Study of Zanubrutinib in Japanese Participants With B-Cell Malignancies

  • End date
    Jul 6, 2022
  • participants needed
  • sponsor
Updated on 1 March 2021
Eric Hedrick, MD
Primary Contact
Kurume University Hospital (0.6 mi away) Contact
+14 other location


This is a Phase 1/2 study of zanubrutinib in Japanese participants with mature B-cell malignancies.

This study intends to assess the use of zanubrutinib as an investigational agent to develop new treatment options for Japanese participants with B-cell malignancies. No formal hypothesis testing will be performed given the small sample size.

Condition Mature B-cell Malignancies, Mature B-cell Malignancies, Mature B-cell Malignancies
Treatment Zanubrutinib
Clinical Study IdentifierNCT04172246
Last Modified on1 March 2021


Yes No Not Sure

Inclusion Criteria

Participants with Confirmed diagnosis of mature B-cell neoplasms including chronic lymphocytic leukemia/ small lymphocytic lymphoma, mantle cell lymphoma, follicular lymphoma, marginal zone lymphoma and Waldenstrm's macroglobulinemia
Relapsed/refractory disease defined as disease that relapsed after, or been refractory to, at least 1 prior therapy
Meeting at least one of criteria for requiring treatment
Measurable disease by computed tomography (CT)/ magnetic resonance imaging (MRI) for mantle cell lymphoma (MCL), marginal zone lymphoma (MZL) and follicular lymphoma (FL) participants and by serum immunoglobulin (Ig) M level > 0.5 g/dL for WM participants
Eastern Cooperative Oncology Group performance status of 0, 1, or 2
Life expectancy of > 4 months

Exclusion Criteria

Known central nervous system involvement by lymphoma/leukemia
Known plasma cell neoplasm, prolymphocytic leukemia, history of or currently suspected Richter's syndrome
Prior allogeneic stem cell transplant
Systemic chemotherapy or radiation therapy within 2 weeks prior to first dose of zanubrutinib
Active fungal, bacterial, and/or viral infection requiring systemic therapy
Prior therapy with B-cell receptor inhibitor (eg, Bruton tyrosine kinase, phosphoinositide 3 kinase delta, and/or spleen tyrosine kinase inhibitor) or B-cell lymphoma 2 inhibitor (eg, venetoclax/ABT-199)
Pregnant, lactating, or nursing women
Autoimmune anemia and/or thrombocytopenia that is poorly responsive to corticosteroids or other standard therapy
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
Clear my responses

How to participate?

Step 1 Connect with a site
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact


Phone Email

Preferred Language
Other Language
Please verify that you are not a bot.

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider


Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 



Reply by • Private

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note