BGB-16673 + Sonrotoclax for CLL

Overseen By Nitin Jain, MBBS

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: M.D. Anderson Cancer Center

Must not be taking: Warfarin, Strong CYP3A inhibitors

Disqualifiers: HIV, Hepatitis B, Hepatitis C, others

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

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

Compensation: Varies

Number of Visits: Unknown

Duration: 1 year

What You Need to Know Before You Apply

What is the purpose of this trial?

This is an open-label, single-arm, phase II study which will assess the safety and efficacy of BGB16673 in combination with sonrotoclax as a time-limited approach for participants with treatment-naive CLL/SLL.

Who Is on the Research Team?

Nitin Jain, MBBS

Principal Investigator

UT MD Anderson

Are You a Good Fit for This Trial?

Inclusion Criteria

I am fully active or can care for myself with little or no help.

My liver tests are within the allowed range for this study.

Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria

History of allergic reactions attributed to compounds of similar chemical or biological composition to study agents

I do not have an active infection that is not under control.

I do not have serious, uncontrolled heart disease or a recent heart attack.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive BGB-16673 and sonrotoclax on an outpatient basis with hospitalization recommended during dose ramp-up for high tumor burden

1 year

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• BGB-16673
• Sonrotoclax

How Is the Trial Designed?

Group I: Phase 2: Treatment with BGB-16673 + Sonrotoclax Experimental Treatment 2 Interventions

Treatment will be administered on an outpatient basis. However, hospitalization is recommended at each ramp-up dose increase until 24 hours after the dose for participants with high tumor burden at TLS Risk Reassessment.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+