← Back to Search

Bcl-2 Inhibitor

Zanubrutinib + Sonrotoclax for Non-Hodgkin's Lymphoma

Duarte, CA

Phase 1

Waitlist Available

Led By Geoffrey Shouse

Research Sponsored by City of Hope Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age: ≥ 18 years on the day of signing the informed consent form

Eastern Cooperative Oncology Group (ECOG) ≤ 2

Must not have

Vaccination or requirement for vaccination with a live vaccine within 35 days prior to the first dose of study drug or at any time during planned study treatment

Major surgery ≤ 4 weeks of the first dose of study drug

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from start of protocol treatment to time of death due to any cause, assessed up to 3 years

Awards & highlights

No Placebo-Only Group

Summary

"This trial is testing a combination of two drugs, zanubrutinib and sonrotoclax, in underrepresented ethnic and racial minorities with B-cell non-Hodgkin lymphoma that

See full description

Who is the study for?

This trial is for underrepresented ethnic and racial minorities with B-cell non-Hodgkin lymphoma that has either relapsed or is refractory. Specific eligibility criteria are not provided, but typically include factors like age, health status, and previous treatments.Check my eligibility

What is being tested?

The trial tests zanubrutinib combined with sonrotoclax in patients. Zanubrutinib targets a protein to stop cancer growth; sonrotoclax blocks another protein to kill cancer cells. The study aims to see if this combination works well in the specified patient group.See study design

What are the potential side effects?

While specific side effects are not listed here, tyrosine kinase inhibitors like zanubrutinib can cause diarrhea, bleeding issues, high blood pressure among others; drugs like sonrotoclax may lead to fatigue, nausea, and risk of infection.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 years old or older.

show original

Select...

I can do most of my daily activities on my own.

show original

Select...

My white blood cell count is healthy.

show original

Select...

My white blood cell count is healthy enough for the trial.

show original

Select...

My kidneys work well enough to clear at least 30 mL/min of creatinine.

show original

Select...

I am a woman who can have children and have a negative pregnancy test.

show original

Select...

My platelet count is at least 75,000/mm^3 without bone marrow issues.

show original

Select...

My platelet count is at least 30,000 if cancer has spread to my bone marrow.

show original

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have not received a live vaccine within 35 days before starting the study drug.

show original

Select...

I have not had major surgery within the last 4 weeks.

show original

Select...

I had a stem cell transplant and am dealing with or treated for GVHD.

show original

Select...

I have been treated with a Bcl2 inhibitor for at least 2 months or my condition worsened on it.

show original

Select...

I need continuous treatment with a strong CYP3A inducer.

show original

Select...

I am currently taking warfarin or similar medications.

show original

Select...

I have not used any restricted substances before starting the study drug.

show original

Select...

My lymphoma/leukemia has spread to my brain or spinal cord.

show original

Select...

I have or am suspected to have a specific blood cancer.

show original

Select...

I do not have any serious heart conditions that are not under control.

show original

Select...

I have severe lung problems.

show original

Select...

I am currently being treated for a serious infection.

show original

Select...

I do not have an active HIV, hepatitis B, or hepatitis C infection.

show original

Select...

I am not pregnant or breastfeeding.

show original

Select...

I have a severe bleeding disorder.

show original

Select...

I cannot swallow pills or have major digestive issues.

show original

Select...

I have an ongoing autoimmune condition affecting my blood.

show original

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from start of protocol treatment to time of death due to any cause, assessed up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from start of protocol treatment to time of death due to any cause, assessed up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and from start of protocol treatment to time of death due to any cause, assessed up to 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Feasibility of completing zanubrutinib lead-in (cycle 1 and cycle 2) and sonrotoclax ramp up (cycle 3)

Feasibility of patient retention through 2 cycles of the combination therapy at a steady dose

Secondary study objectives

CR rate

Incidence of adverse events (AEs)

Overall response rate

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (zanubrutinib, sonrotoclax)Experimental Treatment9 Interventions

Patients receive zanubrutinib PO QD on days 1-28 of each cycle. Starting with cycle 3, patients also receive sonrotoclax PO QD on days 1-28 of each cycle. Cycles repeat every 28 days for up to 28 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo urine and blood sample collection, and CT or MRI throughout the study. Additionally, patients may undergo biopsy at progression and bone marrow aspiration and biopsy throughout the study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Magnetic Resonance Imaging

2020

Completed Phase 3

~1180

Biopsy

2014

Completed Phase 4

~1210