Clareo Health | A Study of the Effectiveness of Venetoclax in Combination With Azacitidine or Decitabine in an Outpatient Setting in Patients With Acute Myeloid Leukemia (AML) Ineligible for Intensive Chemotherapy
A Study of the Effectiveness of Venetoclax in Combination With Azacitidine or Decitabine in an Outpatient Setting in Patients With Acute Myeloid Leukemia (AML) Ineligible for Intensive Chemotherapy
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
AbbVie
Age
12–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Participant has confirmation of acute myeloid leukemia (AML) by World Health Organization (WHO) criteria
Participant is deemed by the investigator to be an appropriate candidate for outpatient ramp-up of venetoclax
You may not be if
Participant has not received prior treatment for AML (treatment naïve) with the exception of hydroxyurea
Participant has no evidence of spontaneous tumor lysis syndrome (TLS) at Screening
Participant can have progressed from myelodysplastic syndrome (MDS) or be considered to have secondary AML and could have been treated with growth factors or other agents with the exception of hypomethylating agents
Participant has adequate kidney, liver, and hematology laboratory values as detailed in the protocol
Has an Eastern Cooperative Oncology Group (ECOG) Performance status of 0 to 3
Has a history of the following conditions:
Acute promyelocytic leukemia
Known active central nervous system involvement with AML
Positive for HIV (HIV testing is not required)
Positive for hepatitis B or C infection with the exception of those with an undetectable viral load within 3 months
Cardiovascular disability status of New York Heart Association Class \> 2
Chronic respiratory disease that requires continuous oxygen or any other medical condition that in the opinion of the investigator would adversely affect his/her participating in this study
Malabsorption syndrome or other condition that precludes enteral route of administration
Has a history of other malignancies within 2 years 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
