A Drug-Drug Interaction Study of Zanubrutinib with Moderate and Strong CYP3A Inhibitors in Patients with B-Cell Malignancies.
Dr Katharine Lewis
- Chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL)
- Mantle cell lymphoma (MCL),
- Waldenström macroglobulinemia (WM)
- Marginal zone lymphoma (MZL).
This trial is for patients with B-cell lymphoma or chronic lymphocytic leukemia who have previously received standard treatments. This trial looks at the drug interaction between zanubrutinib, a BTK inhibitor, combined with other medications used to treat other health problems. Patients will be allocated to Arm A or Arm B and will take zanubrutinib with other medications by mouth. Patients will continue to take zanubrutinib alone until it stops working or until there are unacceptable side effects.
Include but not limited to:
- Adults ≥ 18 years of age at the time of
- Histologically or cytologically confirmed chronic lymphocytic
leukemia/small lymphocytic lymphoma (CLL/SLL), mantle cell lymphoma (MCL),
Waldenström macroglobulinemia (WM), or marginal zone lymphoma (MZL).
- Patients will be required to have relapsed or refractory disease after at least 1 prior line of systemic therapy
- Baseline Eastern Cooperative Oncology Group performance status score of 0 or 1.
- Patients with MZL will be required to have failed an anti-CD20 monoclonal
antibody-containing chemotherapy regimen
- Requirement of chronic treatment with strong and moderate
CYP3A inhibitors or inducers or with drugs that are not allowed to be used in combination
with the CYP3A inhibitors in this study (ie, fluconazole, diltiazem, voriconazole, or
- A history of stroke or intracranial hemorrhage (within 6 months of treatment
- Known hypersensitivity or contraindication to zanubrutinib, diltiazem, fluconazole,
clarithromycin, or voriconazole
- Prior exposure with zanubrutinib or other Bruton tyrosine
- Any antitumor therapy within 3 weeks of initiating the study drug.
- Patients with moderate or severe hepatic impairment or severe renal impairment will not be
eligible for the study