RecruitingPhase 2NCT04169737

Acalabrutinib and Venetoclax With or Without Early Obinutuzumab for the Treatment of High Risk, Recurrent, or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

A Randomized Phase II Study of Acalabrutinib (ACA) + Venetoclax (VEN) +/- Early Obinutuzumab (OBIN) for Patients With Chronic Lymphocytic Leukemia (CLL)


Sponsor

M.D. Anderson Cancer Center

Enrollment

168 participants

Start Date

Jul 29, 2020

Study Type

INTERVENTIONAL

Conditions

Summary

This phase II trial studies how well acalabrutinib and venetoclax with or without early obinutuzumab work for the treatment of chronic lymphocytic leukemia or small lymphocytic lymphoma that is high risk, has come back (recurrent), or does not respond to treatment (refractory). Acalabrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Venetoclax may stop the growth cancer cells by blocking BCL-2 protein needed for cell growth. Immunotherapy with monoclonal antibodies, such as obinutuzumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving acalabrutinib and venetoclax together with early obinutuzumab may improve clinical outcomes and control the disease.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of two targeted drugs — acalabrutinib and venetoclax, with or without a third drug called obinutuzumab — for treating chronic lymphocytic leukemia (CLL), a type of blood cancer. It includes both newly diagnosed patients and those whose cancer has come back or stopped responding to treatment. **You may be eligible if...** - You are 18 or older - You have been diagnosed with CLL or small lymphocytic lymphoma (SLL) and need treatment - If newly diagnosed: you have high-risk features or are 65 or older - If previously treated: your cancer relapsed or did not respond to at least one prior therapy - Your kidneys and liver are functioning adequately **You may NOT be eligible if...** - You have certain genetic mutations that make these drugs less effective (e.g., certain BCL2 mutations) - You have active infections like hepatitis B or C, or HIV - You have uncontrolled heart rhythm problems - You need certain blood thinners that cannot be safely paused 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

BIOLOGICALObinutuzumab

Given IV

DRUGVenetoclax

Given PO


Locations(1)

M D Anderson Cancer Center

Houston, Texas, United States

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NCT04169737


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