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

BeiGene BGB-11417-301

BeiGene BGB-11417-301
Lymphoma

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

Lymphoma

Eligibility criteria

Inclusion criteria:

  • Treatment-naïve (TN) adults with confirmed diagnosis of CLL which requires treatment
  • Eastern Cooperative Oncology Group (ECOG) score 0, 1, or 2
  • Measurable disease by Computer Tomography/Magnetic Resonance Imaging
  • Adequate liver function as indicated by aspartate aminotransferase (AST) and alanine aminotransferase (ALT) = 2.5 x the institutional upper limits of normal (ULNs) value; serum total bilirubin < 3.0 x ULN
  • Adequate renal function as defined as creatinine clearance = 50 milliliters per minute

Exclusion Criteria:

  • Previous systemic treatment for CLL
  • Known prolymphocytic leukemia or history of, or currently suspected, Richter's transformation transformation
  • Known central nervous system involvement
  • History of confirmed progressive multifocal leukoencephalopathy (PML)
  • Uncontrolled hypertension
  • Note: Other protocol defined criteria may apply
Study details

A 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

Further information

Please click here for more information

Location

Cabrini Health

Cabrini Health :::

Hollywood Private hospital WA

Hollywood Private hospital WA :::

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