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Bruton's Tyrosine Kinase (BTK) Inhibitor

Acalabrutinib + Venetoclax for Chronic Lymphocytic Leukemia

Phase 2

Recruiting

Led By Mazyar Shadman

Research Sponsored by Fred Hutchinson Cancer Research Center

Eligibility Criteria Checklist

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

Must have

Night sweats for > 1 month without evidence of infection

Relapsed or refractory to at least 1 prior systemic therapy for CLL/SLL. A line of therapy is defined as completing at least 2 cycles of treatment of standard regimen according to current National Comprehensive Cancer Network (NCCN) guidelines, or of an investigational regimen on a clinical trial

Must not have

History of confirmed progressive multifocal leukoencephalopathy (PML)

Prior disease progression while on venetoclax

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 10 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new cancer treatment combining acalabrutinib with venetoclax to see if it's more effective than either drug alone in treating patients with leukemia or lymphoma that has resisted or returned after treatment.

Who is the study for?

Adults diagnosed with chronic lymphocytic leukemia or small lymphocytic lymphoma that's resistant to treatment or has returned. They must have had night sweats for over a month, relapsed after at least one therapy, and meet specific health criteria like certain blood cell counts and organ function tests. Pregnant women, those with other active cancers, significant heart issues, absorption problems, recent major surgeries, or infections like hepatitis B/C or HIV cannot join.

What is being tested?

The trial is testing the combination of two drugs: Acalabrutinib and Venetoclax in patients whose chronic lymphocytic leukemia or small lymphocytic lymphoma hasn't responded to previous treatments. The goal is to see if this drug combo can better halt cancer growth by blocking enzymes needed for cell growth and killing cancer cells.

What are the potential side effects?

Potential side effects include increased risk of infection due to low white blood cell count; nausea; fatigue; diarrhea; muscle and joint pain; headache; fever. Some may experience liver enzyme changes indicating liver impact. Rare but serious side effects could involve bleeding problems or severe allergic reactions.

Eligibility Criteria

Inclusion Criteria

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

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I have had night sweats for over a month without being sick.

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My CLL/SLL has not improved or has returned after at least one treatment.

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My spleen is very large, growing, or causing symptoms.

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I am able to get out of my bed or chair and move around.

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I have had a fever over 100.5°F or 38°C for 2 weeks without signs of infection.

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I have been diagnosed with CLL or SLL according to standard criteria.

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My condition requires treatment according to the latest guidelines.

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My blood tests show worsening anemia or low platelet counts.

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My lymph nodes are very large or getting worse and causing symptoms.

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I have lost more than 10% of my weight without trying in the last 6 months.

Exclusion Criteria

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

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I have been diagnosed with progressive multifocal leukoencephalopathy.

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My condition worsened while I was on venetoclax.

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I have HIV or a serious infection.

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I am not on strong drugs that affect liver enzymes.

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I have not had major surgery in the last 7 days or have fully recovered if I did.

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I do not have uncontrolled AIHA or ITP.

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My condition worsened while I was on a BTK inhibitor.

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I do not have a bleeding disorder nor am I on strong blood thinners like warfarin.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 10 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 10 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 10 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

Rate of undetectable measurable residual disease (uMRD)

Secondary study objectives

Complete response (CR)

Heart rate

Overall survival (OS)

+3 more

Side effects data

From 2020 Phase 2 trial • 177 Patients • NCT04346199

Headache

Septic shock

Ischaemic stroke

Chronic obstructive pulmonary disease

100%

80%

60%

40%

20%

Study treatment Arm

BSC Alone

Acalabrutinib + BSC

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 (acalabrutinib, venetoclax)Experimental Treatment7 Interventions

Patients receive acalabrutinib PO BID and venetoclax PO QD on days 1-28. Patients receive acalabrutinib alone for the first three 28 day cycles. Venetoclax is added beginning with Cycle 4. Treatment repeats every 28 days for up to 26 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo blood sample collection, bone marrow aspiration and biopsy, and CT or MRI throughout the trial.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Bone Marrow Aspiration

2011

Completed Phase 2

~1740

Biospecimen Collection

2004

Completed Phase 3

~2020