Testing Continuous Versus Intermittent Treatment With the Study Drug Zanubrutinib for Older Patients With Previously Untreated Mantle Cell Lymphoma

Recruiting Phase 3 Interventional Study
Mantle Cell Lymphoma
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
60 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
421 (estimated)
Sponsor
Alliance for Clinical Trials in Oncology · Other
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About This Trial
This phase III trial tests whether continuous or intermittent zanubrutinib after achieving a complete remission (CR) with rituximab works in older adult patients with mantle cell lymphoma (MCL) who have not received treatment in the past (previously untreated). Rituximab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Zanubrutinib may stop the growt…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * • Histologically confirmed mantle cell lymphoma with cyclin D1 (BCL1) expression by immunohistochemical stains and/or evidence of CCND1 rearrangement or t(11;14)(q13;q32) as confirmed by the enrolling center (such as by fluorescence in situ hybridization \[FISH\], polymerase c…
Contacts

Anne Beaven, MD

919-966-9268

anne_beaven@med.unc.edu

CONTACT

Destin Carlisle

773-702-8824

dcarlisle@bsd.uchicago.edu

CONTACT