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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.

StatusRecruiting
PhasePhase 1/2
Started2025-01-23
View on ClinicalTrials.gov ↗

Amendment history

2026-09-29
minor
Trial sites expanded: 17 → 20 locations
2026-08-06
minor
Study Status, Contacts/Locations v15
Study sitesdetails revised at 11 of 17 sites
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
2025-10-23
minor
Study Identification, Study Status, Contacts/Locations v12
Study sites16→17
Show 11 earlier versions
2025-09-23
minor
Study Status, Contacts/Locations v11
Study sites19→16
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
Study sites20→19
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
Study sites19→20
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
2024-11-18
minor
Original filing
The purpose of this study is to establish the safety of novel dosing and ramp-up schedules for sonrotoclax in participants with hematological malignancies.
Trial Details
NCT Number NCT06697184
Lead Sponsor BeOne Medicines
Conditions Chronic Lymphocytic Leukemia, CLL, Mantle Cell Lymphoma, MCL
Enrollment 258 participants
Start Date 2025-01-23
Primary Completion 2029-11-30 (estimated)
Study Completion 2032-11-30 (estimated)
Updated on ClinicalTrials.gov 2026-09-28