Tests safety of new sonrotoclax dose schedules in blood cancers
Tests safety of new sonrotoclax dosing schedules in adults with leukemia or lymphoma.
Key facts
- Who runs it
- BeOne Medicines
- Where
- Boston, Fort Wayne, Seattle, St Louis, Tampa, and Westwood, United StatesSee the 6 sitesAlso in 7 other countries, 22 sites
- Trial code
- Registry title
- A Study to Investigate the Safety of Novel Dose Ramp-up Schedule(s) When Initiating Sonrotoclax in Participants Treated for Blood Cancers.
- Status
- Recruiting
- Phase
- Phase 1/2
- People taking part
- 258 people, planned
- Started
- 23 Jan 2025
- Expected to end
- 30 Nov 2032
- Type of study
- Interventional, 2 groups
- Treatments tested
- Sonrotoclax
- Zanubrutinib
- Record updated
- 26 October 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with chronic lymphocytic leukemia (CLL) or mantle cell lymphoma (MCL) to test the safety of new ways to start the drug sonrotoclax.
- Age
- 18 years or older
- Sex
- All sexes can join.
- Disease stage
- CLL: confirmed diagnosis that needs treatment, with at least 1 measurable lesion on CT or MRI. MCL: confirmed diagnosis that came back or did not respond to the last treatment, with measurable disease.
- Earlier treatment
- CLL: no earlier systemic treatment for CLL. MCL: at least 1 earlier line of systemic therapy. People who had a BTK inhibitor must not have progressed during it or relapsed within 12 months after stopping it. No earlier BCL-2 inhibitor.
Main reasons for not taking part
- Active hepatitis B or hepatitis C infection
- Positive HIV test, unless certain conditions are met
- Major surgery within 28 days before the first dose
- Uncontrolled autoimmune hemolytic anemia or immune thrombocytopenia needing treatment
- Earlier treatment with a BCL-2 inhibitor
The registry criteria, word for word
Show all 15 criteriaShow less
Who can take part
- 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
Who cannot take part
- Participants with any major surgical procedure ≤ 28 days before first dose of study treatment
- Prior systemic treatment for the CLL
- Prior exposure to a BCL-2 inhibitor; NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
- 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
- Uncontrolled autoimmune hemolytic anemia or immune thrombocytopenia requiring treatment
- Participants unable to comply with the requirements of the protocol
Where in United States
Also in 7 other countries, 22 sites
- Dana-Farber Cancer InstituteBoston, United StatesContact: Study DirectorTaking people
- Fort Wayne Medical Oncology and HematologyFort Wayne, United StatesContact: Study DirectorTaking people
- Fred Hutchinson Cancer Research CenterSeattle, United StatesContact: Study DirectorTaking people
- Washington University School of MedicineSt Louis, United StatesContact: Study DirectorTaking people
- Moffitt Cancer CenterTampa, United StatesContact: Study DirectorTaking people
- The University of Kansas Cancer CenterWestwood, United StatesContact: Study DirectorTaking people
About the trial
What the trial wants to find out
The purpose of this study is to establish the safety of novel dosing and ramp-up schedules for sonrotoclax in participants with hematological malignancies.
The 2 groups in the trial
- Arms: 1A,1B and 2A: Zanubrutinib + Sonrotoclax for TN CLLTreatment being tested
Participants will receive zanubrutinib alone, followed by a combination with sonrotoclax initiated with a ramp-up according to each schedule defined in the protocol. The total treatment duration is of 15 cycles of 28 days (including the phase of sonrotoclax dose ramp-up)
Treatment: Sonrotoclax and Zanubrutinib
- Arms: 1C and 2B: Zanubrutinib + Sonrotoclax for R/R MCLTreatment being tested
Participants will receive zanubrutinib alone, followed by a combination with sonrotoclax initiated with a ramp-up according to each schedule defined in the protocol, for a total of 27 cycles of 28 days (including the phase of sonrotoclax ramp-up), then will continue on zanubrutinib alone until progression of their disease or other treatment discontinuation criteria.
Treatment: Sonrotoclax and Zanubrutinib
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
- Official title
- A Phase 1/2 Open-label Study to Investigate the Safety of Sonrotoclax Ramp-up Schedule(s) in Adult Patients With Hematological Malignancies.
- Plain-language title
- Tests safety of new sonrotoclax dose schedules in blood cancersGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 14 November 2026.
- Record updated
- 26 October 2026