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.
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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)
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 Adverse Events (AEs) Leading to Discontinuation of Treatment
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: 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
Part 2: Overall response rate as assessed by Independent Review Committee (IRC)
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 occurs first