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

Sponsored by BeiGene

About this trial

Last updated 8 months ago

Study ID

BGB-11417-108

Status

Not yet recruiting

Type

Interventional

Phase

Phase 1/Phase 2

Placebo

No

Accepting

18-75 Years
18+ Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Started 7 months ago

What is this trial about?

The purpose of this study is to establish the safety of novel dosing and ramp-up schedules for sonrotoclax in participants with hematological malignancies.

What are the participation requirements?

Yes

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.

No

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.