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

Last updated: February 17, 2025
Sponsor: BeiGene
Overall Status: Active - Recruiting

Phase

2

Condition

Lymphoproliferative Disorders

Lymphocytic Leukemia, Chronic

Chronic Lymphocytic Leukemia

Treatment

Sonrotoclax

Zanubrutinib

Clinical Study ID

NCT06637501
BGB-11417-204
2024-513970-23-00
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Previously untreated adult patient ≥ 18 years with a confirmed diagnosis of CLL.

  2. CLL requiring treatment as per pre-defined criteria.

  3. Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0, 1, or 2.

  4. Measurable disease by CT/MRI.

  5. Adequate marrow function.

  6. Adequate liver function as indicated by aspartate aminotransferase (AST) alanineaminotransferase (ALT) and serum total bilirubin.

  7. Adequate renal function.

  8. Life expectancy > 6 months.

  9. Signed informed consent and able to comply with the study protocol in theinvestigator's judgment.

  10. Women of childbearing potential must be willing to use a highly effective method ofbirth control for the duration of the study and for ≥ 90 days after the last dose ofstudy drug.

Exclusion

Exclusion Criteria:

  1. Known prolymphocytic leukemia or history of, or currently suspected, Richter'stransformation

  2. Known central nervous system involvement

  3. Received previous systemic treatment for CLL

  4. Clinically significant cardiovascular disease

  5. Severe or debilitating pulmonary disease

  6. History of prior malignancy

  7. Active fungal, bacterial, and/or viral infection requiring systemic therapy

  8. Positive HIV serology (HIVAb) status or serologic status reflecting active hepatitisB or C infection

  9. Uncontrolled autoimmune hemolytic anemia or immune thrombocytopenia requiringtreatment

  10. History of severe bleeding disorder such as hemophilia A, hemophilia B, vonWillebrand disease, or history of spontaneous bleeding requiring blood transfusionor other medical intervention

  11. History of stroke or intracranial hemorrhage ≤ 6 months before the first dose ofstudy treatment

  12. Unable to swallow capsules or tablets or diseases significantly affecting GIfunction

  13. Hypersensitivity to zanubrutinib, sonrotoclax, or any of its excipients

  14. Use of investigational agents within the last 4 weeks before screening

  15. Pregnant and lactating females

Note: Other protocol defined Inclusion/Exclusion criteria may apply

Study Design

Total Participants: 87
Treatment Group(s): 2
Primary Treatment: Sonrotoclax
Phase: 2
Study Start date:
November 14, 2024
Estimated Completion Date:
June 30, 2030

Study Description

This study will test how effective and safe sonrotoclax plus zanubrutinib treatment compared with zanubrutinib alone in participants with previously untreated chronic lymphocytic leukemia (CLL).

The main goals of the study are to determine how many participants may no longer have evidence of cancer or have some improvement in the signs and symptoms of cancer after treatment and to determine what adverse events, or side effects, patients might experience.

Sonrotoclax is an experimental drug that works by blocking a protein called B-cell lymphoma-2 (Bcl-2). This protein helps certain types of blood tumor cells to survive and grow. When sonrotoclax blocks Bcl-2 it slows down or stops the growth of tumor cells and helps them die. This can lead to improvements in patients with CLL disease.

Zanubrutinib is a commercialized product that works by blocking a protein called Bruton's tyrosine kinase (BTK) and controlling the activity and survival of malignant B cells. Zanubrutinib has received approval in over 65 countries/regions worldwide for the treatment of adult participants with B cell malignancies, including CLL.

The study will enroll approximately 87 participants who will be randomly assigned by a computer program to receive one of the following treatments: sonrotoclax + zanubrutinib or zanubrutinib.

The study will take place at multiple centers worldwide. The overall time to participate in this study is approximately 5 years.

Connect with a study center

  • Centro de Pesquisas Oncologicas Cepon

    Florianopolis, 88034-000
    Brazil

    Site Not Available

  • Hospital de Clinicas de Porto Alegre

    Porto Alegre, 900350-903
    Brazil

    Active - Recruiting

  • Hospital de Clinicas de Porto Alegre

    Porto AlegreRS, 900350-903
    Brazil

    Site Not Available

  • Instituto Dor de Pesquisa E Ensino Sao Paulo

    Sao Paulo, 01401-002
    Brazil

    Active - Recruiting

  • Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein

    Sao Paulo, 05653-120
    Brazil

    Active - Recruiting

  • Fujian Medical University Union Hospital

    Fuzhou, Fujian 350001
    China

    Site Not Available

  • Henan Cancer Hospital

    Zhengzhou, Henan 450000
    China

    Site Not Available

  • The First Peoples Hospital of Changzhou

    Changzhou, Jiangsu 213000
    China

    Site Not Available

  • Jiangsu Province Hospital

    Nanjing, Jiangsu 210029
    China

    Site Not Available

  • Rui Jin Hospital Shanghai Jiao Tong University School of Medicine

    Shanghai, Shanghai 200025
    China

    Site Not Available

  • The First Affiliated Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang 310003
    China

    Site Not Available

  • Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia

    Brescia, 25123
    Italy

    Site Not Available

  • Aou Careggi, Servizio Sanitario Toscana

    Firenze, 50134
    Italy

    Site Not Available

  • Universita Degli Studi Di Modena Azienda Ospedaliere Policlinco

    Modena, 41124
    Italy

    Site Not Available

  • Aoor Villa Sofia Cervello

    Palermo, 90146
    Italy

    Site Not Available

  • Pratia Onkologia Katowice

    Katowice, 40-055
    Poland

    Site Not Available

  • Pratia McM Krakow

    Krakow, 30-727
    Poland

    Site Not Available

  • Uniwersytecki Szpital Kliniczny Nr W Lublinie

    Lublin, 20-090
    Poland

    Site Not Available

  • Uniwersytecki Szpital Kliniczny Hematology

    Wroclaw, 50-367
    Poland

    Site Not Available

  • Hospital Clinic de Barcelona

    Barcelona, 8036
    Spain

    Site Not Available

  • Hospital de Cabuenes

    Gijon, 33394
    Spain

    Site Not Available

  • Clinica Universidad de Navarra

    Madrid, 28027
    Spain

    Site Not Available

  • Hospital Universitario Fundacion Jimenez Diaz

    Madrid, 28040
    Spain

    Site Not Available

  • Start Madrid Fundacion Jimenez Diaz

    Madrid, 28040
    Spain

    Site Not Available

  • Clinica Universidad de Navarra Pamplona

    Pamplona, 31008
    Spain

    Site Not Available

  • University of Miami

    Miami, Florida 33136
    United States

    Site Not Available

  • Cleveland Clinic Florida

    Weston, Florida 33331
    United States

    Site Not Available

  • Northwest Georgia Oncology Centers Marietta

    Marietta, Georgia 30060
    United States

    Active - Recruiting

  • Illinois Cancer Specialists (Niles) Usor

    Niles, Illinois 60714
    United States

    Site Not Available

  • University of Maryland Greenebaum Comprehensive Cancer Center

    Baltimore, Maryland 21201
    United States

    Site Not Available

  • Nebraska Cancer Specialists

    Grand Island, Nebraska 68803
    United States

    Active - Recruiting

  • Nebraska Cancer Specialists (Satellite Site)

    Grand Island, Nebraska 68803
    United States

    Active - Recruiting

  • University of Nebraska Medical Center

    Omaha, Nebraska 68198
    United States

    Site Not Available

  • Summit Medical Group

    Florham Park, New Jersey 07932
    United States

    Active - Recruiting

  • New York Cancer and Blood Specialists

    Shirley, New York 11967
    United States

    Site Not Available

  • Oncology Associates of Oregon Willamette Valley Cancer Center

    Eugene, Oregon 97401
    United States

    Site Not Available

  • Texas Oncology Dfw

    Dallas, Texas 96817
    United States

    Site Not Available

  • Texas Oncology Tyler

    Tyler, Texas 75702
    United States

    Site Not Available

  • Utah Cancer Specialists

    Sandy, Utah 08106
    United States

    Site Not Available

  • Northwest Cancer Specialist, Pc(Us Oncology Research)

    Vancouver, Washington 98684
    United States

    Site Not Available

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