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
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
AbbVie
With
Roche-Genentech
Age
18–99
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible 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 be 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
Clareo Health | 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
