Study of BTK Inhibitor BGB-3111 in Chinese Subjects With Relapsed/Refractory Waldenström's Macrog… (NCT03332173) | Clinical Trial Compass
CompletedPhase 2
Study of BTK Inhibitor BGB-3111 in Chinese Subjects With Relapsed/Refractory Waldenström's Macroglobulinemia (WM)
China44 participantsStarted 2017-08-31
Plain-language summary
This was a single-arm, multicenter Phase 2 study in Chinese participants with relapsed or refractory Waldenström's macroglobulinemia who exhibited one or more of the criteria for requiring treatment based on consensus guidelines from the Seventh International Workshop on Waldenström's Macroglobulinemia (IWWM). The study comprised an initial screening phase (up to 28 days), a single-arm treatment phase, and a follow-up phase.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Clinical and definitive histologic diagnosis of WM, meeting at least one criterion for treatment according to consensus panel criteria from the Seventh IWWM.
✓. WM pathology confirmation by central lab prior to study enrollment. Previous pathology report, concurrently with newly generated central lab report to be reviewed to support WM diagnosis.
✓. Men and women ≥ 18 years of age.
✓. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
✓. Previously treated with a minimum of 1 prior line of standard chemotherapy-containing regimen (with completion of ≥ 2 continuous treatment cycles).
✓. Documented failure to achieve at least minor response or documented disease progression after response to the most recent treatment regimen.
✓. Neutrophils ≥ 0.75 x 10\^9/L independent of growth factor support within 7 days of first dose.
✓. Platelets ≥ 50 x 10\^9/L, independent of growth factor support or transfusion within 7 days of first dose.
Exclusion criteria
✕. Central nervous system (CNS) involvement by WM.
✕. Prior exposure to a BTK inhibitor.
✕. Evidence of disease transformation.
✕. Prior corticosteroids given in excess of prednisone 10 mg/day or its equivalent with antineoplastic intent within 7 days, prior chemotherapy, targeted therapy, or radiation therapy within 3 weeks, antineoplastic therapy with Chinese herbal medicine or antibody based therapies within 4 weeks of the start of study drug.
What they're measuring
1
Major Response Rate (MRR) as Assessed by the Independent Review Committee
Timeframe: Up to approximately 1 year and 9 months
✕. Major surgery within 4 weeks of randomization.
✕. Toxicity of ≥ Grade 1 from prior anti-cancer therapy (except for absolute neutrophil count \[ANC\], platelets, and hemoglobin. For ANC, platelets, and hemoglobin, please follow inclusion criteria #7 \[neutrophils\], #8 \[platelets\], and #9 \[hemoglobin\]).
✕. History of other active malignancies within 2 years of study entry, with exception of (1) adequately treated in-situ carcinoma of cervix; (2) localized basal cell or squamous cell carcinoma of skin; (3) previous malignancy confined and treated locally (surgery or other modality) with curative intent.
✕. Currently active clinically significant cardiovascular disease such as uncontrolled arrhythmia, uncontrolled hypertension, congestive heart failure, any Class 3 or 4 cardiac disease as defined by the New York Heart Association (NYHA) Functional Classification, or history of myocardial infarction within 6 months of screening.