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A Phase 3, Open-Label, Randomized Study of Sonrotoclax (BGB-11417) Plus Zanubrutinib (BGB-3111) Compared With Venetoclax Plus Obinutuzumab in Patients With Previously Untreated Chronic Lymphocytic Leukemia
EU CTIS ID: 2023-506948-17-00
What this study is testing
Cohort 1: To compare efficacy between Arm A (sonrotoclax plus zanubrutinib [SZ]) versus Arm B (venetoclax plus obinutuzumab [VO]), as measured by progression-free survival (PFS) determined by independent review committee (IRC). Intermediate (Cohort 1): To compare the rate of undetectable minimal residual disease (uMRD) among patients enrolled to Arm A versus Arm B.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patients aged ≥ 18 years will have a confirmed diagnosis of CLL, based on Hallek et al 2018, requiring treatment as defined by ≥ 1 of the following: progressive bone marrow failure; massive, progressive, or symptomatic splenomegaly; massive, progressive, or symptomatic lymphadenopathy; progressive lymphocytosis with rapid doubling time; symptomatic or functional extranodal involvement; and/or constitutional symptoms.
You likely can't join if
- Eligible patients must have ≥ 1 measurable lymph node based on computed tomography/magnetic resonance imaging and no prior systemic treatment for CLL; no history of or known prolymphocytic leukemia or history of, or currently suspected, Richter’s transformation at time of consideration for study; no ongoing clinically significant cardiovascular disease; and no active infection including hepatitis B or C virus or HIV. Patients who require treatment with warfarin or other vitamin K antagonists will be excluded.
The study team makes the final eligibility decision.
Where it's taking place
- Israel
- Brazil
- Australia
- Korea, Republic of
- New Zealand
- Turkey
- United States
- Canada
- United Kingdom
- China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Israel; Brazil; Australia; Korea, Republic of; New Zealand; Turkey and 4 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.