Zanubrutinib and Venetoclax as Initial Therapy for Chronic Lymphocytic Leukemia (CLL) With Response-based Obinutuzumab

Launched by WEILL MEDICAL COLLEGE OF CORNELL UNIVERSITY · Dec 6, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new way to treat patients with chronic lymphocytic leukemia (CLL) using two oral medications, zanubrutinib and venetoclax. The researchers believe that instead of giving a third drug (obinutuzumab) to everyone right away, it might be better to reserve it for patients who still have detectable cancer in their blood after initial treatment. This approach aims to reduce unnecessary treatment and side effects while enhancing the effectiveness of the anti-CD20 therapy for those who need it.

To participate in this trial, individuals must have a confirmed diagnosis of CLL and need treatment. They should not have received prior cancer therapies for CLL and must meet other specific health criteria. Participants can expect to receive zanubrutinib alone for the first part of the trial, followed by a combination of zanubrutinib and venetoclax. If their cancer is no longer detectable after this combination treatment, they will enter a monitoring phase. However, if some cancer remains, they will receive additional treatments with both zanubrutinib and venetoclax, along with obinutuzumab, to help improve their response. This study is currently recruiting participants aged 65 and older and welcomes individuals of all genders.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Participant must have confirmed diagnosis of CLL/SLL
• • Participant must have indications for treatment
• • Participants of childbearing potential must be willing to comply with pregnancy prevention interventions
• Exclusion Criteria:
• • Previous exposure to any systemic anti-cancer therapy as a treatment for CLL/SLL, including but not limited to chemotherapy, immunotherapy, radiotherapy, hormone therapy (other than contraceptives, hormone-replacement therapy or megestrol acetate) or investigational therapy.
• • History of malignancy except for non-melanoma skin cancers. Participants treated with curative intent via methods of local resection and or locally targeted anticancer treatment and are free of malignancy for at least 5 years from treatment end will be allowed to enroll.
• • Requires chronic immunosuppressive therapy for any reason or was treated with immunosuppressive therapy within 6 months of study entry.
• • Participants with active autoimmune hemolytic anemia or immune thrombocytopenia purpura.
• • Prolymphocytic leukemia or Richter's Transformation.
• • Active bleeding, or history of bleeding diathesis (e.g., hemophilia or von Willebrand disease).
• • Participant requires warfarin or equivalent vitamin K antagonist.
• • Uncontrolled or active significant infection requiring systemic treatment
• • History of suspected or confirmed PML
• • Myocardial infarction within 6 months before screening.
• • Unstable angina within 3 months before screening.
• • New York Heart Association class III or IV congestive heart failure
• • History of clinically significant arrhythmias (eg, sustained ventricular tachycardia, ventricular fibrillation, torsades de pointes).
• • Patients with stroke or CNS hemorrhage within 6 months.
• • Pregnant or breastfeeding.
• • Major surgical procedure within 28 days of first dose of study drug.
• • Has difficulty with or is unable to swallow oral medication or has significant gastrointestinal disease that would limit absorption of oral medication.
• • Participant is positive for human immunodeficiency virus (HIV).
• • Known hypersensitivity reactions (e.g., anaphylaxis) to obinutuzumab or any of the excipients, including serum sickness with prior obinutuzumab use.
• • Vaccination with live vaccine ≤28 days prior to start of treatment.

Trial Officials