RecruitingPhase 2NCT04941716

Acalabrutinib in Combination With Venetoclax for the Treatment of Refractory or Recurrent Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma, The AVENUE-2 Trial

AVENUE-2: Acalabrutinib in Combination With Venetoclax (AV) for Previously Treated Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)


Sponsor

Fred Hutchinson Cancer Center

Enrollment

20 participants

Start Date

May 31, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

This phase II trial is to evaluate the effects of acalabrutinib in combination with venetoclax in treating patients with chronic lymphocytic leukemia or small lymphocytic lymphoma that does not respond to treatment (refractory) or that has come back (recurrent). Acalabrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Chemotherapy drugs, such as venetoclax, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Given acalabrutinib and venetoclax may kill more cancer cells.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study (AVENUE-2) tests a combination of two targeted drugs — acalabrutinib and venetoclax — for patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) whose disease has returned or not responded to prior treatment. **You may be eligible if...** - You are 18 or older - You have been diagnosed with CLL or SLL that meets standard diagnostic criteria - Your disease is active and requires treatment (e.g., worsening blood counts, enlarged spleen or lymph nodes, or rapidly rising white cell count) - You have previously received treatment that did not work or stopped working **You may NOT be eligible if...** - You have not yet been treated for CLL/SLL - Your disease does not meet criteria for requiring treatment - You have serious other health conditions or active infections - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAcalabrutinib

Given PO

DRUGVenetoclax

Given PO

PROCEDUREBiospecimen Collection

Undergo blood sample collection

PROCEDUREBone Marrow Aspiration

Undergo bone marrow aspiration and biopsy

PROCEDUREBone Marrow Biopsy

Undergo bone marrow aspiration and biopsy

PROCEDUREComputed Tomography

Undergo CT

PROCEDUREMagnetic Resonance Imaging

Undergo MRI


Locations(1)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, United States

View Full Details on ClinicalTrials.gov

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NCT04941716


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