A Study of Zanubrutinib (BGB-3111) Versus Ibrutinib in Patients With Relapsed / Refractory Chronic Lymphocytic Leukemia

Status: Active

Description

This study is designed to compare the overall response rate of zanubrutinib versus ibrutinib in patients with relapsed / refractory chronic lymphocytic leukemia or small lymphocytic lymphoma.

Eligibility Criteria

Inclusion Criteria

  • Age 18 years or older
  • Confirmed diagnosis of CLL or SLL that meets the 2008 IWCLL criteria
  • CLL/SLL requiring treatment per 2008 IWCLL criteria
  • Relapsed or refractory to at least 1 prior systemic therapy for CLL/SLL
  • Measurable disease by CT/magnetic resonance imaging (MRI)
  • ECOG performance status of 0, 1, or 2
  • Life expectancy ≥ 6 months
  • Adequate bone marrow function
  • Adequate renal and hepatic function

Exclusion Criteria

  • Known prolymphocytic leukemia or history of, or currently suspected, Richter's transformation
  • Clinically significant cardiovascular disease.
  • Prior malignancy within the past 3 years, except for curatively treated basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix or breast
  • History of severe bleeding disorder or history of spontaneous bleeding requiring blood transfusion or other medical intervention
  • History of stroke or intracranial hemorrhage within 180 days before first dose of study drug
  • Severe or debilitating pulmonary disease
  • Active fungal, bacterial, and/or viral infection requiring systemic therapy
  • Known central nervous system involvement by leukemia or lymphoma
  • Known infection with HIV or active viral hepatitis B or C infection
  • Moderate or severe hepatic impairment, ie, Child-Pugh class B or C
  • Major surgery within 4 weeks of the first dose of study drug
  • Prior treatment with a BTK inhibitor
  • Toxicity from prior anticancer therapy that has not recovered to ≤ Grade 1
  • Pregnant or lactating women
  • Vaccination with a live vaccine within 35 days prior to the first dose of study drug
  • Hypersensitivity to zanubrutinib, ibrutinib, or any of the other ingredients in either drug
  • Concurrent participation in another therapeutic clinical trial

Locations & Contacts

California

Los Angeles
UCLA / Jonsson Comprehensive Cancer Center
Status: In review
Contact: April Johnson
Phone: 949-653-2959ext118
Email: AprilDJohnson@mednet.ucla.edu
Orange
UC Irvine Health / Chao Family Comprehensive Cancer Center
Status: Active
Name Not Available

Nebraska

Omaha
University of Nebraska Medical Center
Status: In review
Name Not Available

New York

New York
NYP / Columbia University Medical Center / Herbert Irving Comprehensive Cancer Center
Status: Active
Name Not Available

Ohio

Columbus
Ohio State University Comprehensive Cancer Center
Status: Approved
Name Not Available

Oregon

Portland
OHSU Knight Cancer Institute
Status: Active
Name Not Available

Texas

Houston
M D Anderson Cancer Center
Status: Active
Name Not Available

Washington

Seattle
Fred Hutch / University of Washington Cancer Consortium
Status: Active
Name Not Available

Trial Objectives and Outline

This is a global, Phase 3, randomized study of zanubrutinib versus ibrutinib in approximately 400 patients with relapsed/refractory chronic lymphocytic leukemia or small lymphocytic lymphoma. The primary efficacy endpoint is overall response rate determined by independent central review. Patients will be randomized in a 1:1 manner to either zanubrutinib or ibrutinib. Treatment with zanubrutinib and ibrutinib will be open label.

Trial Phase & Type

Trial Phase

Phase III

Trial Type

Treatment

Lead Organization

Lead Organization
BeiGene

Trial IDs

Primary ID BGB-3111-305
Secondary IDs NCI-2018-03516, 2018-001366-42, CTR20190098, BGB-3111-305 (ALPINE)
Clinicaltrials.gov ID NCT03734016