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 evaluating the effectiveness and safety of venetoclax, in combination with azacitidine or decitabine, in an outpatient setting for treatment-naïve participants with AML who are ineligible for intensive chemotherapy.
Arms and Interventions
|Experimental: Ventoclax + azacitidine or decitabine|
Venetoclax (daily for 28 days), in combination with azacitidine or decitabine, beginning on Cycle 1 Day 1. Depending on investigator's choice, participants will receive either azacitidine for 7 days beginning on Day 1 of each 28-day cycle or decitabine for 5 days beginning on Day 1 of each 28-day cycle, as per institutional practice.
infusion; subcutaneous or intravenous
Primary Outcome Measures
- Composite Complete Remission Rate (CR + CRi) [Up to approximately 24 weeks]
The Composite Complete Remission Rate (CR + CRi) is defined as the proportion of participants who achieve complete remission (CR) plus participants who achieve complete remission with incomplete hematologic recovery (CRi) as described by the modified International Working Group (IWG) criteria for Acute Myeloid Leukemia (AML).
Secondary Outcome Measures
- Overall Response Rates (CR, CRi) [Up to approximately 24 weeks]
Overall Response Rates to treatment is the proportion of participants who achieve complete remission or complete remission with incomplete hematologic recovery, based on guidelines adapted from the IWG for AML.
- Percent of Participants who Achieve Transfusion Independence [Up to at least 56 days after initial administration of study drug]
Transfusion Independence: the rate of red blood cell (RBC) and platelet transfusion dependence (defined as having received ≥ 2 units of RBCs and/or platelets within 56 days prior to study) at baseline and assess transfusion independence, defined as at least 56 consecutive days without a RBC or platelet transfusion during the treatment period.
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.
Participant is not eligible to receive treatment with standard cytarabine and anthracycline induction regimens.
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
Contacts and Locations
|1||Arizona Oncology Associates, PC-HOPE /ID# 211509||Tempe||Arizona||United States||85284-1812|
|2||Colorado Blood Cancer Institute /ID# 212800||Denver||Colorado||United States||80218|
|3||Rocky Mountain Cancer Centers /ID# 211508||Lone Tree||Colorado||United States||80124|
|4||Fort Wayne Medical Oncology /ID# 223523||Fort Wayne||Indiana||United States||46804|
|5||Minnesota Oncology Hematology, PA /ID# 212837||Minneapolis||Minnesota||United States||55404|
|6||Oncology Hematology Care, Inc - Kenwood /ID# 212779||Cincinnati||Ohio||United States||45236-2725|
|7||Willamette Valley Cancer Institute /ID# 211504||Eugene||Oregon||United States||97401-6043|
|8||Charleston Oncology, P.A. /ID# 211471||Charleston||South Carolina||United States||29414-7710|
|9||Prisma Health Cancer Inst - Eastside /ID# 211466||Greenville||South Carolina||United States||29615|
|10||Tennessee Oncology - Chattanooga / McCallie /ID# 212717||Chattanooga||Tennessee||United States||37404-3230|
|11||Tennessee Oncology-Nashville Centennial /ID# 210944||Nashville||Tennessee||United States||37203-1632|
|12||Texas Oncology - Austin Midtown /ID# 212780||Austin||Texas||United States||78705|
|13||Texas Oncology - Medical City Dallas /ID# 211503||Dallas||Texas||United States||75230|
|14||Texas Transplant Institute /ID# 213311||San Antonio||Texas||United States||78229|
|15||Texas Oncology - San Antonio Medical Center /ID# 211510||San Antonio||Texas||United States||78240-5251|
|16||Texas Oncology - Tyler /ID# 213908||Tyler||Texas||United States||75702|
Sponsors and Collaborators
- Study Director: ABBVIE INC., AbbVie
Study Documents (Full-Text)None provided.