45 Participants Needed

Zanubrutinib + Venetoclax for Chronic Lymphocytic Leukemia

Recruiting at 5 trial locations
JR
KE
HA
HW
MF
DC
Overseen ByDFCI Clinical Trials Hotline
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 study is being done to test the effectiveness of zanubrutinib in combination with venetoclax in participants with previously treated chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).

Will I have to stop taking my current medications?

The trial protocol does not specify if you must stop taking your current medications. However, you cannot take medications that are moderate or strong CYP3A inhibitors or inducers, and you should consult with the trial team about any other medications you are taking.

Is the combination of Zanubrutinib and Venetoclax safe for treating Chronic Lymphocytic Leukemia?

Venetoclax, used in treating Chronic Lymphocytic Leukemia (CLL), has shown an acceptable safety profile in various studies, with common side effects including diarrhea, neutropenia (low white blood cell count), and nausea. Serious side effects like severe neutropenia are manageable with dose adjustments and supportive care.12345

What makes the drug combination of Zanubrutinib and Venetoclax unique for treating chronic lymphocytic leukemia?

The combination of Zanubrutinib and Venetoclax is unique because it combines two oral drugs with different mechanisms: Zanubrutinib targets the Bruton tyrosine kinase (BTK) pathway, while Venetoclax inhibits the B-cell lymphoma 2 (BCL-2) protein, potentially offering a more comprehensive approach to treating chronic lymphocytic leukemia compared to using either drug alone.12367

What data supports the effectiveness of the drug combination Zanubrutinib and Venetoclax for treating Chronic Lymphocytic Leukemia?

Venetoclax has shown to be effective in treating chronic lymphocytic leukemia (CLL), achieving response rates of about 80% in patients with relapsed or refractory CLL. Additionally, BTK inhibitors like Zanubrutinib have been effective in patients with CLL who are resistant to Venetoclax, suggesting potential benefits of combining these drugs.12348

Who Is on the Research Team?

Inhye Ahn, MD - Dana-Farber Cancer ...

Inhye Ahn

Principal Investigator

Dana-Farber Cancer Institute

Are You a Good Fit for This Trial?

Adults with previously treated chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who need therapy and have not used certain inhibitors. They must be in stable health, understand the study, agree to use contraception, and have no history of certain other diseases or recent treatments that could affect safety.

Inclusion Criteria

I agree to use birth control during the study.
I can take care of myself but might not be able to do active work.
Ability to understand and the willingness to sign a written informed consent document
See 7 more

Exclusion Criteria

I have a serious heart condition that is currently affecting me.
I finished IV antibiotics for an infection less than a week ago or have an ongoing infection.
Pregnant women
See 18 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive zanubrutinib and venetoclax for 15 months

15 months

Re-treatment (optional)

Participants may receive an additional 12 months of re-treatment at the time of disease recurrence

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

36 months

What Are the Treatments Tested in This Trial?

Interventions

  • Venetoclax
  • Zanubrutinib
Trial Overview The trial is testing the combination of two drugs, zanubrutinib and venetoclax, for their effectiveness against CLL/SLL in patients who've had previous treatment. It's designed to see how well these drugs work together after initial therapies.
How Is the Trial Designed?
3Treatment groups
Experimental Treatment
Group I: Cohort C: BTKi exposed and with disease progressionExperimental Treatment2 Interventions
Group II: Cohort B: BTKi or BCL2i exposed without disease progressionExperimental Treatment2 Interventions
Group III: Cohort A: BTKi and BCL2i naiveExperimental Treatment2 Interventions

Venetoclax is already approved in United States, European Union for the following indications:

🇺🇸
Approved in United States as Venclexta for:
🇪🇺
Approved in European Union as Venclyxto for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Jennifer R. Brown, MD, PhD

Lead Sponsor

Trials
3
Recruited
140+

Dana-Farber Cancer Institute

Lead Sponsor

Trials
1,128
Recruited
382,000+

BeiGene

Industry Sponsor

Trials
216
Recruited
32,500+

Published Research Related to This Trial

Venetoclax is an oral medication that selectively inhibits the BCL-2 protein, which helps cancer cells survive, thereby restoring the ability of these malignant cells to undergo programmed cell death (apoptosis).
It has been approved in the USA for treating chronic lymphocytic leukaemia (CLL) in patients with a specific genetic marker (17p deletion) who have already undergone at least one prior therapy, and it is being studied for various other blood cancers and conditions.
Venetoclax: First Global Approval.Deeks, ED.[2018]
Venetoclax is a highly effective treatment for relapsed or refractory chronic lymphocytic leukemia (CLL), achieving response rates of about 80% in clinical trials involving 240 patients from 2011 to 2016.
While venetoclax has an acceptable safety profile, common side effects include neutropenia and diarrhea, and there is a risk of tumor lysis syndrome (TLS), which can be managed through careful dose ramp-up and patient education, leading to no reported TLS events in ongoing trials.
Venetoclax: Management and Care for Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia .Brumbaugh Paradis, H., Alter, D., Llerandi, D.[2018]
Venetoclax is an effective oral treatment for relapsed or refractory chronic lymphocytic leukemia (CLL), showing durable responses and a manageable safety profile in clinical trials, including patients with poor prognostic factors.
In combination with rituximab, venetoclax significantly improved progression-free survival and achieved undetectable minimal residual disease compared to bendamustine plus rituximab, with benefits lasting for at least 36 months.
Venetoclax: A Review in Relapsed/Refractory Chronic Lymphocytic Leukemia.Scott, LJ.[2020]

Citations

Venetoclax: First Global Approval. [2018]
Venetoclax: Management and Care for Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia . [2018]
Venetoclax: A Review in Relapsed/Refractory Chronic Lymphocytic Leukemia. [2020]
Venetoclax: A Review in Previously Untreated Chronic Lymphocytic Leukaemia. [2021]
BTK inhibitor therapy is effective in patients with CLL resistant to venetoclax. [2021]
Comprehensive Safety Analysis of Venetoclax Monotherapy for Patients with Relapsed/Refractory Chronic Lymphocytic Leukemia. [2019]
Chronic lymphocytic leukemia at ASH 2017. [2020]
Real-world outcomes and management strategies for venetoclax-treated chronic lymphocytic leukemia patients in the United States. [2020]
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