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A drug, venetoclax, with standard chemotherapy (chemo), to treat B-cell acute lymphoblastic leukemia (ALL) or T-cell ALL (T-ALL) 

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18 and older

Phase 1, Phase 2

5 Locations

NCT03319901

Clinical Trial Goal


To find out:
  • The highest dose of venetoclax that is safe to give with standard chemo
  • If the combination of venetoclax and standard chemo is safe and works well to treat ALL in older adults

You may be able to join this trial if you:


  • Are 18 years old or older
  • Have B-cell or T-cell ALL
  • Do not have leukemia that is Philadelphia chromosome positive (Ph+). Your doctor can tell you this
  • Have not been treated with venetoclax before
  • Agree to have other standard tests done to see if you can be in the clinical trial

Trial Details


Venetoclax is a small molecule inhibitor that blocks BCL2 in certain cells.

You’ll get:
  • Venetoclax – A pill that you take by mouth 1 time each day for 3 weeks of each month. The dose of venetoclax you'll get depends on when you start the trial and how safe it has been
  • Standard chemo – Most of these drugs are given by intravenous (IV) infusion:
    • 6-mercaptopurine
    • Cyclophosphamide
    • Cytarabine
    • Dexamethasone
    • Doxorubicin
    • Etoposide
    • Methotrexate
    • Vincristine

You may continue treatment for as long as the clinical trial doctors think it's best for your health. You'll have bone marrow biopsies to see how well the treatment is working. After you finish treatment, the clinical trial doctors will check your health for up to 2 years.

The Food and Drug Administration (FDA) has approved venetoclax to treat chronic lymphocytic leukemia. Using it to treat ALL in combination with standard chemo is new and unproven.

Contacts


Marlise Luskin, MD, MSCE, 617-632-1909, Marlise_Luskin@DFCI.HARVARD.EDU

Rebecca Leonard, Rebecca_leonard@dfci.harvard.edu

Locations

University of ChicagoRECRUITING

Chicago, Illinois
Wendy Stock, MD, wstock@medicine.bsd.uchicago.edu

Dana Farber Cancer InstituteRECRUITING

Boston, Massachusetts
Contacts:

Massachusetts General HospitalRECRUITING

Boston, Massachusetts
Hanno R Hock, MD, PhD

MD Anderson Cancer CenterRECRUITING

Houston, Texas
Nitin Jain, MD, 713-745-6080, njain@mdanderson.org

Intermountain LDS HospitalRECRUITING

Salt Lake City, Utah
Julie Asch, MD

ClinicalTrials.gov record


NCT03319901. First posted on 10/24/17

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