About this trial
The purpose of this study is to establish the safety of novel dosing and ramp-up schedules for sonrotoclax in participants with hematological malignancies.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Stable Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2.
Adequate organ function and no very recent transfusion or blood growth factor
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 ≥ 7 days after the last dose of sonrotoclax or 1 month after the last dose of zanubrutinib, whichever is later.
Confirmed diagnosis of CLL, based on Hallek et al 2018, and requiring treatment due to certain features of their disease
Disqualifiers
Participants unable to comply with the requirements of the protocol
Serologic status reflecting active viral hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
Positive HIV serology (HIVAb) status unless certain conditions are met.
Participants with any major surgical procedure ≤ 28 days before first dose of study treatment
Trial design
Sequential
Treatments tested in this trial
Sonrotoclax
DrugAdministered orally
Zanubrutinib
DrugAdministered orally
Treatment groups
Trial outcomes
Primary outcomes
Number of Participants who Experience Tumor Lysis Syndrome (TLS)
TLS will be defined by Howard criteria during the schedule-limiting toxicity (SLT) evaluation window
Secondary outcomes
Number of Participants with Adverse Events (AEs)
Safety will be assessed by monitoring and recording of all treatment emergent adverse events (AEs) graded by National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0 and tolerability as determined by protocol-defined Cs during the SLT evaluation window
Number of Participants with Dose Modifications During the SLT Evaluation Window
Sponsors and contacts
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