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

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorBeOne Medicines

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

Qualifiers

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

Treatments tested in this trial

  • Sonrotoclax
  • Zanubrutinib

Treatment groups

258 Participants
are divided into 2 treatment groups

Sponsors and collaborators