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 |
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.
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.
We found this trial at
17
sites
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