Phase 2
Completed N=32
A Phase 2 Study of ABT-199 in Subjects With Acute Myelogenous Leukemia (AML)
Source: ClinicalTrials.gov NCT01994837 ↗Enrolled (actual)
32
Serious AEs
84.4%
Results posted
Jan 2018
Primary outcomePrimary: Objective Remission Rate — 18.8 percentage of participants
Summary
This was a Phase 2, open-label, multicenter study evaluating the preliminary efficacy and safety of venetoclax (ABT-199) administered orally in participants with acute myelogenous leukemia (AML).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Objective Remission Rate |
18.8 | — |
| SECONDARY Complete Remission Rate |
6.3 | — |
| SECONDARY Duration of Remission |
— | — |
| SECONDARY Time to Progression |
2.5 | — |
| SECONDARY Progression-free Survival |
2.3 | — |
| SECONDARY Overall Survival |
4.7 | — |
| SECONDARY Percentage of Participants Who Received Subsequent Stem Cell Transplant |
3.1 | — |
| SECONDARY Rate of Minimal Residual Disease (MRD) Negativity |
43.5 | — |
| SECONDARY Complete Remission With Incomplete Marrow Recovery (CRi) Rate |
12.5 | — |
| SECONDARY Complete Remission Rate and Complete Remission With Incomplete Marrow Recovery (CRi) Rate |
18.8 | — |
Eligibility Criteria
Inclusion Criteria
- Histological or cytological confirmation of relapsed or refractory acute myelogenous leukemia (AML) (by World Health Organization [WHO] classification) or untreated AML in participants who are unfit for intensive therapy.
- Participant has an Eastern Cooperative Oncology Group (ECOG) Performance score of 0 to 2.
- Participant must have adequate renal function as demonstrated by a calculated creatinine clearance ≥ 50 mL/min; determined via urine collection for 24-hour creatinine clearance or by the Cockcroft Gault formula using ideal body mass (IBM) instead of mass.
- Participant must have adequate liver function as demonstrated by:
- aspartate aminotransferase (AST) ≤ 3.0 × upper limit of normal (ULN)*
- alanine aminotransferase (ALT) ≤ 3.0 × ULN*
- bilirubin ≤ 1.5 × ULN* *unless considered due to leukemic organ involvement. (Participants with Gilbert's Syndrome may have had a bilirubin > 1.5 × ULN per discussion between the investigator and AbbVie medical monitor)
Exclusion Criteria
- Participant has received acute anti-cancer therapy including chemotherapy, immunotherapy, radiotherapy, hormonal or any investigational therapy within 14 days or 5 half-lives (whichever is shorter) prior to first dose of ABT-199.
- Participant has received a monoclonal antibody for anti-neoplastic intent within 8 weeks prior to the first dose of study drug.
- Participant has received potent Cytochrome P450, family 3, subfamily A (CYP3A) inducers (such as rifampin, carbamazepine, phenytoin and St. John's wort) and warfarin or requires the use of warfarin (due to potential drug-drug interactions that may potentially increase the exposure of warfarin and complications of this effect) within 7 days prior to the first dose of study drug.
- Participant has received CYP3A inhibitors (such as fluconazole, ketoconazole, and clarithromycin) within 5 days prior to the first dose of study drug.
- Participant has a white blood cell count > 25 x 10^9/L.
- Participant has acute promyelocytic leukemia (French-American-British Class M3 AML).
- Participants with known active central nervous system (CNS) disease.
Data sourced from ClinicalTrials.gov (NCT01994837). 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. Informational only — not medical advice.