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)
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 combination of venetoclax and azacitidine for people with acute
myeloid leukemia (AML) that are over the age of 75 or who have comorbidities that preclude
intensive induction chemotherapy.
Venetoclax may interact with BCL-2 (a protein that initiates tumor growth, disease
progression, and drug resistance) and inhibit BLC-2 which can lead to cancer cell death.
Azacitidine may cause cell death in rapidly dividing cells, which may lead to cancer cell
death since cancer cells do not grow at a normal rate. Induction Chemotherapy which includes
the drugs idarubicin or daunorubicin, cytarabine, and liposomal daunorubicin and cytarabine
is the standard of care chemotherapy treatment for someone with acute myeloid leukemia (AML).
The research study procedures include screening for eligibility and study treatment,
including evaluations and follow up visits.
Participants will receive study treatment for as long as they and their doctor believe they
are benefitting from the study drugs. Participants will then be followed for 3 years or until
they withdraw their consent to be contacted.
It is expected that about 172 people will take part in this research study.
AbbVie, a biopharmaceutical company, is supporting this research study by providing funding
for the study, including one of the study drugs.
Acute Myeloid Leukemia
Liposomal daunorubicin and cytarabine
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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