Description:
This study is designed to compare the overall response rate of zanubrutinib versus ibrutinib
in participants with relapsed/refractory chronic lymphocytic leukemia or small lymphocytic
lymphoma.
Title
- Brief Title: A Study of Zanubrutinib (BGB-3111) Versus Ibrutinib in Participants With Relapsed/Refractory Chronic Lymphocytic Leukemia
- 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
Clinical Trial IDs
- ORG STUDY ID:
BGB-3111-305
- SECONDARY ID:
2018-001366-42
- SECONDARY ID:
CTR20190098
- NCT ID:
NCT03734016
Conditions
- Chronic Lymphocytic Leukemia
- Small Lymphocytic Lymphoma
Interventions
Drug | Synonyms | Arms |
---|
Zanubrutinib | BGB-3111 | Zanubrutinib |
Ibrutinib | Imbruvica | Ibrutinib |
Purpose
This study is designed to compare the overall response rate of zanubrutinib versus ibrutinib
in participants with relapsed/refractory chronic lymphocytic leukemia or small lymphocytic
lymphoma.
Detailed Description
This is a global, Phase 3, randomized study of zanubrutinib versus ibrutinib in approximately
600 participants with relapsed/refractory chronic lymphocytic leukemia or small lymphocytic
lymphoma.
The primary efficacy endpoint is overall response rate determined by investigator assessment.
Participants will be randomized in a 1:1 manner to either zanubrutinib or ibrutinib.
Treatment with zanubrutinib and ibrutinib will be open label.
Trial Arms
Name | Type | Description | Interventions |
---|
Zanubrutinib | Experimental | Zanubrutinib will be orally administered until disease progression or unacceptable toxicity. | |
Ibrutinib | Active Comparator | Ibrutinib will be orally administered until disease progression or unacceptable toxicity. | |
Eligibility Criteria
Key Inclusion Criteria
1. Confirmed diagnosis of CLL or SLL that meets the 2008 IWCLL criteria
2. CLL/SLL requiring treatment per 2008 IWCLL criteria
3. Relapsed or refractory to at least 1 prior systemic therapy for CLL/SLL
4. Measurable disease by CT/magnetic resonance imaging (MRI)
5. ECOG performance status of 0, 1, or 2
6. Life expectancy ≥ 6 months
7. Adequate bone marrow function
8. Adequate renal and hepatic function
Key Exclusion Criteria
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, non-muscle-invasive bladder cancer, 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
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Overall response rate determined by investigator assessment |
Time Frame: | Up to 50 months |
Safety Issue: | |
Description: | |
Secondary Outcome Measures
Measure: | Progression-free survival determined by independent central review |
Time Frame: | Up to 50 months |
Safety Issue: | |
Description: | |
Measure: | Progression-free survival determined by investigator assessment |
Time Frame: | Up to 51 months |
Safety Issue: | |
Description: | |
Measure: | Duration of response determined by investigator assessment |
Time Frame: | Up to 51 months |
Safety Issue: | |
Description: | |
Measure: | Duration of response determined by independent central review |
Time Frame: | Up to 51 months |
Safety Issue: | |
Description: | |
Measure: | Time to treatment failure |
Time Frame: | Up to 51 months |
Safety Issue: | |
Description: | |
Measure: | Overall survival |
Time Frame: | Up to 51 months |
Safety Issue: | |
Description: | |
Measure: | Patient reported outcomes as assessed by EORTC-QLQ-C30 |
Time Frame: | Up to 51 months |
Safety Issue: | |
Description: | |
Measure: | Patient reported outcomes as assessed by EQ-5D-5L |
Time Frame: | Up to 51 months |
Safety Issue: | |
Description: | |
Measure: | Incidence of adverse events as assessed by CTCAE v4.03 [Safety and Tolerability] |
Time Frame: | 51 months |
Safety Issue: | |
Description: | |
Measure: | Rate of partial response with lymphocytosis (PR-L) or higher determined by independent central review |
Time Frame: | Up to 51 months |
Safety Issue: | |
Description: | Proportion of participants who achieve a CR/CRi + PR + nodular PR + PR-L |
Measure: | Overall response rate determined by independent central review |
Time Frame: | 51 months |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 3 |
Primary Purpose: | Interventional |
Overall Status: | Active, not recruiting |
Lead Sponsor: | BeiGene |
Trial Keywords
- Chronic Lymphocytic Leukemia
- Small Lymphocytic Lymphoma
- CLL
- SLL
- relapsed
- refractory
Last Updated
April 28, 2021