A Phase 1b Study of ABT-199 (GDC-0199) in Combination with Azacitidine or Decitabine in Treatment Naive Subjects with Acute Myelogenous Leukemia Who Are >/= 60 Years of Age and Who Are Not Eligible for Standard Induction Therapy
This is a 2 part study: dose escalation and dose expansion. The goal of Part 1 (dose escalation) of this clinical research study is to find the highest tolerable dose of venetoclax (ABT-199) when given in combination with either decitabine or azacitidine in patients who have AML and are 65 years of age or older. The safety of this drug combination will also be studied. The goal of Part 2 (dose expansion) of this clinical research study is to learn if the highest tolerable dose of venetoclax and either decitabine or azacitidine found in Part 1 can help to control AML.The study doctor will discuss this in more detail with you. This consent form is for Part 1 only. MD Anderson will only be enrolling participants to receive Venetoclax and decitabine. The safety of venetoclax will be studied in both parts of this study.
Treatment Location: N/A
The primary objective is to evaluate the safety and pharmacokinetics of venetoclax administered orally in combination with decitabine or azacitidine in treatment naïve subjects with Acute Myelogenous Leukemia (AML) who are greater than or equal to 65 years of age and who are not eligible for standard induction therapy due to co-morbidity or other factors. Secondary objectives include assessing the preliminary efficacy of venetoclax administered orally in combination with either decitabine or azacitidine in this patient population. Exploration of biomarkers that may serve as surrogates for clinical endpoints for future venetoclaxcombinations or single agent studies may be performed.
IRB Review and Approval Date: 10/07/2014
Recruitment Status: Closed
Projected Accrual: N/A
Information and next steps
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