Acute Myeloid Leukemia Clinical Trial
Study of ABT-199 (GDC-0199) in Combination With Azacitidine or Decitabine (Chemo Combo) in Subjects With Acute Myelogenous Leukemia (AML)
This is a Phase 1b, open-label, non-randomized, multicenter study to evaluate the safety and pharmacokinetics of orally administered venetoclax (ABT-199) combined with decitabine or azacitidine and the preliminary efficacy of these combinations. In addition, there is a drug-drug interaction (DDI) sub-study only at a single site, to assess the pharmacokinetics and safety of venetoclax (ABT-199) in combination with posaconazole.
Subjects must have confirmation of Acute Myeloid Leukemia (AML) by WHO criteria and be ineligible for treatment with a standard cytarabine and anthracycline induction regimen due to co-morbidity or other factors.
Subject must have received no prior treatment for AML with the exception of hydroxyurea
Subjects must have Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2 for subjects greater than or equal to 75 years of age, or 0 to 3 for subjects greater than or equal to 60 to 74 years of age
Subject must have adequate kidney and liver function as described in the protocol
Subject has received treatment with the following hypomethylating agent and/or chemo therapeutic agent for for an antecedent hematologic disorder (AHD) (Subjects may have been treated with other agents for AHD i.e., Myelodysplastic syndrome [MDS])
Subject has history of Myeloproliferative Neoplasm (MPN).
Subject has favorable risk cytogenetics as categorized by the National Comprehensive Cancer Network Guidelines Version 2, 2014 for AML.
Subject has t(8;21), inv(16), t(16;16) or t(15;17) karyotype abnormalities.
Subject has acute promyelocytic leukemia.
Subject has known active central nervous system involvement with AML.
Subject has received a strong and/or moderate CYP3A inducer within 7 days prior to the initiation of study treatment.
Subject has a history of other malignancies prior to study entry, with the exception of:
Adequately treated in situ carcinoma of the cervix uteri or carcinoma in situ of breast;
Basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin;
Previous malignancy confined and surgically resected (or treated with other modalities) with curative intent.
Subject has a white blood cell count > 25 × 10^9/L. Note: Hydroxyurea is permitted to meet this criterion.
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There are 22 Locations for this study
Duarte California, 91010, United States
Sacramento California, 95817, United States
Aurora Colorado, 80045, United States
Atlanta Georgia, 30322, United States
Chicago Illinois, 60611, United States
Chicago Illinois, 60637, United States
Baltimore Maryland, 21287, United States
Boston Massachusetts, 02215, United States
New York New York, 10032, United States
Durham North Carolina, 27710, United States
Houston Texas, 77030, United States
Houston Texas, 77030, United States
Seattle Washington, 98109, United States
Kogarah New South Wales, 2217, Australia
Melbourne Victoria, 3000, Australia
Melbourne Victoria, 3004, Australia
Pessac CEDEX Gironde, 33604, France
Toulouse Haute-Garonne, 31059, France
Paris , 75010, France
Ulm Baden-Wuerttemberg, 89081, Germany
Leipzig Sachsen, 04103, Germany
Dresden , 01307, Germany
Munich , 81675, Germany
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