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
Acute Myeloid Leukemia (AML), Cancer
About this trial
This is an interventional treatment trial for Acute Myeloid Leukemia (AML) focused on measuring Acute Myeloid Leukemia (AML), Cancer, Treatment-naïve, Venetoclax, Azacitidine, Decitabine, Outpatient setting
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
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
Sites / Locations
- Arizona Oncology Associates, PC-HOPE /ID# 211509
- Colorado Blood Cancer Institute /ID# 212800
- Rocky Mountain Cancer Centers /ID# 211508
- Fort Wayne Medical Oncology /ID# 223523
- Minnesota Oncology Hematology, PA /ID# 212837
- Oncology Hematology Care, Inc. /ID# 212779
- Willamette Valley Cancer Institute and Research Center /ID# 211504
- Charleston Oncology, P.A. /ID# 211471
- Prisma Health Cancer Inst - Eastside /ID# 211466
- Tennessee Oncology - Chattanooga / McCallie /ID# 212717
- Tennessee Oncology-Nashville Centennial /ID# 210944
- Texas Oncology - Austin Midtown /ID# 212780
- Texas Oncology - Medical City Dallas /ID# 211503
- Texas Transplant Institute /ID# 213311
- Texas Oncology - San Antonio Medical Center /ID# 211510
- Texas Oncology - Northeast Texas /ID# 213908
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Venetoclax 400 mg + azacitidine 75 mg
Venetoclax 400 mg + decitabine 20 mg
Participants received venetoclax orally daily for 28-day cycles, for a maximum of 6 cycles, beginning on Cycle 1 Day 1. The venetoclax dosing ramp-up schedule was 100 mg on Cycle 1 Day 1, 200 mg on Cycle 1 Day 2, and 400 mg on Cycle 1 Days 3 -28 and 400 mg daily for each 28-day cycle thereafter. Azacitidine (75 mg/m^2) was administered subcutaneously or intravenously per investigator's choice and institutional practice for 7 days beginning on Day 1 of each 28-day cycle.
Participants received venetoclax orally daily for 28-day cycles, for a maximum of 6 cycles, beginning on Cycle 1 Day 1. The venetoclax dosing ramp-up schedule was 100 mg on Cycle 1 Day 1, 200 mg on Cycle 1 Day 2, and 400 mg on Cycle 1 Days 3 -28 and 400 mg daily for each 28-day cycle thereafter. Decitabine (20 mg/m^2) was administered intravenously per investigator's choice and institutional practice for 5 days beginning on Day 1 of each cycle.