Phase 2
N=127
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
Chronic Lymphocytic Leukemia
Bottom Line
View on ClinicalTrials.gov: NCT02141282 ↗Enrolled (actual)
127
Serious AEs
66.1%
Results posted
Dec 2022
Primary outcome: Primary: Overall Response Rate (ORR) — 64.8; 69.4 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Venetoclax (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- AbbVie
- Primary completion
- Dec 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Response Rate (ORR) |
64.8; 69.4 | — |
| SECONDARY Duration of Response (DOR) |
35.1; 55.4 | — |
| SECONDARY Time to Progression (TTP) |
36.1; 43.4 | — |
| SECONDARY Progression-free Survival (PFS) |
24.7; 43.4 | — |
| SECONDARY Overall Survival (OS) |
69.6; NA | — |
Summary
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.
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
Data sourced from ClinicalTrials.gov (NCT02141282). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.