Summary

for people ages 18 years and up (full criteria)
at UC Irvine UCLA
study started
estimated completion
Herbert Eradat(ucla)Susan O'Brien(uci)

Description

Summary

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.

Official Title

A Phase 3, Randomized Study of Zanubrutinib (BGB-3111) Compared With Ibrutinib in Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Details

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.

Keywords

Chronic Lymphocytic Leukemia Small Lymphocytic Lymphoma CLL SLL relapsed refractory Lymphoma Leukemia Leukemia, Lymphoid Leukemia, Lymphocytic, Chronic, B-Cell Zanubrutinib BGB-3111 Ibrutinib

Eligibility

You can join if…

Open to people ages 18 years and up

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

You CAN'T join if...

  1. Known prolymphocytic leukemia or history of, or currently suspected, Richter's transformation
  2. Clinically significant cardiovascular disease.
  3. 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
  4. History of severe bleeding disorder or history of spontaneous bleeding requiring blood transfusion or other medical intervention
  5. History of stroke or intracranial hemorrhage within 180 days before first dose of study drug
  6. Severe or debilitating pulmonary disease
  7. Active fungal, bacterial, and/or viral infection requiring systemic therapy
  8. Known central nervous system involvement by leukemia or lymphoma
  9. Known infection with HIV or active viral hepatitis B or C infection
  10. . Moderate or severe hepatic impairment, ie, Child-Pugh class B or C
  11. . Major surgery within 4 weeks of the first dose of study drug
  12. . Prior treatment with a BTK inhibitor
  13. . Toxicity from prior anticancer therapy that has not recovered to ≤ Grade 1
  14. . Pregnant or lactating women
  15. . Vaccination with a live vaccine within 35 days prior to the first dose of study drug
  16. . Hypersensitivity to zanubrutinib, ibrutinib, or any of the other ingredients in either drug
  17. . Concurrent participation in another therapeutic clinical trial

Locations

  • David Geffen School of Medicine at UCLA not yet accepting patients
    Los Angeles California 90095 United States
  • University of California Irvine Medical Center accepting new patients
    Orange California 92868 United States

Lead Scientists

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
BeiGene
ID
NCT03734016
Phase
Phase 3
Study Type
Interventional
Last Updated