NO_LONGER_AVAILABLENot Applicable

A Single-Arm, Expanded Access Study of Zanubrutinib in Participants With B-cell Malignancies

United States

Plain-language summary

This is a multicenter expanded access study of zanubrutinib monotherapy for participants with B-cell malignancies who are ineligible to enroll into any available zanubrutinib clinical trials

Who can participate

Age range18 Years

SexALL

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

Inclusion criteria

✓. Histologically confirmed diagnosis of WM with R/R disease or treatment-naive and considered by their treating physician to be unsuitable for standard chemoimmunotherapy regimens
✓. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
✓. Absolute neutrophil count (ANC) ≥ 0.75 x 109/L, independent of growth factor support; and Platelet count ≥ 50 x 109/L, independent of growth factor support or transfusion within 7 days of study entry
✓. Creatinine clearance of ≥ 30 mL/min
✓. Aspartate aminotransferase (AST)/serum glutamic-oxaloacetic transaminase (SGOT) and alanine aminotransferase (ALT)/serum glutamic pyruvic transaminase (SGPT) ≤ 3 x upper limit of normal (ULN)
✓. Total bilirubin level ≤ 2 x ULN (unless documented Gilbert's syndrome)

Exclusion criteria

✕. Prior exposure to a Bruton tyrosine kinase (BTK) inhibitor
✕. Evidence of disease transformation at the time of study entry
✕. Ongoing requirement for systemic corticosteroid other than systemic adrenal replacement therapy
✕. Chemotherapy given with antineoplastic intent, targeted therapy, radiation therapy or antibody-based therapy within 4 weeks of the start of study drug
✕. Ongoing toxicity of ≥ Grade 2 from prior anticancer therapy
✕. Prior or concurrent active malignancy within the past 2 years
✕. Clinically significant cardiovascular disease
✕. Unable to swallow capsules or disease significantly affecting gastrointestinal function

Trial details

NCT IDNCT04052854

SponsorBeiGene

Sponsor typeINDUSTRY

Study typeEXPANDED_ACCESS

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