A Study of Zanubrutinib (BGB-3111) Versus Ibrutinib in Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia (ALPINE)
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|ClinicalTrials.gov Identifier: NCT03734016|
Recruitment Status : Recruiting
First Posted : November 7, 2018
Last Update Posted : September 18, 2019
|Condition or disease||Intervention/treatment||Phase|
|Chronic Lymphocytic Leukemia Small Lymphocytic Lymphoma||Drug: BGB-3111 Drug: Ibrutinib||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||400 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||November 1, 2018|
|Estimated Primary Completion Date :||February 2021|
|Estimated Study Completion Date :||October 2025|
Zanubrutinib (BGB-3111) will be orally administered until disease progression or unacceptable toxicity.
160 mg orally twice daily
Other Name: Zanubrutinib
Active Comparator: Ibrutinib
Ibrutinib will be orally administered until disease progression or unacceptable toxicity.
Ibrutinib 420 mg orally once daily
Other Name: Imbruvica
- Overall response rate determined by independent central review [ Time Frame: 29 months ]
- Progression-free survival determined by independent central review [ Time Frame: 65 months ]
- Progression-free survival determined by investigator assessment [ Time Frame: 65 months ]
- Duration of response determined by independent central review [ Time Frame: 65 months ]
- Duration of response determined by investigator assessment [ Time Frame: 65 months ]
- Time to treatment failure [ Time Frame: 65 months ]
- Overall survival [ Time Frame: 65 months ]
- Patient reported outcomes as assessed by EORTC-QLQ-C30 [ Time Frame: 65 months ]
- Patient reported outcomes as assessed by EQ-5D-5L [ Time Frame: 65 months ]
- Incidence of adverse events as assessed by CTCAE v4.03 [Safety and Tolerability] [ Time Frame: 80 months ]
- Correlation between prognostic and predictive biomarkers and clinical outcomes [ Time Frame: 65 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03734016
|Contact: Tommi Salmi, MDfirstname.lastname@example.org|
|Contact: James Hilger, PhDemail@example.com|
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