155 Participants NeededMy employer runs this trial

Venetoclax + Zanubrutinib for Chronic Lymphocytic Leukemia

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Overseen ByThe Ohio State University Comprehensive Cancer Center
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Kerry Rogers
Must be taking: Venetoclax, Zanubrutinib
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effectiveness of combining the drugs venetoclax and zanubrutinib to treat chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). Venetoclax may block a protein that helps cancer cells survive, while zanubrutinib might inhibit cancer cell growth. The trial aims to determine if these drugs together can safely reduce cancer cells in individuals with CLL or SLL who have not received treatment before or have not been treated in over two years. This trial may suit those diagnosed with CLL or SLL who haven't had recent treatment or completed initial treatment at least two years ago. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that the combination of venetoclax and zanubrutinib is generally well-tolerated by patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). One study found that the most common serious side effects included low white blood cell counts (24%), high blood pressure (9%), and diarrhea (6%). While monitoring these side effects is necessary, the treatment is considered safe overall.

Zanubrutinib, a newer cancer drug, has demonstrated effectiveness and safety in patients with CLL/SLL. Another report highlights that this drug combination is very safe, with no unexpected harmful effects. Although some patients may experience side effects, research supports that these treatments are manageable for many.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about Venetoclax and Zanubrutinib for Chronic Lymphocytic Leukemia (CLL) because these drugs offer a novel approach compared to standard treatments like chemoimmunotherapy or other BTK inhibitors. Venetoclax works by targeting and inhibiting a protein called BCL-2, which helps cancer cells survive, leading to their death. Zanubrutinib, a newer BTK inhibitor, may offer better selectivity and fewer side effects than older drugs like Ibrutinib. Together, these drugs aim to improve patient outcomes by effectively targeting cancer cells with potentially fewer side effects.

What evidence suggests that venetoclax and zanubrutinib might be effective treatments for chronic lymphocytic leukemia?

Studies have shown that combining venetoclax and zanubrutinib effectively treats chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). In this trial, participants in both Cohort I and Cohort II will receive this combination. Research indicates that this treatment achieves an 87% progression-free survival (PFS) rate at 36 months, meaning most patients did not experience cancer progression over three years. Additionally, earlier studies found that 95% of patients responded well to the treatment. This combination blocks proteins that help cancer cells grow, potentially stopping the cancer from spreading. These findings suggest that this combination has strong potential to effectively manage CLL and SLL.678910

Who Is on the Research Team?

KA

Kerry A Rogers, MD

Principal Investigator

Ohio State University Comprehensive Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have either never been treated before or finished their last treatment at least two years ago.

Inclusion Criteria

I have had only one previous treatment, not counting rituximab or anti-CD20 for ITP or AIHA.
My platelet count is above 30,000 without needing growth factor support.
Creatinine clearance (CrCl) ≥ 50 by modified Cockcroft-Gault equation
See 14 more

Exclusion Criteria

I currently have active Richter's transformation.
I have taken zanubrutinib before.
I have a known tendency to bleed easily.
See 21 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients receive SOC zanubrutinib and venetoclax. Cycles repeat every 28 days for up to 15 cycles for Cohort I and up to 27 cycles for Cohort II.

15-27 months
Monthly visits for each cycle

Follow-up

Participants are monitored for safety and effectiveness after treatment completion. Follow-up occurs at 28 days, every 12 weeks up to progression, then every 6 months for up to 5 years.

Up to 5 years
Regular follow-up visits every 3 to 6 months

What Are the Treatments Tested in This Trial?

Interventions

  • Venetoclax
  • Zanubrutinib

Trial Overview

The study is testing a combination of two drugs, venetoclax and zanubrutinib, to see if they work well together in treating CLL or SLL. Patients will also undergo scans and lab tests as part of the study.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Cohort II (SOC zanubrutinib, venetoclax)Experimental Treatment7 Interventions
Group II: Cohort I (SOC zanubrutinib, venetoclax)Experimental Treatment7 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Kerry Rogers

Lead Sponsor

Trials
3
Recruited
120+

AbbVie

Industry Sponsor

Trials
1,079
Recruited
535,000+
Founded
2013
Headquarters
North Chicago, USA
Known For
Immunology treatments
Top Products
Humira (adalimumab), Skyrizi (risankizumab), Rinvoq (upadacitinib)

Citations

Zanubrutinib and Venetoclax for Patients With Treatment- ...

Zanubrutinib + venetoclax demonstrated impressive efficacy and a favorable safety profile in patients with TN CLL/SLL, regardless of the ...

2.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40448577/

Zanubrutinib and Venetoclax for Patients With Treatment- ...

Conclusion: Zanubrutinib + venetoclax demonstrated impressive efficacy and a favorable safety profile in patients with TN CLL/SLL, regardless of ...

Zanubrutinib-Venetoclax Pairing Yields Encouraging ...

At ASCO 2025, zanubrutinib and venetoclax demonstrated strong and sustained responses in treatment naive CLL and SLL with or without del 17p ...

Zanubrutinib/Venetoclax Continues to Impress in ...

Zanubrutinib and venetoclax combination shows an 87% 36-month PFS rate in CLL/SLL patients, regardless of del(17p)/TP53 or IGHV status.

Comparative Efficacy of Zanubrutinib (ZANU) versus Fixed- ...

The 36-month PFS rate for ZANU was 85.6% before matching and 88.5% after matching, compared with 76.5% for AV. Sensitivity analyses confirmed consistent ...

Sequential and combination treatments with novel agents in ...

After 12 months of combined venetoclax and ibrutinib the CR/CRi rate was 96% and 69% of the patients had no detectable MRD in the bone marrow.

Zanubrutinib + Venetoclax for Treatment-naive Chronic ...

The most common Grade ≥3 adverse events (AEs) were neutropenia/neutrophil count decreased (24%), hypertension (9%), and diarrhea (6%).

Preliminary Safety and Efficacy Data from Patients (Pts) ...

Zanubrutinib is a next-generation BTK inhibitor that has shown excellent activity and favorable toxicity in pts with CLL/SLL

COMPARATIVE EFFICACY OF ZANUBRUTINIB VERSUS ...

The 36-month PFS rate for ZANU was 85.6% before matching and 88.5% after matching, compared with 76.5% for AV (Table). Sensitivity analyses ...

Zanubrutinib in Patients with CLL and Intolerance to Prior BTKIs

The data showed the recurrence of the adverse effects with ibrutinib was about 30%. Venetoclax/HMA Combo Demonstrates Real-World Efficacy in ...