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

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