2026-06-05
notable
Active, Not Recruiting→Recruiting Study Identification, Study Status, Sponsor/Collaborators, Study Description, Conditions, Study Design, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations, IPDSharing v14
Trial statusActive, Not Recruiting→Recruiting
Primary completion date2027-06→2029-11-30
Completion date2027-12-31→2032-11-30
Enrollment target56→258
Lead sponsorBeiGene→BeOne Medicines
Eligibility criteria+910 characters
Inclusion Criteria:
Stable Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2.
Adequate organ function and no very [...] n from egg donation for the duration of the study and for ≥ 907 days after the last dose of sonrotoclax or ≥1 30 daysmonth after the last dose of zanubrutinib, whichever is later.
Only for participants with Chronic Lymphocytic Leukemia (CLL):
Confirmed diagnosis of CLL, based on Hallek et al 2018, and [...] ory of prolymphocytic leukemia or Richter's transformation.
Only for participants with Mantle cell lymphoma (MCL):
Historically confirmed diagnosis of MCL based on the W [...] [...]
Secondary endpointsdetails revised at 2 of 2 entries
Study description-361 characters
[...] on tumor lysis syndrome (TLS) and related toxicity signals.
In the first part of the study, each ramp-up dosing schedule will first be tested in a small group of approximately 5 to 6 participants to assess safety and establish if the schedule is suitable for further testing in additional participants (schedule calibration).
In the second part of the study, a [...] Sonrotoclax is an experimentala drug that works by blocking a protein called B-cell lymphoma-2 (BCL-2).
This protein helps certain types of blood tumor cells to survive and grow.
When sonrotoclax blocks BclBCL-2 it slows down or stops the g [...] [...]
Study sitesdetails revised at 17 of 17 sites
2025-12-15
notable
Recruiting→Active, Not Recruiting Study Status, Contacts/Locations v13
Trial statusRecruiting→Active, Not Recruiting
Study sitesdetails revised at 17 of 17 sites
Show 11 earlier versions
2025-09-23
minor
Study Status, Contacts/Locations v11
2025-09-12
minor
Study Status, Contacts/Locations v10
Study sitesdetails revised at 1 of 19 sites
2025-08-19
minor
Study Status, Contacts/Locations v9
Study sitesdetails revised at 6 of 19 sites
2025-07-24
minor
Study Status, Contacts/Locations v8
Study sitesdetails revised at 3 of 19 sites
2025-07-11
minor
Study Status, Contacts/Locations v7
Study sitesdetails revised at 2 of 19 sites
2025-06-05
minor
Study Status, Contacts/Locations v6
2025-04-30
minor
Study Status, Contacts/Locations v5
Study sitesdetails revised at 10 of 20 sites
2025-03-24
minor
Study Status, Contacts/Locations v4
2025-02-17
minor
Study Status, Contacts/Locations, IPDSharing v3
Study sites19 entries, revised
Washington University School of Medicine
2025-01-30
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2025-01-31→confirmed 2025-01-23
Study sites10→19
2025-01-14
minor
Study Status, Contacts/Locations v1
Start date2024-12-15→2025-01-31
Study sites0→10