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

Description

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.

Conditions

Chronic Lymphocytic Leukemia

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Chronic Lymphocytic Leukemia
Intervention / Treatment

-

Contacts and Locations

Miami

University of Miami, Miami, Florida, United States, 33136

Weston

Cleveland Clinic Florida, Weston, Florida, United States, 33331

Marietta

Northwest Georgia Oncology Centers Marietta, Marietta, Georgia, United States, 30060

Baltimore

University of Maryland Greenebaum Comprehensive Cancer Center, Baltimore, Maryland, United States, 21201

Grand Island

Nebraska Cancer Specialists (Satellite Site), Grand Island, Nebraska, United States, 68803

Grand Island

Nebraska Cancer Specialists, Grand Island, Nebraska, United States, 68803

Omaha

University of Nebraska Medical Center, Omaha, Nebraska, United States, 68198

Florham Park

Summit Medical Group, Florham Park, New Jersey, United States, 07932

Sandy

Utah Cancer Specialists, Sandy, Utah, United States, 08106

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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) alanine aminotransferase (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 the investigator's judgment.
  • 10. 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.
  • 1. Known prolymphocytic leukemia or history of, or currently suspected, Richter's transformation
  • 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 hepatitis B or C infection
  • 9. Uncontrolled autoimmune hemolytic anemia or immune thrombocytopenia requiring treatment
  • 10. 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
  • 11. History of stroke or intracranial hemorrhage ≤ 6 months before the first dose of study treatment
  • 12. Unable to swallow capsules or tablets or diseases significantly affecting GI function
  • 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

BeiGene,

Study Director, STUDY_DIRECTOR, BeiGene

Study Record Dates

2030-06