A Randomized Phase 3 Trial of Continuous vs. Intermittent Maintenance Therapy With Zanubrutinib as Upfront Treatment in Older Patients With Mantle Cell Lymphoma

Summary

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 disease progression. This continuous treatment comes with clinical as well as financial toxicity, which could be especially detrimental in older patients. For patients who achieve a CR after initial zanubrutinib plus rituximab therapy, it may be safe and equally effective to stop treatment and restart zanubrutinib upon disease progression rather than continuing indefinitely in previously untreated older adult patients with MCL.

Description

Eligibility

Age range

60+ years

Sex

All

Healthy volunteers

No

Interventions

• Drug
  Zanubrutinib

  Given PO

• Biological
  Rituximab

  Given IV

• Other
  Patient Observation

  Undergo observation

• Procedure
  Bone Marrow Biopsy

  undergo bone marrow biopsy

• Other
  Fludeoxyglucose F-18

  Given IV

• Procedure
  Positron Emission Tomography

  Undergo PET

• Procedure
  Computed Tomography

  Undergo CT

Locations (236)