A Study to Investigate the Safety of Novel Dose Ramp-up Schedule(s) When Initiating Sonrotoclax in Participants Treated for Blood Cancers.

Launched by BEIGENE · Nov 18, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating a new way to safely start treatment with a medication called sonrotoclax for people with chronic lymphocytic leukemia (CLL), a type of blood cancer. The researchers want to find out if changing the way the medication is given can improve safety for patients who need treatment for this condition. The trial is currently looking for participants between the ages of 65 and 74, who have stable health and specific features in their CLL that require treatment.

To be eligible, participants must have a confirmed diagnosis of CLL and be in good overall health, meaning their organs are functioning well and they have not recently received certain blood treatments. They should also have at least one measurable sign of their disease. Participants can expect to receive the medication and will be monitored closely for any side effects or issues that may arise. It's important to note that individuals who are pregnant, breastfeeding, or planning to become pregnant during the study are not eligible. This study aims to improve the way CLL is treated, making it safer for patients.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Stable ECOG Performance Status ≤ 2.
• • 2. Adequate organ function and no very recent transfusion or blood growth factor
• • 3. Participants of childbearing potential must be willing to use a highly effective method of birth control and refrain from egg donation for the duration of the study and for ≥ 90 days after the last dose of sonrotoclax or ≥ 30 days after the last dose of zanubrutinib, whichever is later.
• • 4. Confirmed diagnosis of CLL, based on Hallek et al 2018, and requiring treatment due to certain features of their disease
• • 5. At least 1 measurable lesion based on computed tomography (CT)/magnetic resonance imaging (MRI) and no history of prolymphocytic leukemia or Richter's transformation.
• Exclusion Criteria:
• • 1. Participants unable to comply with the requirements of the protocol
• • 2. Serologic status reflecting active viral HBV or HCV infection
• • 3. Positive HIV serology (HIVAb) status unless certain conditions are met.
• • 4. Participants with any major surgical procedure ≤ 28 days before first dose of study treatment
• • 5. Prior systemic treatment for the CLL
• • 6. Uncontrolled autoimmune hemolytic anemia or immune thrombocytopenia requiring treatment
• • NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.