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Testing Continuous Versus Intermittent Treatment With the Study Drug Zanubrutinib for Older Patients With Previously Untreated Mantle Cell Lymphoma [A052101]

This study is being done to determine whether older adult patients diagnosed with mantle cell lymphoma require continuous treatment with the study drug zanubrutinib once remission has been retained.

Age & Gender

  • 60 years ~ 99 years
  • Male, Female, Gender Inclusive

Visit Availability

  • Standard business hours (M-F, 8-5)

Location

United States (Nationwide)

What will be asked of you

If you achieve complete remission after 6 28-day cycles of rituximab and zanubrutinib, you will be randomized to arm A, and continue to receive zanubritinib indefinitely, or arm B, and only receive zanubritinib once your mantle cell lymphoma progresses. During the study, you will record when you take zanubritinib in a drug diary. You will receive the same scans and bloodwork as the standard of care treatment for mantle cell lymphoma. You will be asked if you want to participate in optional studies. Some of these studies are questionnaires looking at the social determinants of health and your quality of life before, during and after treatment. Some will be looking at donating blood and tissue for future research studies. After treatment, you will be expected to attend follow-up appointments every 6 months.

Incentives

You or your insurance will not have to pay for the study drug zanubruinib.

In-person visits:
9-30
Total length of participation:
6 months for up to 10 years of follow up

Looking for Specific Volunteers

Able to participate:

  • You have mantle cell lymphoma at any stage (I-IV)
  • You are over the age of 60.
  • You have not had any prior treatment for mantle cell lymphoma

Not eligible if:

  • You have previously been treated with a BTK inhibitor or anti-CD20 monoclonal antibody
  • You have had a stem cell transplant
  • You have significant heart disease.
  • You have an active HIV Hepatitis B or Hepatitis C infection with a detectable viral load

Contact the Team

Visit Location

Contact & Visit Location

Primary Contact

Primary Visit Location

Lineberger Comprehensive Cancer Center
NC Cancer Hospital (Basnight)
UNC Hospitals / UNC Medical Center
101 Manning Dr, Chapel Hill, NC 27514, USA

Additional Study Information

Principal Investigator

Anne Beaven
Medicine-Hematology

Study Type

Clinical or Medical
Interventional

Study Topics

Cancer (Lymphoma)

IRB Number

23-2508

ClinicalTrials.gov

NCT05976763

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