At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Sonrotoclax (drug), Zanubrutinib (drug)
- How long the study runs
- Study runs about 94 months (dates as stated)
- About the drug or intervention
- Sonrotoclax — drug: Administered orally · Zanubrutinib — drug: Administered orally
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 258
- Started
- 2025-01-23
- Last checked
- 2026-09
Plain English Summary
What is this study?
- • Testing a new treatment for chronic lymphocytic leukemia
- • Phase1/Phase2 - 258 participants
- • The purpose of this study is to establish the safety of novel dosing and ramp-up schedules for sonrotoclax in participants with hematological malignancies
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with chronic lymphocytic leukemia
Where?
- • Birmingham - Queen Elizabeth Hospital
- • Leeds - St Jamess University Hospital
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
The purpose of this study is to establish the safety of novel dosing and ramp-up schedules for sonrotoclax in participants with hematological malignancies.
More detail
This study will test the safety of novel sonrotoclax dosing with gradual increases of sonrotoclax dose over specified periods until the intended target daily dose is reached. The focus will be on tumor lysis syndrome (TLS) and related toxicity signals. Sonrotoclax is a drug that works by blocking a protein called B-cell lymphoma-2 (BCL-2). When sonrotoclax blocks BCL-2 it slows down or stops the growth of tumor cells and helps them die. This can lead to improvements in patients with certain malignant diseases including chronic lymphocytic leukemia (CLL) and mantle cell lymphoma (MCL). The start of treatment with BCL-2 inhibitor requires a gradual ramp-up over the first weeks to avoid potential consequences of initial tumor cell breakage and the release of cell content in the bloodstream. Several ramp-up schedules have already been explored, and this study aims to optimize the dosing ramp-up schedule that may be beneficial to patients and caregivers. Zanubrutinib is a commercialized product that works by blocking a protein called Bruton's tyrosine kinase (BTK) and controlling the activity and survival of malignant B cells. Zanubrutinib has received approval in over 65 countries/regions worldwide for the treatment of adult participants with B-cell malignancies, including CLL and MCL. This study will take place at multiple centers worldwide. The overall time to participate in this study is approximately 17 months for treatment-naïve (TN) CLL participants or approximately 32 months for relapsed/refractory (R/R) MCL participants.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
Biomarkers mentioned
Treatment history
Treatments you must have had:
- ✓ of systemic therapy
What the study is looking for
- ✓Stable activity scale (ECOG) Performance Status ≤ 2.
- ✓healthy organ and no very recent transfusion or blood growth factor
- ✓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...
Who cannot take part
- ✗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
See the full criteria
Where Is This Study? (2 UK sites)
Queen Elizabeth Hospital
Birmingham B15 2TH, United Kingdom
St Jamess University Hospital
Leeds LS9 7TF, United Kingdom
How to Get in Touch
Study Director
Sponsor contactCONTACT
Study Director
Sponsor contactCONTACT
