Phase 2
N=86
Study to Evaluate Efficacy and Safety of BGB-3111 in Participants With Relapsed or Refractory Mantle Cell Lymphoma (MCL)
Refractory Mantle Cell Lymphoma · Relapsed Mantle Cell Lymphoma
Bottom Line
View on ClinicalTrials.gov: NCT03206970 ↗Enrolled (actual)
86
Serious AEs
29.1%
Results posted
May 2020
Primary outcome: Primary: Overall Response Rate (ORR) As Assessed By Independent Review Committee — 72 Participants — p=<.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Zanubrutinib (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- BeiGene
- Primary completion
- Feb 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Response Rate (ORR) As Assessed By Independent Review Committee |
72 | <.0001 sig |
| SECONDARY Progression-free Survival |
33.0 | — |
| SECONDARY Time To Response |
2.72 | — |
| SECONDARY Duration Of Response |
NA | — |
| SECONDARY ORR As Assessed By The Investigator |
72 | <0.0001 sig |
| SECONDARY Number Of Participants Experiencing Treatment -Emergent Adverse Events (AEs) |
83 | — |
| SECONDARY Number Of Participants Experiencing AEs Leading To Treatment Discontinuation |
8 | — |
Summary
The primary objective of this study was to evaluate the efficacy of zanubrutinib in participants with centrally confirmed relapsed or refractory MCL.
Eligibility Criteria
Key Inclusion Criteria
- Diagnostic report had to include evidence for morphological and cyclin D1 or t (11; 14).
- Eastern Cooperative Oncology Group performance status of 0-2.
- Measurable disease by computed tomography/magnetic resonance imaging.
- Received prior regimens for MCL.
- Documented failure to achieve any response, (stable disease or progressive disease during treatment) or documented progressive disease after response to the most recent treatment regimen.
- Aspartate aminotransferase and alanine aminotransferase ≤ 2.5 x upper limit of normal (ULN).
- Total bilirubin ≤ 2 x ULN (unless documented Gilbert's syndrome).
- Life expectancy of > 4 months.
Key Exclusion Criteria
- Current or history of central nervous system lymphoma.
- Prior exposure to a BTK inhibitor before enrollment.
- Prior corticosteroids with anti-neoplastic intent within 7 days.
- Major surgery within 4 weeks of screening.
- Toxicity must have recovered from prior chemotherapy.
- History of other active malignancies within 2 years of study entry.
- Currently clinically significant active cardiovascular disease.
- QT interval corrected with Fridericia's formula > 450 microseconds or other significant electrocardiogram abnormalities.
- Uncontrolled systemic infection or infection requiring parenteral anti-microbial therapy.
- Known human immunodeficiency virus infection, or active hepatitis B or hepatitis C infection (detected positive by polymerase chain reaction).
Note: Other protocol-defined Inclusion/Exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT03206970). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.