Summary

Eligibility
for people ages 18-130 (full criteria)
Location
at UCLA
Dates
study started
estimated completion

Description

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.

Official Title

A Randomized, Multicenter, Open-Label, Phase 3 Study to Compare the Efficacy and Safety of Acalabrutinib (ACP-196) in Combination With Venetoclax With and Without Obinutuzumab Compared to Investigator's Choice of Chemoimmunotherapy in Subjects With Previously Untreated Chronic Lymphocytic Leukemia Without Del(17p) or TP53 Mutation

Details

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.

Keywords

Chronic Lymphocytic Leukemia CLL Chronic Leukemia Lymphocytic Leukemia Leukemia, Lymphoid Leukemia, Lymphocytic, Chronic, B-Cell Venetoclax Obinutuzumab Acalabrutinib Chemoimmunotherapy Acalabrutinib, Venetoclax Acalabrutinib, Venetoclax, Obinutuzumab

Eligibility

You can join if…

Open to people ages 18-130

  • 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.

You CAN'T join if...

  • 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.

Locations

  • Research Site accepting new patients
    Los Angeles California 90095 United States
  • Research Site not yet accepting patients
    Fountain Valley California 92708 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Acerta Pharma BV
ID
NCT03836261
Phase
Phase 3
Study Type
Interventional
Last Updated