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 Phase 3b, Single-Arm, Multicenter Open-Label Study of Venetoclax in Combination With Azacitidine or Decitabine in an Outpatient Setting in AML Patients Ineligible for Intensive Chemotherapy
1 other identifier
interventional
60
1 country
16
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Aug 2019
Typical duration for phase_3
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 3, 2019
CompletedFirst Posted
Study publicly available on registry
May 8, 2019
CompletedStudy Start
First participant enrolled
August 15, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 14, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
March 14, 2022
CompletedResults Posted
Study results publicly available
March 20, 2023
CompletedMarch 20, 2023
February 1, 2023
2.6 years
May 3, 2019
February 22, 2023
February 22, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With Complete Remission or Complete Remission With Incomplete Blood Count Recovery (CR + CRi)
The composite complete remission rate is defined as the percentage of participants with complete remission (CR) or complete remission with incomplete blood count recovery (CRi) at any time during the study as assessed by the investigator. Response was based on bone marrow results and hematology values according to the modified International Working Group (IWG) criteria for AML: CR: Absolute neutrophil count (ANC) \> 10\^3/μL (1,000/μL), platelets \> 10\^5/μL (100,000/μL), red blood cell (RBC) transfusion independence, and bone marrow with \< 5% blasts CRi: Bone marrow with \< 5% blasts, and absolute neutrophils of ≤ 10\^3/μL or platelets ≤ 10\^5/μL
Assessed at Cycle 1 end, at Cycle 2 end if CR/CRi wasn't achieved at Cycle 1 end, or Cycle 4 end if CR/CRi wasn't achieved at Cycle 2 end. Median treatment duration of venetoclax was 16.1 wks (range 3.9-38.1) and 21.1 wks (range 2.7-40.4), respectively.
Secondary Outcomes (3)
Percentage of Participants With Complete Remission (CR)
Assessed at Cycle 1 end, at Cycle 2 end if CR/CRi wasn't achieved at Cycle 1 end, or Cycle 4 end if CR/CRi wasn't achieved at Cycle 2 end. Median treatment duration of venetoclax was 16.1 wks (range 3.9-38.1) and 21.1 wks (range 2.7-40.4), respectively.
Percentage of Participants With Complete Remission With Incomplete Blood Count Recovery (CRi)
Assessed at Cycle 1 end, at Cycle 2 end if CR/CRi wasn't achieved at Cycle 1 end, or Cycle 4 end if CR/CRi wasn't achieved at Cycle 2 end. Median treatment duration of venetoclax was 16.1 wks (range 3.9-38.1) and 21.1 wks (range 2.7-40.4), respectively.
Percentage of Participants With Post-baseline Transfusion Independence
From the first dose of study drug to the last dose of study drug +30 days, or death, or initiation of post-treatment therapy, whichever occurred earliest. Median time on follow-up was 183.5 days and 195.0 days, respectively.
Study Arms (2)
Venetoclax 400 mg + azacitidine 75 mg
EXPERIMENTALParticipants 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.
Venetoclax 400 mg + decitabine 20 mg
EXPERIMENTALParticipants 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.
Interventions
Venetoclax tablets were to be taken orally once daily with a meal and water in the morning at approximately the same time each day. Tablets were to be swallowed whole and not chewed, crushed, or broken prior to swallowing. On the days that the participant received either azacitidine or decitabine, venetoclax was dosed in clinic and administered prior to these agents.
The azacitidine infusion was prepared and administered per the package insert and given either subcutaneously or intravenously, per institutional practice.
The decitabine infusion was prepared and administered per the package insert and given intravenously, per institutional practice.
Eligibility Criteria
You may qualify 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
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AbbVielead
Study Sites (16)
Arizona Oncology Associates, PC-HOPE /ID# 211509
Tempe, Arizona, 85284-1812, United States
Colorado Blood Cancer Institute /ID# 212800
Denver, Colorado, 80218, United States
Rocky Mountain Cancer Centers /ID# 211508
Lone Tree, Colorado, 80124, United States
Fort Wayne Medical Oncology /ID# 223523
Fort Wayne, Indiana, 46804, United States
Minnesota Oncology Hematology, PA /ID# 212837
Minneapolis, Minnesota, 55404, United States
Oncology Hematology Care, Inc. /ID# 212779
Cincinnati, Ohio, 45236-2725, United States
Willamette Valley Cancer Institute and Research Center /ID# 211504
Eugene, Oregon, 97401-6043, United States
Charleston Oncology, P.A. /ID# 211471
Charleston, South Carolina, 29414-7710, United States
Prisma Health Cancer Inst - Eastside /ID# 211466
Greenville, South Carolina, 29615, United States
Tennessee Oncology - Chattanooga / McCallie /ID# 212717
Chattanooga, Tennessee, 37404-3230, United States
Tennessee Oncology-Nashville Centennial /ID# 210944
Nashville, Tennessee, 37203-1632, United States
Texas Oncology - Austin Midtown /ID# 212780
Austin, Texas, 78705, United States
Texas Oncology - Medical City Dallas /ID# 211503
Dallas, Texas, 75230, United States
Texas Transplant Institute /ID# 213311
San Antonio, Texas, 78229, United States
Texas Oncology - San Antonio Medical Center /ID# 211510
San Antonio, Texas, 78240-5251, United States
Texas Oncology - Northeast Texas /ID# 213908
Tyler, Texas, 75702, United States
Related Publications (1)
Manda S, Anz BM 3rd, Benton C, Broun ER, Yimer HA, Renshaw JS, Geils G Jr, Berdeja J, Cruz J, Melear JM, Fanning S, Fletcher L, Li Y, Duan Y, Werner ME, Potluri J, Pai MV, Donnellan WB. A phase 3b study of venetoclax and azacitidine or decitabine in an outpatient setting in patients with acute myeloid leukemia. Hematol Oncol. 2024 May;42(3):e3274. doi: 10.1002/hon.3274.
PMID: 38711253DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Global Medical Services
- Organization
- AbbVie
Study Officials
- STUDY DIRECTOR
ABBVIE INC.
AbbVie
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
- Expanded Access
- Yes
Study Record Dates
First Submitted
May 3, 2019
First Posted
May 8, 2019
Study Start
August 15, 2019
Primary Completion
March 14, 2022
Study Completion
March 14, 2022
Last Updated
March 20, 2023
Results First Posted
March 20, 2023
Record last verified: 2023-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
- Access Criteria
- Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.