Sonrotoclax Combinations for Chronic Lymphocytic Leukemia

Recruiting at 153 trial locations

Overseen By Study Director

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: BeiGene

Disqualifiers: Prolymphocytic leukemia, Richter's transformation, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: Unknown

Duration: Up to approximately 26 months

630 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this study is to compare how well sonrotoclax plus obinutuzumab works versus venetoclax plus rituximab in treating adults with relapsed and/or refractory (R/R) chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). The study will also compare how well sonrotoclax plus rituximab works versus venetoclax plus rituxumab in treating adults with R/R CLL/SLL. The safety of these treatments will also be assessed.

Research Team

Study Director

Principal Investigator

BeiGene

Eligibility Criteria

This trial is for adults with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) who have had at least one prior treatment. Participants should meet specific CLL criteria, have completed at least two cycles of previous therapy, and be in remission for three years if previously treated with BCL2 inhibitors.

Inclusion Criteria

I have had at least 2 cycles of treatment for my CLL/SLL.

I am able to care for myself and perform daily activities.

My organs are working well.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either sonrotoclax plus obinutuzumab, sonrotoclax plus rituximab, or venetoclax plus rituximab

Up to approximately 26 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to approximately 84 months

Treatment Details

Interventions

• Obinutuzumab
• Rituximab
• Sonrotoclax
• Venetoclax

Trial Overview The study compares the effectiveness of sonrotoclax combined with obinutuzumab or rituximab against venetoclax plus rituximab in treating CLL/SLL. It aims to determine which combination leads to longer progression-free survival while also evaluating the safety of these treatments.

Participant Groups

Group I: Arm C: Sonrotoclax plus Obinutuzumab (MRD) Experimental Treatment 2 Interventions

Sonrotoclax and obinutuzumab will be administered in combination with treatment guided by evaluation of minimal residual disease (MRD).

Group II: Arm B: Sonrotoclax plus Rituximab Experimental Treatment 2 Interventions

Sonrotoclax and rituximab will be administered in combination.

Group III: Arm A: Sonrotoclax plus Obinutuzumab Experimental Treatment 2 Interventions

Sonrotoclax and obinutuzumab will be administered in combination.

Group IV: Arm D: Venetoclax plus Rituximab Active Control 2 Interventions

Venetoclax and rituximab will be administered in combination.

Who Is Running the Clinical Trial?

BeiGene

Lead Sponsor

Trials

216

Recruited

32,500+

German CLL Study Group

Collaborator

Trials

49

Recruited

21,400+