Study of Zanubrutinib in Older Patients With Previously Untreated Chronic Lymphocytic Leukemia (CLL)

Sponsor
The Lymphoma Academic Research Organisation
Study ID
NCT07739459
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
80 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Zanubrutinib — DRUG
    Zanubrutinib is a Bruton tyrosine kinase (BTK) inhibitor administered orally.

Study Details

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.

Key Dates

First listed
Jul 31, 2026
Start date
Dec 31, 2026
Status verified
Jul 2026
Primary completion
Apr 30, 2029
Completion
Dec 31, 2032

Study Design

Enrollment
95 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Zanubrutinib
    Participants will receive oral zanubrutinib followed by a predefined dose reduction strategy. Treatment will continue until disease progression, permanent treatment discontinuation, withdrawal of consent, loss to follow-up, or the end of study participation.

Primary Outcome Measure

Progression-Free Survival (PFS) [ Time Frame: 30 months and 5 years ]

Central Contacts

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