2024-02-13T00:00:00.000+11:00
Ongoing

Beigene BGB-11417-203

Beigene BGB-11417-203
Blood cancer

BGB-11417-301, Phase 3, Open-label, Randomized Study of Sonrotoclax (BGB-11417) plus Zanubrutinib (BGB-3111) Compared with Venetoclax plus Obinutuzumab in Patients with Previously Untreated Chronic Lymphocytic Leukemia.

BGB-11417-301, Phase 3, Open-label, Randomized Study of Sonrotoclax (BGB-11417) plus Zanubrutinib (BGB-3111) Compared with Venetoclax plus Obinutuzumab in Patients with Previously Untreated Chronic Lymphocytic Leukemia.

Trial overview

Topic

Blood cancer, Waldenström’s Macroglobulinemia

Eligibility criteria

Inclusion criteria:

  • Adult Male and Female 18 Years and older
  • Clinical and definitive histologic diagnosis of WM.
  • Meeting = 1 criterion for treatment according to consensus panel criteria from the 2nd  International Workshop on Waldenström's Macroglobulinemia (IWWM).
  • Refractory or relapsed disease to the most recent therapy at study entry unless participants had intolerance to the most recent therapy. Refractory disease is defined as not attaining at least a major response or progressing while on or within 6 months of completing therapy. Relapsed disease is defined as attaining at least a major response to therapy and meeting the criteria for disease progression beyond 6 months after completing therapy.
  • Adequate organ function.

Exclusion Criteria:

  • Central nervous system (CNS) involvement by WM.
  • Transformation to aggressive lymphoma, such as diffuse large B-cell lymphoma.
  • History of other malignancies = 2 years before study entry.
  • Uncontrolled active systemic infection or recent infection requiring parenteral antimicrobial therapy that was completed = 14 days before the first dose of the study drug.
Study details

This study will evaluate the safety and efficacy of the BCL2 inhibitor BGB-11417 in 
participants with relapsed/refractory Waldenström's Macroglobulinemia (R/R WM) in 3 cohorts.

Further information

Please click here for more information

Location
Northshore :::

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