This phase II, open-label, multicenter study evaluates zanubrutinib in patients aged 80 years and older with previously untreated chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who require treatment.
CLL and SLL are slow-growing blood cancers that mainly affect older adults. Although zanubrutinib is an effective treatment, taking it continuously at the full dose may increase the risk of side effects over time, particularly in elderly patients. The study aims to assess whether a planned reduction in the dose of zanubrutinib after an initial period of treatment can maintain disease control while improving long-term tolerability.
Participant who understands and voluntarily signs and dates an informed consent form prior to any studyspecific assessments/procedures being conducted, including consent for specific biology analysis
Must be able to adhere to the trial visit schedule and other protocol requirements
≥ 80 years at the time of signing the informed consent form (ICF) with no upper age limit
Previously untreated and documented CLL or small lymphocytic lymphoma (SLL), with a Royal Marsden Hospital (RMH) or Matutes Score of 4 or 5. For SLL a detectable clone with a CLL phenotype in the peripheral blood is a prerequisite for trial participation.
Any prior CLL or SLL-specific therapies, even including rituximab used for autoimmune cytopenias.
Myocardial infarction within 6 months prior to ICF signature
Unstable angina within 3 months prior to ICF signature
NYHA class III or IV heart failure
Single group
Zanubrutinib
DrugZanubrutinib is a Bruton tyrosine kinase (BTK) inhibitor administered orally.
Progression-Free Survival (PFS)
The primary endpoint is the Progression-Free Survival (PFS).
Permanent Treatment Discontinuation (PTD) Rate
The key secondary endpoint is the rate of permanent treatment discontinuation (PTD).
Overall Survival (OS)
The secondary efficacy endpoint 1 is the Overall Survival (OS).
Time to Next Anti-Leukemia Treatment
The secondary efficacy endpoint 2 is the Time to Next Anti-Leukemia Treatment (TTNLT).
Overall Response Rate
The secondary efficacy endpoints 3 and 4 are Overall Response Rate (ORR) at 18 months and at 30 months, respectively.
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The Lymphoma Academic Research Organisation
Lead sponsor
Lymphoma Study Association
Collaborator
BeOne Medicines
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
