A Study to Investigate the Safety of Novel Dose Ramp-up Schedule(s) When Initiating Sonrotoclax in Participants Treated for Blood Cancers.
Recruiting now · Phase 1/Phase 2
Conditions studied: Chronic Lymphocytic Leukemia, CLL, Mantle Cell Lymphoma, MCL
In brief
The purpose of this study is to establish the safety of novel dosing and ramp-up schedules for sonrotoclax in participants with hematological malignancies.
Key facts
- Study ID
- NCT06697184
- Run by
- BeOne Medicines
- People needed
- 258
- Starts
- 2025-01-23
- Expected to finish
- 2032-11-30
- Last updated by the study team
- 2026-06-08
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
- Only for participants with Chronic Lymphocytic Leukemia (CLL):
- Confirmed diagnosis of CLL, based on Hallek et al 2018, and requiring treatment due to certain features of their disease
- At least 1 measurable lesion based on computed tomography (CT)/magnetic resonance imaging (MRI) and no history of prolymphocytic leukemia or Richter's transformation.
- Only for participants with Mantle cell lymphoma (MCL):
- Historically confirmed diagnosis of MCL based on the World Health Organization 2022 classification of Haematolymphoid Tumors (WHO-HEAM5) or based on International Consensus Classification (ICC).
- Relapsed or refractory to the last line of therapy and have received at least 1 prior line of systemic therapy. Note: A line of therapy is considered ≥ 2 consecutive cycles of a systemic anticancer regimen. Patients with prior BTKi therapy should not have progressed during treatment or relapsed within 12 months after BTKi discontinuation.
- Measurable disease defined as ≥ 1 nodal lesion that is > 1.5 cm in longest diameter, or ≥ 1 extranodal lesion that is > 1 cm in longest diameter.
You may not qualify if…
- 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
- Prior systemic treatment for the CLL
- Uncontrolled autoimmune hemolytic anemia or immune thrombocytopenia requiring treatment
- Prior exposure to a BCL-2 inhibitor
- NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Where it is running
- Linear Clinical Research — Nedlands, Western Australia, Australia (enrolling)
- Blacktown Cancer and Haematology Centre — Blacktown, New South Wales, Australia (enrolling)
- Genesiscare St Andrews — Adelaide, South Australia, Australia (enrolling)
- Cabrini Hospital Malvern — Malvern, Victoria, Australia (enrolling)
- The Alfred Hospital — Melbourne, Victoria, Australia (enrolling)
- Rockingham Hospital — Cooloongup, Western Australia, Australia (enrolling)
- Chu Dijon — Dijon, France
- Chu Montpellier Hopital Saint Eloi — Montpellier, France
- Iuct Oncopole — Toulouse, France
- Queen Elizabeth Hospital — Birmingham, United Kingdom
- Moffitt Cancer Center — Tampa, Florida, United States
- St Jamess University Hospital — Leeds, United Kingdom
- Fort Wayne Medical Oncology and Hematology — Fort Wayne, Indiana, United States
- The University of Kansas Cancer Center — Westwood, Kansas, United States
- Dana Farber Cancer Institute — Boston, Massachusetts, United States
- Washington University School of Medicine — St Louis, Missouri, United States
- Fred Hutchinson Cancer Research Center — Seattle, Washington, United States
Full record on ClinicalTrials.gov
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