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

  • STATUS
    Recruiting
  • End date
    Jan 6, 2027
  • participants needed
    780
  • sponsor
    Acerta Pharma BV
Updated on 19 December 2021
fludarabine
cyclophosphamide
rituximab
venetoclax
chemoimmunotherapy
bendamustine
obinutuzumab
acalabrutinib
abt-199
acp-196

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.

Description

This randomized, global, multicenter, open-label, Phase 3 study will evaluate the efficacy and safety of AV and AVG versus chemoimmunotherapy (FCR or BR) in subjects with previously untreated CLL without del(17p) or TP53. Subjects will be randomized in a 1:1:1 ratio into 3 arms through a block stratified randomization procedure.

The study includes screening (35 days), treatment (from randomization until study drug discontinuation) and follow-up phase.

Details
Condition Chronic Lymphocytic Leukemia
Treatment Obinutuzumab, venetoclax, acalabrutinib, Chemoimmunotherapy
Clinical Study IdentifierNCT03836261
SponsorAcerta Pharma BV
Last Modified on19 December 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Men and women ≥18 years of age
Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
Diagnosis of CLL that meets published diagnostic criteria (Hallek et al. 2018)
Active disease per IWCLL 2018 criteria that requires treatment
Participants must use highly effective birth control throughout the study

Exclusion Criteria

Any prior CLL-specific therapies
Detected del(17p) or TP53 mutation
Transformation of CLL to aggressive non-Hodgkin lymphoma (NHL) (e.g., Richter's transformation, prolymphocytic leukemia [PLL], or diffuse large B cell lymphoma [DLBCL]), or central nervous system (CNS) involvement by leukemia
History of confirmed progressive multifocal leukoencephalopathy (PML)
Received any investigational drug within 30 days before first dose of study drug
Major surgical procedure within 30 days before the first dose of study drug
Significant cardiovascular disease such as symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of Screening, or any Class 3 or 4 cardiac disease. Note: Subjects with controlled, asymptomatic atrial fibrillation are allowed to enroll on study
Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach, or extensive small bowel resection that is likely to affect absorption, symptomatic inflammatory bowel disease, or partial or complete bowel obstruction, or gastric restrictions and bariatric surgery, such as gastric bypass
Received a live virus vaccination within 28 days of first dose of study drug
Known history of infection with human immunodeficiency virus (HIV)
Serologic status reflecting active hepatitis B or C infection
History of known hypersensitivity or anaphylactic reactions to study drugs or excipients
History of stroke or intracranial hemorrhage within 6 months before first dose of study drug
Known bleeding disorders
Requires or receiving anticoagulation with warfarin or equivalent vitamin K antagonists
Female participants must not be breastfeeding or pregnant
Concurrent participation in another therapeutic clinical trial
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