Chronic Lymphocytic Leukemia Clinical Trial
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
Summary
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 leukemia-cll/" >CLL after B-cell receptor signaling pathway inhibitors (BCR PI) treatment.
Eligibility Criteria
Inclusion Criteria:
Participant must have a diagnosis of chronic lymphocytic leukemia (CLL) that meets 2008 Modified International Workshop on Chronic Lymphocytic Leukemia National Cancer Institute-Working Group (IWCLL NCI-WG) criteria
Participant has relapsed/refractory disease with an indication for treatment
Participant has refractory disease or developed recurrence after therapy with a B-cell receptor pathway inhibitor (BCR PI)
Participant must have an Eastern Cooperative Oncology Group performance score of ≤ 2
Participant must have adequate bone marrow function at Screening
Participant must have adequate coagulation profile, renal, and hepatic function, per laboratory reference range at Screening
Exclusion Criteria:
Participant has undergone an allogeneic stem cell transplant within the past year
Participant has developed Richter's transformation confirmed by biopsy
Participant has active and uncontrolled autoimmune cytopenia
Participant has malabsorption syndrome or other condition that precludes enteral route of administration
Participant is human immunodeficiency virus (HIV) positive or has chronic hepatitis B or hepatitis C virus requiring treatment
Participant has known contraindication or allergy to both xanthine oxidase inhibitors and rasburicase
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There are 13 Locations for this study
La Jolla California, 92093, United States
Los Angeles California, 90095, United States
Stanford California, 94305, United States
Washington District of Columbia, 20007, United States
Atlanta Georgia, 30322, United States
Chicago Illinois, 60611, United States
Boston Massachusetts, 02215, United States
Boston Massachusetts, 02215, United States
New York New York, 10032, United States
New York New York, 10032, United States
Rochester New York, 14642, United States
Columbus Ohio, 43210, United States
Philadelphia Pennsylvania, 19104, United States
Houston Texas, 77030, United States
Salt Lake City Utah, 84112, United States
How clear is this clinincal trial information?

Please confirm you are a US based health care provider:
Yes, I am a health care Provider No, I am not a health care providerSign Up Now.
Take Control of Your Disease Journey.
Sign up now for expert patient guides, personalized treatment options, and cutting-edge insights that can help you push for the best care plan.