Actively Recruiting
A Phase 1/2 Study to Investigate Safety of Sonrotoclax Dose Ramp-up in Adults With Hematological Malignancies
Led by BeOne Medicines · Updated on 2026-06-08
258
Participants Needed
17
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety of new dosing and ramp-up schedules for sonrotoclax in adults with hematological cancers such as chronic lymphocytic leukemia (CLL) and mantle cell lymphoma (MCL). The study focuses on monitoring tumor lysis syndrome (TLS) and related toxicities during the gradual increase of sonrotoclax doses. This phase 1/2 open-label study aims to optimize dosing schedules to potentially improve patient outcomes. Participants receive zanubrutinib alone initially, followed by a combination of zanubrutinib and sonrotoclax, with sonrotoclax doses gradually increased according to specific schedules outlined in the protocol. Treatment duration varies by cancer type: about 15 cycles of 28 days for treatment-naïve CLL participants, and 27 cycles of 28 days for relapsed or refractory MCL participants, after which some continue zanubrutinib alone until disease progression or other criteria are met. During the study, participants will be closely monitored for TLS and other adverse events up to approximately four months. Assessments include safety evaluations, dose modifications, and regular clinical visits. The total participation time is approximately 17 months for treatment-naïve CLL patients and about 32 months for relapsed/refractory MCL patients, ensuring thorough follow-up and safety monitoring.
CONDITIONS
Brief Title
A Study to Investigate the Safety of Novel Dose Ramp-up Schedule(s) When Initiating Sonrotoclax in Participants Treated for Blood Cancers.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Stable Eastern Cooperative Oncology Group (ECOG) Performance Status of 2 or less
- Adequate organ function with no recent transfusion or blood growth factor
- Willingness to use effective birth control and avoid egg donation during and shortly after treatment if of childbearing potential
- Confirmed diagnosis of chronic lymphocytic leukemia (CLL) requiring treatment, with at least one measurable lesion and no history of prolymphocytic leukemia or Richter's transformation (for CLL participants)
- Confirmed diagnosis of mantle cell lymphoma (MCL) per WHO or ICC classification
- Relapsed or refractory MCL after at least one prior systemic therapy line, with measurable disease
You will not qualify if you...
- Inability to comply with study protocol requirements
- Active hepatitis B or C infection
- Positive HIV serology unless specific conditions are met
- Major surgery within 28 days before first study dose
- Prior systemic treatment for CLL
- Uncontrolled autoimmune hemolytic anemia or immune thrombocytopenia requiring treatment
- Previous exposure to a BCL-2 inhibitor
- Other protocol-defined exclusion criteria may apply
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 15 cycles of 28 days (about 17 months) for treatment-naïve CLL participants; Approximately 27 cycles of 28 days (about 32 months) for relapsed/refractory MCL participants, then continued zanubrutinib alone until disease progression or discontinuation
Participants receive zanubrutinib alone, followed by combination treatment with sonrotoclax with a gradual dose ramp-up to reach the target dose. Treatment cycles last 28 days each, with a total of 15 cycles for treatment-naïve CLL participants or 27 cycles for relapsed/refractory MCL participants. After 27 cycles, MCL participants continue zanubrutinib alone until disease progression or treatment discontinuation.
Regular visits according to protocol during treatment cycles
Trial Site Locations
Total: 17 locations
1
Moffitt Cancer Center
Tampa, Florida, United States, 33612-9496
Active, Not Recruiting
2
Fort Wayne Medical Oncology and Hematology
Fort Wayne, Indiana, United States, 46804
Active, Not Recruiting
3
The University of Kansas Cancer Center
Westwood, Kansas, United States, 66205-2003
Active, Not Recruiting
4
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215-5418
Active, Not Recruiting
5
Washington University School of Medicine
St Louis, Missouri, United States, 63110-1010
Active, Not Recruiting
6
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109-4433
Active, Not Recruiting
7
Blacktown Cancer and Haematology Centre
Blacktown, New South Wales, Australia, NSW 2148
Actively Recruiting
8
Genesiscare St Andrews
Adelaide, South Australia, Australia, SA 5000
Actively Recruiting
9
Cabrini Hospital Malvern
Malvern, Victoria, Australia, VIC 3144
Actively Recruiting
10
The Alfred Hospital
Melbourne, Victoria, Australia, VIC 3004
Actively Recruiting
11
Rockingham Hospital
Cooloongup, Western Australia, Australia, WA 6168
Actively Recruiting
12
Linear Clinical Research
Nedlands, Western Australia, Australia, WA 6009
Actively Recruiting
13
Chu Dijon
Dijon, France, 21000
Active, Not Recruiting
14
Chu Montpellier Hopital Saint Eloi
Montpellier, France, 34090
Active, Not Recruiting
15
Iuct Oncopole
Toulouse, France, 31100
Active, Not Recruiting
16
Queen Elizabeth Hospital
Birmingham, United Kingdom, B15 2TH
Active, Not Recruiting
17
St Jamess University Hospital
Leeds, United Kingdom, LS9 7TF
Active, Not Recruiting
Research Team
S
Study Director
S
Study Director
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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