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Nucleoside Metabolic Inhibitor
Venetoclax + Azacitidine for Acute Myeloid Leukemia (Viale-a Trial)
Phase 3
Waitlist Available
Research Sponsored by AbbVie
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participant must have adequate renal function as demonstrated by a creatinine >= 30 mL/min.
Participant must have confirmation of Acute Myeloid Leukemia (AML) by World Health Organization (WHO) criteria, previously untreated and be ineligible for treatment with a standard cytarabine and anthracycline induction regimen due age or comorbidities.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from the study start up to death or alive or lost to follow-up (up to approximately 4.8 years; data cut off date: 1 december 2021)
Awards & highlights
Viale-a Trial Summary
This trial is testing a new combination treatment for acute myeloid leukemia (AML), a cancer of the blood and bone marrow. The treatment consists of the experimental drug venetoclax, which kills cancer cells by blocking a protein that allows them to stay alive, combined with azacitidine. The study will enroll approximately 400 participants globally and will compare the efficacy of the new combination treatment to azacitidine alone.
Who is the study for?
This trial is for adults diagnosed with Acute Myeloid Leukemia (AML) who haven't been treated before and can't have standard chemotherapy due to age or health issues. They must be expected to live at least 12 weeks, able to consent, and if of childbearing potential, agree to use birth control.Check my eligibility
What is being tested?
The study tests whether Venetoclax combined with Azacitidine is more effective than Azacitidine alone in treating AML. It's a Phase 3 trial where two-thirds of the patients will receive both drugs while one-third will get a placebo with Azacitidine.See study design
What are the potential side effects?
Venetoclax may cause side effects like low white blood cell count increasing infection risk, diarrhea, nausea, fatigue, and possibly liver problems. Azacitidine can also cause blood disorders, stomach issues, pain at injection site and fever.
Viale-a Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My kidneys work well enough, with a creatinine clearance rate of at least 30 mL/min.
Select...
I have AML, untreated, and can't have standard treatment due to my age or health issues.
Select...
I am 18 years old or older.
Select...
I am over 75 or have certain health issues that make me ineligible for initial cancer treatment.
Viale-a Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from the study start up to death (up to approximately 4.8 years; data cut-off date: 1 december 2021)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from the study start up to death (up to approximately 4.8 years; data cut-off date: 1 december 2021)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall Survival (OS)
Percentage of Participants With Complete Remission (CR) and Complete Remission With Incomplete Marrow Recovery (CRi)
Secondary outcome measures
Complete Remission (CR) Rate
Complete Remission or Complete Remission With Partial Hematologic Recovery Rate (CR+CRh)
Event-free Survival (EFS)
+4 moreViale-a Trial Design
3Treatment groups
Active Control
Placebo Group
Group I: Group 1 and Group 2: Venetoclax 100 mg/200 mg/400 mg + Azacitidine 75 mg/m^2Active Control2 Interventions
Participants enrolled under original protocol and enrolled during or after protocol amendment 1 received venetoclax 100 mg, once orally, on Day 1 of Cycle 1 followed by venetoclax 200 mg, once orally, on Day 2 of Cycle 1 and venetoclax 400 mg, orally, QD, on Day 3 to Day 28 of each 28 day cycle along with azacitidine 75 mg/m^2, SC or IV, QD for 7 days from Day 1 of each 28-day cycle until documented disease progression, unacceptable toxicity, withdrawal of consent, or other protocol criteria for discontinuation (whichever occurred first).
Group II: Open Label China Cohort: Venetoclax 400 mg + Azacitidine 75 mg/m^2Active Control2 Interventions
Participants received venetoclax 400 mg, orally, QD, from Day 1 to Day 28 of each 28 day cycle along with azacitidine 75 mg/m^2, SC, QD for 7 days from Day 1 of each 28-day cycle until documented disease progression, unacceptable toxicity, withdrawal of consent, or other protocol criteria for discontinuation (whichever occurred first).
Group III: Group 1 and Group 2: Placebo + Azacitidine 75 mg/m^2Placebo Group2 Interventions
Participants enrolled under original protocol and enrolled during or after protocol amendment 1 received venetoclax-matching placebo, orally, every day (QD), from Day 1 to Day 28 of each 28 day cycle along with azacitidine 75 mg/m^2, subcutaneously (SC) or intravenously (IV), QD for 7 days from Day 1 of each 28-day cycle until documented disease progression, unacceptable toxicity, withdrawal of consent, or other protocol criteria for discontinuation (whichever occurred first).
Find a Location
Who is running the clinical trial?
AbbVieLead Sponsor
954 Previous Clinical Trials
500,601 Total Patients Enrolled
Genentech, Inc.Industry Sponsor
1,539 Previous Clinical Trials
567,246 Total Patients Enrolled
ABBVIE INC.Study DirectorAbbVie
394 Previous Clinical Trials
145,435 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently being treated for a serious infection.I am over 18 and can care for myself, but my ability to do daily activities may vary with my age.My kidneys work well enough, with a creatinine clearance rate of at least 30 mL/min.I am a woman who can have children and my pregnancy test is negative.I have had CAR-T cell therapy or experimental treatments for my blood cancer.I have acute promyelocytic leukemia or active AML in my brain or spinal cord.I am HIV positive or have hepatitis B or C.I have AML, untreated, and can't have standard treatment due to my age or health issues.My liver is functioning well, not affected by leukemia.I am a woman who is either post-menopausal or using birth control.I have been treated for MDS or AML with specific medications.I have taken certain medications or eaten specific foods recently.I am 18 years old or older.I am a man and will use contraception as required.I do not have any major health issues that would affect my participation.I am over 75 or have certain health issues that make me ineligible for initial cancer treatment.I have a history of blood disorders or specific genetic changes.I have had cancer other than my current one in the last 2 years, with some exceptions.I cannot take medicine by mouth due to a digestive issue.
Research Study Groups:
This trial has the following groups:- Group 1: Group 1 and Group 2: Venetoclax 100 mg/200 mg/400 mg + Azacitidine 75 mg/m^2
- Group 2: Group 1 and Group 2: Placebo + Azacitidine 75 mg/m^2
- Group 3: Open Label China Cohort: Venetoclax 400 mg + Azacitidine 75 mg/m^2
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are patients being sought out for this experiment as we speak?
"This research is no longer looking for participants. Although, when it was active, the study was posted on February 2nd, 2017 and last updated on June 29th, 2022. There are 1586 other trials actively recruiting patients with leukemia and 350 trials for Venetoclax followed by Azacitidine."
Answered by AI
What are the benefits that patients in this trial can expect?
"The primary objective for this study, which will be observed over a 2-year period, is to track the percentage of patients that enter complete remission (CR) or complete remission with incomplete marrow recovery (CRi). Additionally, the study will also collect data on secondary outcomes including the rate of conversion for red blood cells (RBC) and platelets, post-baseline transfusion independence rate, and fatigue/quality of life (QoL)."
Answered by AI
Has the FDA greenlighted the use of Venetoclax in tandem with Azacitidine?
"There is some clinical data supporting the efficacy of Venetoclax followed by Azacitidine, and this has been corroborated by multiple rounds of safety trials, so it received a score of 3."
Answered by AI
Are there any other examples of clinical trials that use Venetoclax in combination with Azacitidine?
"350 research studies are underway that involve Venetoclax followed by Azacitidine. 55 of those studies are in Phase 3. Although the majority of trials for Venetoclax followed by Azacitidine are based in Edmonton, Alberta, 11235 locations are running studies for this treatment."
Answered by AI
What disease are Venetoclax and Azacitidine most often used together to target?
"Induction chemotherapy can be treated with the drug regimen of Venetoclax followed by Azacitidine. This treatment is also effective for other blood disorders like refractory anemias, leukemia, myelocytic, acute, and multilineage dysplasia."
Answered by AI
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