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RecruitingLast updated: 6 February 2024

This study is comparing the efficacy of two different combinations of targeted therapies in people with chronic lymphocytic leukaemiaA 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

Clinical summary

Summary

Eligible participants will be randomly allocated to one of two treatment arms. Both arms will receive a combination of targeted therapy. Treatment cycles are 28 days.

In the Experimental Arm, participants will receive Sonrotoclax plus Zanubrutinib. Participants will receive, from the start of Cycle 1, a standard dose of oral zanubrutinib once or twice daily, and in combination with oral sonrotoclax starting from Cycle 4 onwards at increasing doses until the target dose is reached and continuing until end of Cycle 15.

In the Active Comparator Arm, participants will receive Venetoclax plus Obinutuzumab. Participants will receive obinutuzumab 100mg intravenously on Day 1 Cycle 1, followed by 900mg on Day 2 Cycle 1 (or alternatively receive 1000mg intravenously on Day 1) followed by 1000mg on Days 8 and 15 of Cycle 1, and thereafter on Day 1 of Cycles 2 through 6 in combination with oral venetoclax at increasing doses until target dose is reached from Day 22 Cycle 1 until end of Cycle 12. 

Conditions

This trial is treating patients with chronic lymphocytic leukaemia who have not had prior treatment

Cancer

Blood Cancers Haematological

Age

People18+

Phase

III

More information

Trial Identifiers

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Trial sponsor

BeiGene

Scientific Title

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

Eligibility

Inclusion

  • 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

  • Previous systemic treatment for CLL
  • Known prolymphocytic leukemia or history of, or currently suspected, Richter's transformation
  • Known central nervous system involvement
  • History of confirmed progressive multifocal leukoencephalopathy (PML)
  • Uncontrolled hypertension

Note: Other protocol defined criteria may apply

Inclusion

  • You have been diagnosed with cancer, but have not received any treatment.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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Recruiting hospitals

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