A Phase 2 Open-Label Study of the Efficacy and Safety of ABT-199 (GDC-0199) in Chronic Lymphocytic Leukemia (CLL) Subjects With Relapse or Refractory to B-Cell Receptor Signaling Pathway Inhibitor Therapy



Status:Active, not recruiting
Conditions:Blood Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - 99
Updated:11/4/2018
Start Date:September 10, 2014
End Date:December 8, 2021

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A Phase 2 Open-Label Study of the Efficacy and Safety of ABT-199 (GDC-0199) in Chronic Lymphocytic Leukemia Subjects With Relapse or Refractory to B-Cell Receptor Signaling Pathway Inhibitor Therapy

This is an open-label, non-randomized, multicenter, Phase 2 study evaluating the efficacy and
safety of ABT-199 in approximately 120 subjects with relapsed or refractory CLL after B-cell
receptor signaling pathway inhibitors (BCR PI) treatment.


Inclusion Criteria:

- Subject must have a diagnosis of CLL that meets 2008 Modified International Workshop
on Chronic Lymphocytic Leukemia National Cancer Institute-Working Group (iwCLL NCI-WG)
criteria

- Subject has relapsed/refractory disease with an indication for treatment

- Subject has refractory disease or developed recurrence after therapy with a BCR PI

- Subject must have an Eastern Cooperative Oncology Group performance score of equal to
or less than 2

- Subject must have adequate bone marrow function at Screening

- Subject must have adequate coagulation profile, renal, and hepatic function, per
laboratory reference range at Screening

Exclusion Criteria:

- Subject has undergone an allogeneic stem cell transplant within the past year

- Subject has developed Richter's transformation confirmed by biopsy

- Subject has active and uncontrolled autoimmune cytopenia

- Subject has malabsorption syndrome or other condition that precludes enteral route of
administration

- Subject is human immunodeficiency virus (HIV) positive or has chronic hepatitis B or
hepatitis C virus requiring treatment

- Subject has known contraindication or allergy to both xanthine oxidase inhibitors and
rasburicase.
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Atlanta, Georgia 30322
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303 East Superior Street
Chicago, Illinois 60611
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Houston, Texas 77030
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La Jolla, California 92037
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630 West 168th Street
New York, New York 10027
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Philadelphia, Pennsylvania 19104
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Rochester, Minnesota 55905
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601 Elmwood Avenue
Rochester, New York 14642
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Salt Lake City, Utah 84112
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Salt Lake City, Utah 84112
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Washington, District of Columbia 20007
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