Zanubrutinib in Mantle Cell Lymphoma

What is the Purpose of this Study?

This study focuses on individuals who have mantle cell lymphoma, which is a type of non-Hodgkin lymphoma. Zanubrutib is a drug approved by the U.S. Food and Drug Administration (FDA) for use in mantle cell lymphoma that has been previously treated. The purpose of the study is to evaluate the use of zanubrutinib in newly diagnosed mantle cell lymphoma that has not yet been treated. The study will compare continuous zanubritinib to treatment with zanubrutinib that is stopped after the initial six 28-day cycles of chemotherapy and restarted at the first time the patient’s disease worsens following the initial cycles of chemotherapy. The addition of zanubritinib to the usual treatment could shrink the patient’s cancer, but it may also cause side effects. Researchers aim to determine whether this approach is better, the same, or worse than the usual approach. The usual approach for patients who are not in a study is treatment with a combination of drugs approved by the U.S. Food and Drug Administration (FDA), including chemotherapy regimens that contain rituximab. Researchers will examine whether the study drugs increase the time to disease progression compared to the usual approach.


Eligibility

  • • Histologically confirmed mantle cell lymphoma with cyclin D1 (BCL1) expression by immunohistochemical stains and/or t(11;14) by cytogenetics or fluorescence in situ hybridization (FISH) as confirmed by the enrolling center
  • Any stage allowed (stage I-IV)
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Where can I participate?

Cedars-Sinai Cancer at SOCC

More about this Clinical Trial

What is the full name of this clinical trial?

A052101: A RANDOMIZED PHASE 3 TRIAL OF CONTINUOUS VS. INTERMITTENT MAINTENANCE THERAPY WITH ZANUBRUTINIB AS UPFRONT TREATMENT IN OLDER PATIENTS WITH MANTLE CELL LYMPHOMA

Study Details
Disease Type/Condition

Other Hematopoietic

Principal Investigator

Darrah, Justin

Co-Investigators

Akil Merchant, Joshua Sasine, Noah Merin, Ronald Paquette

Age Group

Adult

Phase

III

IRB Number

STUDY00003116

ClinicalTrials.gov ID

NCT05976763

Key Eligibility
ClinicalTrials.gov

How do I learn more about this study?
Email
clinicaltrials@cshs.org
Study Detail
Disease Type/Condition

Other Hematopoietic

Principal Investigator

Darrah, Justin

Age Group

Adult

Phase

III

IRB Number

A052101

ClinicalTrials.gov ID

NCT05976763

Key Eligibility
ClinicalTrials.gov

Contact
Email
clinicaltrials@cshs.org