A Randomized Phase 3 Trial of Continuous vs. Intermittent Maintenance Therapy With Zanubrutinib as Upfront Treatment in Older Patients With Mantle Cell Lymphoma
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What is the purpose of 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 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.
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Principal Investigator
Sub-Investigators
- Agatha Hecht
- Alexis Walker
- Alfredo Axtmayer
- Alison Johnson
- Anca Bulgaru, MD
- Andrea Brennan
- Andrea Silber, MD
- Armand Russo, MD
- Ashita Talsania, MRCP, MBBS
- Benjamin Newton, MD
- Beverly Drucker, MD, PhD
- Brooke Chaves
- Catherine Wei, MD
- D. Barry Boyd, MD, MS
- David Witt, MD
- Elan Gorshein, DO, JD, MPH
- Emily Kopas, APRN, OCN
- Ethan Kohn
- Francesca Montanari, MD
- Francine Foss, MD
- Harold Tara Jr, MD
- Iris Isufi, MD
- James Vredenburgh, MD
- Jane Kanowitz, MD
- Jason Haldas, MD
- Jean Vollmer
- Jeremy Kortmansky, MD
- Johanna LaSala, MD
- Jose Morales-Marin
- Justin Persico, MD
- Kaitlin Brown
- Karen Ann Hammond, DNP, APRN, ACNP (BC)
- Katherine Harvey, MD, MPH
- Kathleen Fenn, MD
- Kert Sabbath, MD, FACP
- Kristen Hoxie
- Larisa Fleysher
- Laura Sabourin
- Leena Rahmat
- M. Sung Lee, MD
- Madeline Santiago
- Matthew Austin, MD
- Michael Cohenuram, MD
- Michael Grant, MD
- Neal Fischbach, MD
- Nicholas Blondin, MD
- Renee Moye
- Robert Legare, MD
- Sara Anastasio, RN
- Sarah Carlson
- Sarah Thomen, APRN
- Scott Huntington, MD, MPH, MSc
- Sharynn Hall, MD, PhD
- Stacey LaRosa
- Stephen Lattanzi, MD
- Stuart Seropian, MD
- Su Hsien Lim, MD
- Sudhanshu Mulay, MD
- Syed Ali
- Syed Bilgrami, MBBS
- Tarsheen Sethi, MD, MSc
- Victor Chang, MD
- Vidya Kesavan
- Virginia Syombathy
- Wajih Kidwai, MD, FACP
- Yifei Zhang, MD
- Last Updated11/14/2024
- Study HIC#2000036380