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Three drugs, obinutuzumab, venetoclax, and zanubrutinib, to treat chronic lymphocytic leukemia (CLL) or small lymphocytic leukemia (SLL) that has not yet been treated

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18 and older

Phase 2

8 Locations

NCT03824483

Clinical Trial Goal


To find out if the combination of obinutuzumab, venetoclax, and zanubrutinib is safe and works well to treat CLL or SLL that has not yet been treated

You may be able to join this trial if you:


  • Are 18 years old or older
  • Have CLL or SLL and have had little or no treatment
  • Do not have Richter’s transformation
  • Agree to have other standard tests done to see if you can be in the clinical trial

Trial Details


Obinutuzumab is a monoclonal antibody that targets CD20 on certain cells.
Venetoclax is a small molecule inhibitor that blocks BCL2 in certain cells.
Zanubrutinib is a small molecule inhibitor that blocks BTK in certain cells.

You’ll get:
  • Obinutuzumab – Given as an intravenous (IV) infusion 3 – 4 times during the first month, then 1 time each month
  • Venetoclax – A pill that you take by mouth each day starting in the third month
  • Zanubrutinib – A pill that you take by mouth 2 times each day  for 3 times during the first month, then 1 time each month

You may continue treatment for as long as the clinical trial doctors think it’s best for your health. You’ll have biopsies to see how well treatment is working. The clinical trial doctors will check your health for up to 1 year.

The Food and Drug Administration (FDA) has approved obinutuzumab and venetoclax to treat CLL. The FDA has approved zanubrutinib to treat mantle cell lymphoma (MCL). Using them together in this way to treat CLL or SLL that has not yet been treated is new and unproven.

Contacts


Andrew Zelenetz, MD, PhD, 212-639-2656, zeleneta@mskcc.org

Anthony Mato, MD, 212-639-8596

Locations

Northwestern UniversityRECRUITING

Evanston, Illinois
Leo Gordon, MD, 312-695-4546

Massachusetts General Hospital (Data Collection and Specimen Analysis)RECRUITING

Boston, Massachusetts
Jacob D Soumerai, MD, 617-724-4000

Memorial Sloan Kettering at Basking RidgeRECRUITING

Basking Ridge, New Jersey
Andrew Zelenetz, MD, 212-639-2656

Memorial Sloan Kettering MonmouthRECRUITING

Middletown, New Jersey
Andrew Zelenetz, MD, PhD, 212-639-2656

Memorial Sloan Kettering Cancer CenterRECRUITING

New York, New York
Contacts:

  • Andrew Zelenetz, MD, PhD, 212-639-2656
  • Anthony Mato, MD, 212-639-8596

Memorial Sloan Kettering CommackRECRUITING

Commack, New York
Helena Yu, MD, 646-888-4274

Memorial Sloan Kettering NassauRECRUITING

Uniondale, New York
Andrew Zelenetz, MD, PhD, 212-639-2656

Memorial Sloan Kettering WestchesterRECRUITING

Harrison, New York
Andrew Zelenetz, MD, PhD, 212-639-2656

ClinicalTrials.gov record


NCT03824483. First posted on 1/31/19

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