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ACTIVE NOT RECRUITING
NCT06637501
PHASE2

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

Sponsor: BeOne Medicines

View on ClinicalTrials.gov

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.

Official title: A Multicenter, Open-Label, Phase 2 Study to Investigate the Efficacy and Safety of Sonrotoclax Combined With Zanubrutinib Compared With Zanubrutinib Monotherapy in Adult Patients With Previously Untreated Chronic Lymphocytic Leukemia

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

94

Start Date

2024-11-14

Completion Date

2029-09

Last Updated

2026-03-20

Healthy Volunteers

No

Interventions

DRUG

Sonrotoclax

Administered orally

DRUG

Zanubrutinib

Administered orally

Locations (33)

Cleveland Clinic Florida

Weston, Florida, United States

Northwest Georgia Oncology Centers Marietta

Marietta, Georgia, United States

Illinois Cancer Specialists (Niles) Usor

Niles, Illinois, United States

University of Maryland Greenebaum Comprehensive Cancer Center

Baltimore, Maryland, United States

Nebraska Cancer Specialists (Satellite Site)

Omaha, Nebraska, United States

Nebraska Cancer Specialists

Omaha, Nebraska, United States

University of Nebraska Medical Center

Omaha, Nebraska, United States

New York Cancer and Blood Specialists

Shirley, New York, United States

Oncology Associates of Oregon Willamette Valley Cancer Center

Eugene, Oregon, United States

Texas Oncology Dfw

Dallas, Texas, United States

Texas Oncology Tyler

Tyler, Texas, United States

Utah Cancer Specialists

Salt Lake City, Utah, United States

Centro de Pesquisas Oncologicas Cepon

Florianópolis, Brazil

Hospital de Clinicas de Porto Alegre

Porto AlegreRS, Brazil

Instituto Dor de Pesquisa E Ensino Sao Paulo

São Paulo, Brazil

Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein

São Paulo, Brazil

Fujian Medical University Union Hospital

Fuzhou, Fujian, China

Henan Cancer Hospital

Zhengzhou, Henan, China

The First Peoples Hospital of Changzhou

Changzhou, Jiangsu, China

Jiangsu Province Hospital

Nanjing, Jiangsu, China

Rui Jin Hospital Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia

Brescia, Italy

Aou Careggi, Servizio Sanitario Toscana

Florence, Italy

Universita Degli Studi Di Modena Azienda Ospedaliere Policlinco

Modena, Italy

Aoor Villa Sofia Cervello

Palermo, Italy

Pratia Onkologia Katowice

Katowice, Poland

Pratia McM Krakow

Krakow, Poland

Uniwersytecki Szpital Kliniczny Nr 4 W Lublinie

Lublin, Poland

Uniwersytecki Szpital Kliniczny Hematology

Wroclaw, Poland

Hospital Clinic de Barcelona

Barcelona, Spain

Hospital de Cabuenes

Gijón, Spain

Hospital Universitario Fundacion Jimenez Diaz

Madrid, Spain