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A Study of ACP-196 Versus Ibrutinib in Previously Treated Subjects with High Risk Chronic Lymphocytic Leukemia

Study Summary

  • Study patients will be randomized (like the flip of a coin) into one of two groups
      • Arm A: You will take ACP-196 two times a day. The treatment is a 100 mg capsule that you will take orally.
      • Arm B: You will take Ibrutinib once a day. The treatment is to take 3 capsules of Ibrutinib 420 mg orally.
  • For either treatment arm, you will continue the treatment as long as possible. You will only stop taking your treatment if your disease progresses, you become sick from the treatment or you or your physician feel that is it in your best interest to stop the study
  • About 500 people will take part in this research study
  • Study drug will be provided

Protocol

  • ACE-CL-006

Phase

  • III

Investigator

  • Dr. Kenneth Blankstein

Disease

  • Chronic Lymphocytic Leukemia (CLL)

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Inclusion

  • 18 years of age or older
  • You will need to have one of the following mutations (if you are not sure, please ask your physician):
    • 17p deletion
    • 11q deletion
  • Active disease (we can help you determine if you are considered active or not)
  • Measurable nodal disease by computed tomography (≥1 lymph node lesion with ≥1.5 cm longest diameter)
  • Had 1 or more prior therapies for CLL

Exclusion

  • Central nervous system lymphoma or leukemia. Prolymphocytic leukemia or history of or currently suspected Richter’s syndrome
  • Uncontrolled autoimmune hemolytic anemia or idiopathic thrombocytopenic purpura
  • Prior exposure to ibrutinib or to a B-cell receptor inhibitor
  • Any chemotherapy or radiation within 30 days of study start
  • Corticosteroids use over 20 mg within 7 days of study start
  • Prior radio- or toxin-conjugated antibody therapy
  • Prior allogeneic stem cell or autologous transplant
  • Major surgery within 4 weeks before study start
  • Prior malignancy (there are a few exceptions)
  • Active and clinically significant cardiovascular
  • Active hepatitis B or C. History of HIV
  • Stroke or intracranial hemorrhage within 6 months of study start
  • History of bleeding diathesis
  • Requires or receiving anticoagulation with warfarin or an equivalent within 28 days of study start
  • Requires treatment with a strong cytochrome P450 3A4 inhibitor/inducer
  • Requires treatment with long-acting proton pump inhibitors

NOTE: The inclusion and exclusion criteria for this study may be confusing, so if you are having a hard time deciding if you may be eligible, feel free to contact us!


If you have any questions regarding this study or think that
you or your loved one may be eligible, please feel free to contact:

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Serena Schmitz • 908-237-2330 ex 2 • sschmitz@hhsnj.org