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A Phase 2 Study of ABT-199 in Subjects With Acute Myelogenous Leukemia (AML)
Not Recruiting
Trial ID: NCT01994837
Purpose
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).
Official Title
A Phase 2 Study of ABT-199 in Subjects With Acute Myelogenous Leukemia (AML)
Eligibility
Inclusion Criteria:
1. 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.
2. Participant has an Eastern Cooperative Oncology Group (ECOG) Performance score of 0 to
2.
3. 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.
4. 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:
1. 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.
2. Participant has received a monoclonal antibody for anti-neoplastic intent within 8
weeks prior to the first dose of study drug.
3. 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.
4. Participant has received CYP3A inhibitors (such as fluconazole, ketoconazole, and
clarithromycin) within 5 days prior to the first dose of study drug.
5. Participant has a white blood cell count > 25 x 10^9/L.
6. Participant has acute promyelocytic leukemia (French-American-British Class M3 AML).
7. Participants with known active central nervous system (CNS) disease.
Intervention(s):
drug: ABT-199
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
CCTO
650-498-7061