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

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 growth of cancer cells by blocking some of the enzymes needed for cell growth. When zanubrutinib is used in MCL, the current standard of care is to continue administering the drug indefinitely until diseas

Trial Details

NCT ID
NCT05976763
Phase
PHASE3
Sponsor
Alliance for Clinical Trials in Oncology
Status
RECRUITING
Cancer Type
Non-Hodgkin Lymphoma Lymphoma
Interventions
  • Zanubrutinib
  • Rituximab
  • Patient Observation
  • Bone Marrow Biopsy
  • Fludeoxyglucose F-18
  • Positron Emission Tomography
Locations (sample)
  • Little Rock, Arkansas, United States|34.74648,-92.28959
  • Beverly Hills, California, United States|34.07362,-118.40036
  • Duarte, California, United States|34.13945,-117.97729
  • Irvine, California, United States|33.66946,-117.82311
  • Los Angeles, California, United States|34.05223,-118.24368

Key Eligibility Criteria

  • • Histologically confirmed mantle cell lymphoma with cyclin D1 (BCL1) expression by immunohistochemical stains and/or evidence of CCND1 rearrangeme…
  • Any stage allowed (stage I-IV)
  • Patient must have at least one objective measurable disease parameter by PET or CT. Measurable disease in the liver is required if the liver is the…
  • Steroids for management of mantle cell lymphoma are allowed up to a dose of prednisone 100mg/day (or equivalent) for up to 7 days prior to registra…

For full eligibility, visit ClinicalTrials.gov.

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