximab in combination with idelalisib or bendamustine in previously treated subjects with chronic lymphocytic leukemia (CLL).

Key Dates

Start date
Feb 2, 2017
Status verified
May 2026
Primary completion
Sep 3, 2021
Completion
Oct 1, 2027

Study Design

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

Arms

  • Experimental: Acalabrutinib (ACP-196)
    Acalabrutinib (ACP-196) Monotherapy
  • Active Comparator: Rituximab Plus Idelalisib or Bendamustine
    Investigator's Choice of Rituximab Plus Idelalisib or Bendamustine

Primary Outcome Measure

Progression-free Survival (PFS) Per Independent Review Committee (IRC) Assessment [ Time Frame: IRC assessments from randomization date until disease progression or death or IRC discontinuation on 15Jan2019 (as IA per this data cutoff showed crossing superiority boundary) whichever came first, up to 22 months of follow-up ]

Locations (13)

FacilityCityStateZIPSite coordinators
Research SiteChandlerArizona85224-
Research SiteOxnardCalifornia93030-
Research SiteAthensGeorgia30607-
Research SiteJolietIllinois60435-
Research SiteCedar RapidsIowa52403-
Research SiteMount SterlingKentucky40353-
Research SiteSaint CloudMinnesota56303-
Research SiteLincolnNebraska68506-
Research SiteBrickNew Jersey08724-
Research SiteNyackNew York10960-
Research SiteCantonOhio44719-
Research SiteFort Sam HoustonTexas78234-
Research SiteRound RockTexas78665-

Find similar trials in Chandler, AZ

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
Research Site· Chandler, AZResearch Site· Oxnard, CAResearch Site· Athens, GAResearch Site· Joliet, ILResearch Site· Cedar Rapids, IAResearch Site· Mount Sterling, KY

Related Studies