A Phase 2 Randomized Study Comparing Venetoclax and Azacitidine to Induction Chemotherapy for Newly Diagnosed Fit Adults With Acute Myeloid Leukemia
Massachusetts General Hospital
Summary
This research is being done to assess the therapeutic activity of a promising combination (azacitidine and venetoclax) versus conventional cytotoxic chemotherapy in induction-eligible patients with acute myeloid leukemia. This study involves the following: * Venetoclax and azacitidine (investigational combination) * Cytarabine and idarubicin or daunorubicin (per standard of care) or Liposomal daunorubicin and cytarabine (per standard of care)
Description
This is an open-label, multicenter, phase II randomized clinical trial to compare the therapeutic activity of conventional induction chemotherapy (7+3 regimen or liposomal daunorubicin and cytarabine) to the combination of venetoclax and azacitidine among fit, traditionally induction-eligible adults with newly diagnosed acute myeloid leukemia (AML). The U.S. Food and Drug Administration (FDA) has approved the combinations of liposomal daunorubicin and cytarabine as well as cytarabine and idarubicin or daunorubicin as treatment options for acute myeloid leukemia (AML) The FDA has approved the…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Age ≥ 18 years * Participants must have pathologically confirmed, newly diagnosed acute myeloid leukemia (AML), and characterized by 20% or more blasts in the peripheral blood or bone marrow. The AML may be either: * De Novo: AML in patients with no clinical history of prior myelodysplastic syndrome (MDS), myeloproliferative disorder, or exposure to potentially leukemogenic therapies or agents * Secondary AML (sAML): refers to an acute leukemic process (1) evolving from known prior myelodysplasia, myeloproliferative disorder, or aplastic anemia with or without treat…
Interventions
- DrugCytarabine
Intravenous infusion
- DrugIdarubicin
Intravenous infusion
- DrugDaunorubicin
Intravenous infusion
- DrugLiposomal daunorubicin and cytarabine
Intravenous infusion
- DrugVenetoclax
Orally by mouth
- DrugAzacitidine
Intravenous infusion
Locations (9)
- City of HopeDuarte, California
- Stanford Cancer CenterPalo Alto, California
- University of California - DavisSacramento, California
- Massachusetts General Hospital Cancer CenterBoston, Massachusetts
- Beth Israel Deaconess Medical CenterBoston, Massachusetts
- Dana-Farber Cancer InstituteBoston, Massachusetts