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

Completed · Phase 2

Conditions studied: Chronic Lymphocytic Leukemia

In brief

This was an open-label, non-randomized, multicenter, Phase 2 study evaluating the efficacy and safety of ABT-199 in 127 participants with relapsed or refractory chronic lymphocytic leukemia (CLL) after B-cell receptor signaling pathway inhibitors (BCR PI) treatment.

Key facts

Study ID

NCT02141282

Run by

AbbVie

People needed

127

Starts

2014-09-10

Expected to finish

2021-12-22

Last updated by the study team

2022-12-19

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Moores Cancer Center at UC San Diego /ID# 128535 — La Jolla, California, United States
• University of California, Los Angeles /ID# 127262 — Los Angeles, California, United States
• Stanford University School of Med /ID# 126495 — Stanford, California, United States
• Georgetown University Hospital /ID# 127261 — Washington D.C., District of Columbia, United States
• Emory Midtown Infectious Disease Clinic /ID# 131249 — Atlanta, Georgia, United States
• Northwestern University Feinberg School of Medicine /ID# 126497 — Chicago, Illinois, United States
• Beth Israel Deaconess Medical Center /ID# 134509 — Boston, Massachusetts, United States
• Dana-Farber Cancer Institute /ID# 126496 — Boston, Massachusetts, United States
• Columbia Univ Medical Center /ID# 128536 — New York, New York, United States
• New York Presbyterian Hospital Weill Cornell Medical Center /ID# 129648 — New York, New York, United States
• Univ Rochester Med Ctr /ID# 130011 — Rochester, New York, United States
• The Ohio State University /ID# 127263 — Columbus, Ohio, United States
• University of Pennsylvania /ID# 126860 — Philadelphia, Pennsylvania, United States
• University of Texas MD Anderson Cancer Center /ID# 126498 — Houston, Texas, United States
• University of Utah /ID# 130813 — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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