CompletedPhase 1/2

Study of Zanubrutinib in Japanese Participants With B-Cell Malignancies

Japan55 participantsStarted 2020-01-29

Plain-language summary

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.

Who can participate

Age range

20 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Key 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 Waldenström'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 Key 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 thrombocytopen…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Part 1: Number of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs)

Timeframe: Until approximately 6 months after the last dose of zanubrutinib for the last participant who discontinues zanubrutinib or zanubrutinib becomes commercially available for the participant's disease, whichever is earlier

Part 1: Number of Participants Experiencing Treatment-Emergent Serious Adverse Events (SAEs)

Part 1: Number of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation of Treatment

Part 1: Maximum Plasma Concentration (Cmax) of zanubrutinib

Timeframe: Up to 29 days

Part 1: Area under plasma concentration-time curve Concentration (AUC) of zanubrutinib

Timeframe: Up to 29 days

Trial details

NCT IDNCT04172246

SponsorBeiGene

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-05-10

View on ClinicalTrials.gov More Mature B-cell Malignancies trials

Plain-language summary

Who can participate

Age range

20 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Part 1: Number of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs)

Part 1: Number of Participants Experiencing Treatment-Emergent Serious Adverse Events (SAEs)

Part 1: Number of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation of Treatment

Part 1: Maximum Plasma Concentration (Cmax) of zanubrutinib

Timeframe: Up to 29 days

Part 1: Area under plasma concentration-time curve Concentration (AUC) of zanubrutinib

Timeframe: Up to 29 days