A Study to Investigate Sonrotoclax Combined With Zanubrutinib Versus Zanubrutinib Alone in Participants With Previously Untreated Chronic Lymphocytic Leukemia

NCT06637501 | Active Not Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: BGB-11417-2042024-513970-23-00
• Study Type: interventional
• Target: 94
• Locations: 6 countries
• Sites: 32

Brief Summary

The purpose of this study is to support the registration plan of sonrotoclax plus zanubrutinib treatment in participants with previously untreated chronic lymphocytic leukemia (CLL). This study is designed to assess the contribution of sonrotoclax to the efficacy outcome of the combination of zanubrutinib and sonrotoclax.

Conditions

Chronic Lymphocytic Leukemia

Keywords

CLL

Outcome Measures

Primary Outcomes (1)

• Complete Response (CR)/ Complete Response with Incomplete Bone Marrow Recovery (CRi) Rate

  Best CR/CRi rate per the Independent Review Committee (IRC) response assessment using the 2018 International Workshop on Chronic Lymphocytic Leukemia guidelines with modification for treatment-related lymphocytosis for participants with CLL

  Month 16

Secondary Outcomes (9)

• Undetectable Minimal Residual Disease at < 10^-4Sensitivity (uMRD4) Rate

  Month 16

• CR/CRi Rate per Investigator Response Assessment

  Month 16

• Overall Response Rate (ORR) per IRC and Investigator Response Assessment

  Up to 66 Months

• Duration of Response (DOR) per Investigator Response Assessment

  Up to 66 Months

• Time to Response (TTR) per IRC and Investigator Response Assessment

  Up to 66 Months

Study Arms (2)

Arm A: Combination Therapy: Sonrotoclax + Zanubrutinib

EXPERIMENTAL

Participants will receive sonrotoclax in combination with zanubrutinib daily for a fixed duration of 15 cycles.

Drug: Sonrotoclax; Drug: Zanubrutinib

Arm B: Monotherapy: Zanubrutinib

ACTIVE COMPARATOR

Participants will receive zanubrutinib monotherapy daily until disease progression or unacceptable toxicity, whichever occurs first.

Drug: Zanubrutinib

Interventions

Sonrotoclax DRUG

Administered orally

Also known as: BGB-11417

Arm A: Combination Therapy: Sonrotoclax + Zanubrutinib

Zanubrutinib DRUG

Administered orally

Also known as: BRUKINSA, BGB-3111

Arm A: Combination Therapy: Sonrotoclax + Zanubrutinib; Arm B: Monotherapy: Zanubrutinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Previously untreated adult patient ≥ 18 years with a confirmed diagnosis of CLL.
• CLL requiring treatment as per pre-defined criteria.
• Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0,1, or 2.
• Measurable disease by computed tomography (CT)/magnetic resonance imaging (MRI).
• Adequate marrow function.
• Adequate liver function as indicated by aspartate aminotransferase (AST) alanine aminotransferase (ALT) and serum total bilirubin.
• Adequate renal function.
• Life expectancy \> 6 months.
• Signed informed consent and able to comply with the study protocol in the investigator's judgment.
• Women of childbearing potential must be willing to use a highly effective method of birth control for the duration of the study and for ≥ 90 days after the last dose of study drug.

You may not qualify if:

• Known prolymphocytic leukemia or history of, or currently suspected, Richter's transformation
• Known central nervous system involvement
• Received previous systemic treatment for CLL
• Clinically significant cardiovascular disease
• Severe or debilitating pulmonary disease
• History of prior malignancy
• Active fungal, bacterial, and/or viral infection requiring systemic therapy
• Positive human immunodeficiency virus (HIV) serology (HIVAb) status or serologic status reflecting active hepatitis B or C infection
• Uncontrolled autoimmune hemolytic anemia or immune thrombocytopenia requiring treatment
• History of severe bleeding disorder such as hemophilia A, hemophilia B, von Willebrand disease, or history of spontaneous bleeding requiring blood transfusion or other medical intervention
• History of stroke or intracranial hemorrhage ≤ 6 months before the first dose of study treatment
• Unable to swallow capsules or tablets or diseases significantly affecting GI function
• Hypersensitivity to zanubrutinib, sonrotoclax, or any of its excipients
• Use of investigational agents within the last 4 weeks before screening
• Pregnant and lactating females

Sponsors & Collaborators

• BeOne Medicines: lead

Study Sites (32)

Cleveland Clinic Florida

Weston, Florida, 33331-3609, United States

Location

Northwest Georgia Oncology Centers Marietta

Marietta, Georgia, 30060-1152, United States

Location

Illinois Cancer Specialists (Niles) Usor

Niles, Illinois, 60714-5905, United States

Location

University of Maryland Greenebaum Comprehensive Cancer Center

Baltimore, Maryland, 21201-1544, United States

Location

Nebraska Cancer Specialists (Satellite Site)

Omaha, Nebraska, 68130-2042, United States

Location

Nebraska Cancer Specialists

Omaha, Nebraska, 68130-2042, United States

Location

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

Oncology Associates of Oregon Willamette Valley Cancer Center

Eugene, Oregon, 97401, United States

Location

Texas Oncology Dfw

Dallas, Texas, 75231-7001, United States

Location

Texas Oncology Tyler

Tyler, Texas, 75702-7522, United States

Location

Utah Cancer Specialists Cancer Center

Salt Lake City, Utah, 84107, United States

Location

Centro de Pesquisas Oncologicas Cepon

Florianópolis, 88034-000, Brazil

Location

Hospital de Clinicas de Porto Alegre

Porto AlegreRS, 900350-903, Brazil

Location

Instituto Dor de Pesquisa E Ensino Sao Paulo

São Paulo, 01401-004, Brazil

Location

Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein

São Paulo, 05652-900, Brazil

Location

Fujian Medical University Union Hospital

Fuzhou, Fujian, 350001, China

Location

Henan Cancer Hospital

Zhengzhou, Henan, 450000, China

Location

The First Peoples Hospital of Changzhou

Changzhou, Jiangsu, 213000, China

Location

Jiangsu Province Hospital

Nanjing, Jiangsu, 210029, China

Location

Rui Jin Hospital Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

Location

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310003, China

Location

Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia

Brescia, 25123, Italy

Location

Aou Careggi, Servizio Sanitario Toscana

Florence, 50134, Italy

Location

Universita Degli Studi Di Modena Azienda Ospedaliere Policlinco

Modena, 41124, Italy

Location

Aoor Villa Sofia Cervello

Palermo, 90146, Italy

Location

Pratia Onkologia Katowice

Katowice, 40-519, Poland

Location

Pratia McM Krakow

Krakow, 30-727, Poland

Location

Uniwersytecki Szpital Kliniczny Nr 4 W Lublinie

Lublin, 20-090, Poland

Location

Uniwersytecki Szpital Kliniczny Hematology

Wroclaw, 50-367, Poland

Location

Hospital Clinic de Barcelona

Barcelona, 08036, Spain

Location

Hospital de Cabuenes

Gijón, 33394, Spain

Location

Hospital Universitario Fundacion Jimenez Diaz

Madrid, 28040, Spain

Location

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell

Interventions

zanubrutinib

Condition Hierarchy (Ancestors)

Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Study Director

  BeOne Medicines

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2024
• First Posted: October 15, 2024
• Study Start: November 14, 2024
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): September 1, 2029
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: See plan description
• Access Criteria: See plan description

Locations

IT (4); CN (6); US (11); PL (4); ES (3); BR (4)