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

NCT03836261 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 984

Last updated 2024-12-27

No results posted yet for this study

Summary

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

Conditions

Interventions

DRUG

Acalabrutinib

Acalabrutinib,

DRUG

Venetoclax

Venetoclax

DRUG

Chemoimmunotherapy

fludarabine/cyclophosphamide/rituximab (FCR), bendamustine/rituximab (BR)

DRUG

Obinutuzumab

Obinutuzumab

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • Acerta Pharma BV

    lead INDUSTRY

Principal Investigators

  • Jennifer Brown · Dana Farber Mass General Brigham Cancer Care Inc

  • Barbara Eichhorst · Universitätsklinikum Köln

  • Arnon Kater · Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

  • Paolo Ghia · OSPEDALE S. RAFFAELE - MILANO

  • John Seymour · Peter MacCallum Cancer Ctr

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
130 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-25
Primary Completion
2027-01-31
Completion
2027-01-31
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Austria
  • Brazil
  • Bulgaria
  • Canada
  • China
  • Czechia
  • Denmark
  • France
  • Germany
  • Hungary
  • Israel
  • Italy
  • Netherlands
  • Poland
  • Russia
  • Saudi Arabia
  • Slovakia
  • South Africa
  • South Korea
  • Spain
  • Sweden
  • Taiwan
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03836261 on ClinicalTrials.gov